PATIENT HELPER ADAPTER (HEIGHT ADJ)
Received Apr 4, 2012 · Event occurred Mar 1, 2012
Report 1035617-2012-00002 · MDR key 2521021
Device
Generic name
Patient Helper Adapter (height Adj)
Manufacturer
Zimmer SurgicalModel number
NACatalog number
00-0965-002-01
Lot number
NA
Product problems
- Bent
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE SLEEVE SECTION OF THE PT HELPER BENT WHERE IT ATTACHES TO THE BED BRACKET. ADDITIONAL CLINICAL FOLLOW UP WITH THE HOSPITAL INDICATED THAT THE PT HELPER HAD BEEN ON THE PT'S BED PROVIDING TRAPEZE USE FOR QUITE SOME TIME. THE RN STATED THE PT WAS CONSIDERED TO BE QUITE PROACTIVE WITH PHYSICAL THERAPY AND SELF EXERCISE TO REGAIN LIMB FUNCTION AND STRENGTH. THE RN STATED THE PT WAS "DOING CHIN-UPS ON THE TRAPEZE, LIFTING HIS FULL BODY WEIGHT COMPLETELY OFF THE BED, WHEN THE PT NOTED THE BAR TO BE BENDING SLIGHTLY OVER THE BED." THE RN STATED THE PT WAS NOT HARMED AND NEITHER THE TRAPEZE NO THE PT HELPER FELL.
Additional Manufacturer Narrative
THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER AT THE TIME OF THIS REPORT. A FOLLOW UP MEDWATCH WILL BE SUBMITTED ONCE THE DEVICE HAS BEEN RETURNED AND THE INVESTIGATION IS COMPLETE.