MEDLINE
Received Jul 29, 2026 · Event occurred Sep 30, 2025
Report 1417592-2026-11571 · MDR key 50070394
Device
Product problems
- Electrical /Electronic Property Problem
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
It was reported that the control box is malfunctioning. Per video, the control box seems to be unable to function unless the pendant bale is forced into the control box and when this act is being performed the LCD screen displays a blacked out box.
Additional Manufacturer Narrative
It was reported that the control box has been issued. control box is malfunctioning. The control box seems to be unable to function unless the pendant bale is forced into the control box and when this act is performed the LCD screen displays a blacked-out box. 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.