An article in the August 22, 2003, Los Angeles Times by Charles Ornstein and Tracy Weber, Times Staff Writers, describes an incident where “two patients die after alarms fail”.
Read article: LATimesarticle822
FDA: Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices
Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803. Read more: https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices