Two paramedics went to help a person suffering a heart attack. They used a high-tech medical device designed to save the suffering victim. Not only did the device malfunction, allowing the patient to die, but it also severely jolted both paramedics putting them in the hospital. Chris Szechenyi, an investigative reporter at WRC-TV in Washington, D.C., called MICAR with news of a medical device malfunctions database.

He knew the Medical Device Report (MDR) tape was more than just useful; it would be a blockbuster tape. The tape includes every malfunction associated with medical devices in the past five years, including any medical device used in the United States. Even those devices manufactured overseas but used in the U.S. are reported on this tape. If a medical device is used on a patient and it fails, resulting in the death or injury of that patient, the responsible device must be reported to the Food and Drug Administration.

For example, if a hip implant is used for a patient who has broken a hip and that implant fractures during normal activity, resulting in the death of the patient, the device must then be reported to the FDA. Szechenyi, a veteran medical reporter, knew of this sort of data. Once he heard of MICAR, he put two and two together. He sent the tape to Elliot Jaspin at MICAR. The first thing Jaspin did with the data was determine which company had the most number of deaths associated with products.

Physio Control Corp., a manufacturer of defibrillators, floated to the top. Defibrillators are devices that deliver an electric shock returning normal heart beat during cardiac arrest. If a defibrillator fails, the patient will almost certainly die. Physio Control products have been associated with more deaths than any other group of devices reported in the database. Physio Control defibrillators have contributed to the deaths of more than 400 patients over the past five years.

The FDA records show that the corporation is responsible for the most deaths directly due to defibrillators. One product in particular, the LIFEPAK 5 defibrillator, has been associated with more deaths than any other device. Once Szechenyi filed a FOIA request for all Physio Control records through the FDA, he discovered that the company had 13 recalls and three safety alerts during the past five years.

Some of the recalls were voluntary, but the FDA still had to demand that defects be fixed. The FDA record showed however, that Physio Control resisted these demands. Using the MDR database as a roadmap, Szechenyi discoverd that Physio Control was not the only defibrillator company with a lot of recalls and safety alerts. He also discovered the FDA has failed to set market standards for defibrillators.

Neither the FDA nor Physio Control would discuss the matter with Szechenyi. But that didn't bother Tom Brokaw. A small portion of Szechenyi's story aired on NBC Nightly News, and Szechenyi's entire four-part series "Fatal Flaws" aired on all NBC owned-and-operated stations in New York, Los Angeles, Denver, Miami, Cleveland and Chicago. There are more than 100,000 records on the MDR and defibrillators represent only a small portion.

There's plenty more to be done with the record for national and local stories. David Hinchman was able to broadcast a three- part version of the defibrillator story for KOMU-TV in Columbia. Hinchman is available through MICAR to answer any questions concerning MDR. If you want to use MDR. The volume is 3 reels, 6250 bpi, EBCDIC and avalible through NTIS (# pb90-591610) NTIS phone number is 703-487-4848.

But at the time this issue of Uplink was printed, the NTIS sales desk was closed due to a fire in their computer room. MICAR can provide the volume (updated through Sept. 1990) for $300.