REXX
Received Apr 7, 2014 · Event occurred Mar 12, 2014
Report 1041130-2014-00001 · MDR key 3763385
Device
Generic name
Qd2000
Model number
QD2000Product problems
- Human-Device Interface Problem
Patient
Not reported
- Laceration(s)
Narrative
Additional Manufacturer Narrative
AFTER A REVIEW OF OUR POST PRODUCTION RISK MGMT, THIS IS THE FIRST INCIDENT OF THIS NATURE AND CONSIDERED ISOLATED WITH A LIKELIHOOD OF OCCURRENCE BEING IMPROBABLE. OUR RISK ANALYSIS WAS REVIEWED AND PROPER WARNINGS ARE COVERED IN THE OWNER'S MANUAL. NO CORRECTIVE ACTION(S) REQUIRED.
Description of Event or Problem
A RESIDENT WAS SITTING ON THE SIDE OF HER BED. A GARBAGE CAN HAD BEEN PLACED IN THE CLOSE PROXIMITY OF THE BED FOR THE RESIDENTS USE, WHICH WAS UNDER THE BED'S EDGE AT THE TIME OF BED LOWERING. THE GARBAGE CAN WAS LOCATED BETWEEN THE PIVOT POINT OF THE HEAD DECK AND HEAD END OF THE BED. THE RESIDENT SIMULTANEOUSLY LOWERED THE BED AND RAISED THE HEAD DECK OF THE BED. THE BED WAS LOWERED ONTO THE GARBAGE CAN AND THE RESIDENT NOTICED THE BED WAS NOT LOWERING PROPERLY BUT CONTINUED TO LOWER. THE BED WAS KEPT FROM LOWERING PROPERLY AT THE HEAD END BY THE GARBAGE CAN. WHILE THE RESIDENT WAS SITTING AND LOWERING THE BED, HER LEGS WERE TUCKED IN UNDER THE BED. THE GARBAGE CAN SUDDENLY POPPED OUT FROM UNDER THE BED, THE BED DROPPED AND HER CALF WAS PARTIALLY SHEARED OFF HER LEG. THE RESIDENT HAD SURGERY AND IS RECOVERING.