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FDA Medical Device Malfunction Advisory

December 29, 1998

The FDA is warning hospitals, emergency medical services and health care practitioners that the kind of computer date bugs expected to produce problems on January 1, 2000 will affect some medical devices a year early.

Electronic messages posted on the Rx2000 Solutions Institute listserver raise concerns that 15 instruments from seven manufacturers of medical devices will not work correctly after December 31, 1998. The e-mail alleges these products will not be able to accommodate the transition from December 31, 1998 to January 1, 1999.

FDA has worked with all seven manufacturers of these 15 devices to investigate the allegations. Manufacturers of two of the devices have verified that some aspects of the problems can happen. But the remaining manufacturers have reported that the other devices should experience no difficulty in the transition from 1998 to 1999. Some of these products, however, may have problems next year moving from 1999 to 2000.

The two products with verified problems will work properly in direct use so immediate patient care should not be affected. The problems relate to the ability of the device to display, print or store the correct time and date of the device’s operation. While these types of failure do not present an immediate risk to the patient, they do present a potential for confusion and incorrect records.

One product, the Hewlett-Packard 43100A/43200A external defibrillator, will defibrillate properly but will print out "set clock" rather than the month, day, hour, and minute on the paper event record. On trying to reset the clock, the CRT will display a 1985 date. The manufacturer advises it should be reset to 1998 (not 1999) after which the unit will work properly for the year 1999 (because the event record does not print the year, only the month, day, etc.). At the end of 1999 it will need to be reset again, from 1998 to year 2000, after which it should work properly. Thirty-nine thousand of these defibrillators were sold worldwide between 1985 and 1992.

The second product, Invivo Research Inc.’s Millennia 3500 multiparameter patient monitor, has a potential New Year’s Eve problem on every year including 1998-1999. For products manufactured before December 1998, if the display clock is tested or reset as the year turns over, then the display and internal clocks become asynchronous until the product is powered down and restarted. The display clock and paper record can then show different times and dates. The manufacturer advises the problem will not occur if the clock is neither tested nor reset on December 31 - January 1. Invivo has a software upgrade to fix the problem which is available to its customers. This system has been sold since June 1996 and more than 2000 are installed worldwide.

Because these "year 1999" problems exist in two products, there may be other devices with similar, but unidentified problems. Hospitals and other health care facilities should be aware that these types of problems can occur. They should be alert to the date display, printing of date or device permanent records and date recording features of medical devices on or after January 1, 1999. Hospitals and health care facilities should also be alert for other possible date-related problems which may manifest in unexpected ways.

At the same time, device users should be aware that medical devices may be incorrectly identified in posted messages on the Internet as having a transition problem from December 31, 1998 to January 1, 1999. Just because a third party has reported a device having a problem does not mean a problem has been confirmed. A website operated by the FDA at www.fda.gov has product information or links to manufacturer websites which can be consulted, as a first step, for further information. If users have a specific question about a product, they should contact the manufacturer for specific technical information.

Any facility or device user who becomes aware of an unexpected, date-related problem associated with the transition from December 31, 1998 to January 1, 1999 is requested to notify the manufacturer, and report the problem as a malfunction to MedWatch, the voluntary program for reporting problems to FDA, at telephone 1-800-332-1088 or FAX 1-800-332-0178.

Updated December 29, 1998

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