|
The customer stated that "there are no functions of the bed that currently work" and later stated that "the cord is broken"; no fall or injury was reported.A physical sample was not provided, and a photo depicting the defect was provided; after reviewing the photo, it was discovered that one of the prongs on the power cord had completely fractured off and the other prong appeared bent but still attached to the power cord.The reported issue was confirmed.Given the evidence provided in the photo, the root cause of this issue is unknown, and the division will monitor through trending.There were no reports of death, serious injury, medical intervention, or follow up care.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this is a reportable event.If additional information becomes available this report will be reopened and reevaluated.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.
|