|
The customer states that the lift base is bent and no injuries were reported on call.A photo depicting the defect was provided; a physical sample was not provided, and only a visual review of the defect could be conducted.Investigation results were confirmed after reviewing the photo provided by the customer, where it appears the base of the lift is bent downward at the point where the tie rod connects, causing the legs to sit unevenly.Given the evidence provided in the photo, as well as the incident report, the root cause of this issue is unknown; no trends were identified for the specified material number and its corresponding defect type, 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.
|