City Halts Use of Heart Gear Called Faulty by Doctors

Equipment used by Santa Ana paramedics to monitor and electrically reset the heartbeat has malfunctioned repeatedly over the past 11 months, possibly jeopardizing some patients’ lives, health care officials said.

The equipment--10 “Liteguard 9” monitor-defibrillators--was removed from the Santa Ana Fire Department’s ambulances April 22 after officials at Western Medical Center, which is the base medical station for the city’s paramedics, documented 82 instances of equipment failure since last June.

The man who recommended that Santa Ana purchase the equipment, paramedic administrator Karl Gilbody, was placed on administrative leave by Santa Ana Fire Chief Allen R. Carter when the county virtually ordered the city to stop using the units two weeks ago.

The company that manufactured the monitors, Maryland-based Survival Technology Inc., says other customers around the country have reported no problems of the nature or scale that Santa Ana has had.

The company’s vice president, Herbert E. Reinhold, said the monitors may not work properly under circumstances peculiar to Santa Ana. But he also said Santa Ana’s paramedics may not have always used the instruments correctly. On April 21, he asked the city to return the units for credit.

Santa Ana was the only city in Orange County using the Liteguard 9 monitors. The city has gone back to the “Life Pak 5” monitors that it previously used and that are used by all other paramedics in the county.

The City Council tonight is scheduled to appropriate money for the emergency purchase of the new monitors, which have already been delivered.

Monitor-defibrillators, when working properly, enable paramedics to transmit a patient’s electrocardiogram by radio to emergency room staff, who can then assess the patient’s condition and direct treatment. Paramedics also use the instruments to deliver an electric shock to the heart.

In some of the cases documented by Western Medical Center staff, the monitors gave inaccurate readouts or went completely blank. Sometimes they were unable to transmit the electrocardiograms back to the hospital.

In a July, 1987, incident involving a convalescent home patient who had suffered a heart attack, the monitor caused a TV set in the room to come on “blaring loudly” each time paramedics tried to transmit the electrocardiogram to the hospital, according to a hospital report.

But a far more serious incident prompted hospital and county officials to urge Santa Ana to immediately discontinue use of the monitors--which the city did.

On April 14, shortly after 4 p.m., Sharon Murray called for help after she found her husband, Wilbert, slumped in a hallway of their apartment on West McFadden Avenue. Paramedics found Murray, 54, in full cardiac arrest. His eyes were fixed but his body was still warm, according to a report signed by paramedic Mike Ciraulo.

The paramedics had two Liteguard 9 units on hand but both failed to work. The equipment failure prevented the paramedics from determining Murray’s heart rhythm or delivering electric current to his heart throughout the entire call, according to Ciraulo’s and the hospital’s reports.

Murray’s heart did not respond to an injection or to CPR. He was taken to Coastal Communities Hospital, where he was pronounced dead due to acute myocardial infarction, or heart attack.

Dr. Carolyn Nelson, medical director of the Western Medical Center emergency room, declined to comment on the case. Santa Ana Fire Chief Carter said the question of whether Murray could have been helped by defibrillation was “a medical question.”

Carter noted that Murray had a history of heart problems and diabetes. He also suffered from hypertension and epileptic seizures, Sharon Murray said.

“I have a feeling he knew he was dying anyway. That’s all he was talking about the last few weeks,” she said.

Dr. Stewart Brash, chairman of the county’s paramedic advisory committee, said he was not familiar with the details of Murray’s case and did not want to comment on it.

But Brash said defibrillation can be “one of the most important things you can deliver if a patient’s heart is in ventricular fibrillation,” which he described as a chaotic rhythm of the heart. “Some people feel that if the (EKG) line is flat (such as in full cardiac arrest), that may be a very fine ventricular fibrillation.”

Five days after Murray died, Nelson fired off a letter to Santa Ana paramedic coordinator Gilbody, noting that Liteguard 9 failures had “dangerously escalated” in the past few weeks.

“This last incident (on April 14) where the backup monitor/defibrillator also failed to function, illustrates we have reached the point where, in the best interests of the citizens of Santa Ana, we must once again remind you your equipment is not meeting minimum performance standards . . . and the patients’ lives are being jeopardized by your continued failure to correct this problem,” said the letter, also signed by Dr. Michael Salem, chairman of Western Medical’s regional paramedic advisory committee, and Laura Maddy, pre-hospital care coordinator.

“Our recent monthly reports have gone unanswered,” the letter continued. “When do you plan to correct this life-threatening situation?”

The hospital officials’ letter said they were requesting that the county Emergency Medical Services Agency, which oversees paramedic programs throughout the county, take “immediate definitive action against any further use of the Liteguard 9.”

Carter ordered the units removed from service three days later.

“The county and Western Med made it real clear that they just didn’t feel that it was appropriate to continue to use them,” he said. “It’s the medical perspective, and you always have to accept the medical perspective.”

Carter, who was hired as chief about five months after the Liteguard 9 monitors were purchased, said problems with the units diminished after Survival Technology representatives flew to Orange County in October to see how they were being used.

The number of incidents in which paramedics reported problems with the monitors dropped from as high as 15 per month to just two in January, he said. But the problems never disappeared.

Carter said the monitors were not removed from service earlier because “Karl (Gilbody) had a strong sense that this equipment was acceptable and appropriate for use here. . . . He wanted every opportunity to demonstrate that the stuff was technically capable.”

Gilbody, contacted last week at home, defended the equipment and blamed many of the reported problems with the Liteguard 9 on health care officials and paramedics who disliked him because he “bucked the system” and who were “anxious to have the things fail.”

“I backed the instrument because it was less expensive and had more modern features than the other one,” said Gilbody, a registered nurse who came to Santa Ana in 1984 after serving for five years as the county’s paramedic coordinator. “It was unpopular because it deviated from the county norm, because I said, ‘Why are we doing these sole-source purchases?’ ”

Until early 1986, the county’s Emergency Medical Services Agency specified one brand and model name for certain types of medical equipment--including monitor-defibrillators--used by paramedic programs. That year, however, in part because of Gilbody’s urging, the county said it would no longer specify brand names but would instead set down performance standards for different kinds of equipment. Cities would then be free to solicit bids from more than one manufacturer.

In September, 1986, Santa Ana purchased 10 Liteguard 9 monitors for $59,000, about $18,000 less than it would have cost to buy the Life Pak 5 monitors everyone else in the county (including Santa Ana, until then) was using.

Gilbody said Santa Ana paramedics had also had problems with the Life Pak monitors.

“If you look at the repair records (of the Liteguard 9 monitors) and the reasons why they weren’t working, and you compare them to Life Pak 5, you’ll probably find as many incidents of them being down,” Gilbody said. “But no one kept statistics until they became a thorn in their side.”

Gilbody said paramedics and health care officials disliked the Liteguard 9 units because they were two pounds heavier than the Life Pak 5. “It’s what everyone else has,” he said. “They want it too.”

Some of the Liteguard monitors the city has had to return for repairs looked like they had been “drop-kicked” by paramedics, he said. “Perhaps they got a lot of abuse because they were unpopular.”

In an April 21 letter to Fire Chief Carter, Survival Technology Vice President Reinhold wrote that company technicians concluded that the monitors might not work properly when used in conjunction with the type of radio employed by Santa Ana paramedics and an internal whip antenna inside a metal ambulance.

When Santa Ana paramedics tested the monitors in the spring of 1986, they used Motorola Corpak radios, and the units functioned properly, Reinhold said. But in the fall, the city switched to the Motorola Apcor radio, and the units began to malfunction, Reinhold said.

In the summer of 1987, after tests showed that additional shielding around the monitors could improve performance, Survival Technology provided Santa Ana with new, shielded Liteguard 9 monitors.

But the problems persisted. On July 31, paramedics were unable to regain a readable heartbeat on the monitor screen after delivering an electric shock to the heart of a 24-year-old man in ventricular tachycardia--a highly dangerous condition in which the heart beats extremely rapidly and cannot pump enough blood.

On Aug. 12, Drs. Nelson and Salem and nurse Maddy wrote to Gilbody that this incident was of “critical concern” and that they had “concerns over our increasing liability with the continued use of equipment which appears to be substandard.”

The hospital officials pointed out to Gilbody that the county’s Drug and Equipment Advisory Group had recommended on Sept. 29, 1986, that the Liteguard 9 monitor not be used by paramedics. The group made its recommendations based on field studies by the Huntington Beach Fire Department, the letter said.

On Sept. 14, the hospital officials wrote another letter to Gilbody, documenting 14 more instances of equipment malfunction--all with the new, shielded monitors.

“We’ve previously indicated to you the seriousness of this problem, yet have not seen any action nor received correspondence indicating corrective measures,” Nelson and Maddy wrote. “It is now your responsibility to rectify this grave situation immediately, as patient care is being jeopardized.”

Reinhold said that “it’s hard to make judgments individually” about the causes of the reported failures. He said he has not been notified of the latest incidents, including the failure of both monitors at Wilbert Murray’s apartment on April 14.

“Did they use it properly?” Reinhold asked. “Each incident has to be analyzed in detail. . . . Under certain circumstances they may not have operated correctly. It’s very difficult to say.”

In his April 21 letter to Carter, Reinhold asked that the Fire Department remove the Liteguard 9 units from service and return them for credit “since we cannot control and insure the proper use of the external roof antenna and additional backup units were not installed as agreed.”

Reinhold pointed out to Carter that when company officials visited Santa Ana in October, the city said it would place Life Pak 5 or similar monitors on ambulances until the technical problems with the Liteguard 9 monitors were solved. “To our knowledge . . . this has not been implemented,” Reinhold said in the letter.

Technicians are still investigating ways to eliminate the kinds of interference problems experienced by Santa Ana paramedics, he wrote.

David Miser, western region representative for the company, said other customers, including the state of California, have not reported similar trouble with the units. At the request of Orange County health officials, the federal Food and Drug Administration is investigating some of the problems reported by Santa Ana, Miser said, but so far the FDA has pronounced the unit well within federal standards.

“The FDA has not asked us to recall anything,” he said.