PATIENT HELPER FRAME HILL-ROM

Description of Event or Problem

ACCOUNT STATES THAT THE PATIENT HELPER, WHEN LOOSENED, SLID DOWN THE ADAPTOR TUBE AND THE TRAPEZE BAR CAME IN CONTACT WITH THE PATIENT'S HEAD. NO PATIENT INJURY OR MEDICAL CARE WAS REQUIRED.

Additional Manufacturer Narrative

DEVICE WAS NOT RETURNED FOR EVALUATION. ZIMMER OSP CONTACTED RISK MANAGER AT ACCOUNT TO GATHER ADDITIONAL DETAILS OF THE EVENT. RISK MANAGER STATED THAT THE HOSPITAL HAD MODIFIED THE DEVICE BECAUSE THE PATIENT HELPER BAR SLID DOWN THE ADAPTOR TUBE AND THE TRAPEZE BAR CAME IN CONTACT WITH THE PATIENT'S HEAD, NO INJURY REPORTED. ZIMMER STATED THAT THE DEVICE IS CURRENTLY UNDER RECALL AND THE DEVICE SHOULD BE RETURNED.