|
The customer reported the bed was being used while "trying to make go up or down" and stated, "bed will not go up and down"; no injuries were reported on call.During the investigation, a sample and/or photo/video was not available, finished good/component trending was performed and no trends were identified, and quality control inspection records were reviewed with the serial number passed inspection.The investigation results were not confirmed.Based on the alleged product failure, it would require technical assistance from the product support team to better diagnose the issue; the customer advised that they could not troubleshoot, and the division will monitor complaints through quarterly 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.
|