Year 2000 Home Page

To Report A Y2K Problem

Immediate Reporting of Possible Y2K-related Problems with Medical Devices by Healthcare Facilities and Manufacturers

If you become aware of a medical device Y2K problem that appears to have serious implications for patient safety, please report it immediately to FDA at our Emergency Operations Center at 301-443-1240, or via the FDA information hotline at 1-888-INFO-FDA (1-888-463-6332) or by FAX to 301-443-3757.

Anyone noting unexpected or unanticipated medical device performance that does or could pose a risk to patients is requested to report via telephone or FAX to the FDA Emergency Operations Center at the numbers given above. Reporters are requested to provide detailed information regarding the specific model of medical device, its manufacturer and the circumstances of the adverse event or unexpected performance. This immediate, optional report via telephone is requested in addition to the normal adverse event report required of medical device manufacturers, distributors and medical device user facilities by Part 803 of Title 21 of the Code of Federal Regulations.

Patients or consumers with concerns regarding a medical device should first contact the physician or other healthcare provider who provided, prescribed or recommended the use of a device, or the manufacturer of the device, for assistance before reporting a problem to the FDA.

FDA will be posted reports of Y2K problems and resolutions on our web page at http://www.fda.gov/cdrh/yr2000/reports.html.

You may also subscribe to an electronic mailing list for immediate notification of these reports. To subscribe, go to: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/dev-alert/alert.cfm.