MalfunctionILZ
DELUXE TRAPEZE
Received Jul 13, 2007 · Event occurred Jan 31, 2007
Report 2921578-2007-00002 · MDR key 880637
Device
Product problems
- Detachment Of Device Component
- Component Falling
Patient
50 YR
- Abrasion
- Swelling
Narrative
Additional Manufacturer Narrative
THE PRODUCT IS DESIGNED TO WITHSTAND A 250 LB PATIENT, THE S-HOOK THAT FAILED ON THE TRAPEZE (MASTER LINK TO CONNECT CHAIN TO TRAPEZE AND TO CLAMP) IS DESIGNED TO WITHSTAND 300 LBS. IT APPEARS TO BE A USER ERROR, POSSIBLY DUE TO REVIEW OF DEVICE BEFORE AND AFTER INSTALLATION ON HOSPITAL BEDS.
Description of Event or Problem
AS PER THE HOSPITAL REPRESENTATIVE, THE PATIENT WAS LYING IN BED USING THE TRAPEZE TO SCOOT UP ON THE HOSPITAL BED. THE TRAPEZE SUB-COMPONENT "D" RING FAILED AND PART FELL ONTO PATIENT'S HEAD. PATIENT EXPERIENCED SWELLING AND ENDURED A SMALL ABRASION ON TOP OF HIS HEAD.