Failure to report a voluntary recall to the FDA landed Respire Medical an FDA Form 483 following an April 24 to May 2 inspection at its Brooklyn, New York facility.
The firm issued a recall for its Respire Pink oral sleep apnea device on Sept. 6, 2017, because of a risk of device failure where the arm broke off while in use. Respire issued a recall letter to customers regarding the device failure, but did not report the recall to the FDA.
The firm was also cited for failing to submit a medical device report within 30 days of becoming aware of information that “reasonably suggests that a marketed device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.”
The FDA said the firm did not adequately investigate complaints involving the possible failure of the device. The investigator said the firm documented the failure but “did not properly investigate to determine why the device broke while in use.”
Respire Medical failed to validate the sleep apnea device under defined operating conditions, the FDA said. The firm’s design history file indicated supporting documents for various tasks performed such as design verification, mechanical safety and stability, but the firm was unable to provide any of the supporting documents during the inspection.
Read the Respire Medical Form 483 here: www.fdanews.com/10-03-18-respiremedical483.pdf.