Medical Device Problem Reporting:

A Case Study of a Home Apnea Monitor

T-PEMD-90-10: Published: Jul 17, 1990. Publicly Released: Jul 17, 1990.

Additional Materials:


Office of Public Affairs
(202) 512-4800

GAO discussed the Food and Drug Administration's (FDA) implementation of the medical device reporting regulation, focusing on reporting problems involving a home apnea monitor. GAO noted that: (1) the monitor's manufacturer received at least 70 complaints associating the monitor with patient deaths between 1983 and 1989; (2) although the manufacturer maintained records of complaints, it did not fully comply with the regulation's reporting requirements; (3) although FDA conducted eight formal inspections between 1984 and 1989, it did not identify or attempt to resolve underreporting problems until 4 years after the regulation went into effect; (4) FDA cited the manufacturer for noncompliance, reviewed the manufacturer's original problem-reporting policy, and concluded that its revised policy was adequate; (5) primary users of the monitors were not always adequately informed of the device's limitations and risks; (6) the manufacturer attributed its noncompliance to differences in interpreting the reporting regulation; (7) FDA inspection procedures did not include any systematic evaluation of trends in the frequency, type, or severity of complaints made to the manufacturer; and (8) FDA did not compare the rates of complaints among manufacturers of similar devices.

Jan 21, 2021

Jan 14, 2021

Jan 4, 2021

Dec 22, 2020

Dec 16, 2020

Dec 14, 2020

Dec 10, 2020

Looking for more? Browse all our products here