TYPE-S EXTENSION

Description of Event or Problem

THE PATIENT WAS SITTING ON THE COUCH AND WAS INSTRUCTED BY A STAFF MEMBER TO MOVE TOWARD THE HEAD OF THE BED. TO BALANCE THEMSELVES, THE PATIENT GRABBED ONTO THE EXTENSION, AS THEY MOVED INTO POSITION THE EXTENSION LIFTED OFF CAUSING THE PATIENT TO FLIP OFF THE END OF THE BED HEAD FIRST ONTO THE FLOOR. A STAFF MEMBER WHO TRIED TO GRAB THE PATIENT WAS ALSO INJURED. PATIENT RECEIVED A BRUISE ON THE HEAD. PATIENT AND STAFF MEMBER DID NOT RECEIVE TREATMENT AND ARE NOW FINE.

Additional Manufacturer Narrative

METHOD: DEVICE WAS NOT AVAILABLE FOR EVALUATION. THE DISTRIBUTOR'S DESCRIPTION OF EVENTS WAS REVIEWED. RESULTS: PER DISTRIBUTOR, THE EXTENSION HAD A VERY LOOSE FIT AND COULD MOVE UP AND DOWN EXTREMELY EASILY. THE TYPE-S EXTENSION WAS NOT SECURE PRIOR TO USE. THE CLINICIAN ALLOWED THE PATIENT TO REPOSITION THEMSELVES INCORRECTLY, WHICH DIRECTLY CAUSED DETACHMENT. CONCLUSION: IT WAS DETERMINED THAT THE DEVICE WAS USED AGAINST THE PROVIDED INSTRUCTION FOR USE. INSTRUCTIONS FOR THE TYPE-S EXTENSION CONTAINED WARNINGS TO: NOT ALLOW THE PATIENT TO REPOSITION THEMSELVES. ENSURE DEVICE IS SECURE PRIOR TO USE. NO ADDITIONAL ACTION PLANNED. DEVICE NOT USED AS INTENDED. REPLACEMENT PARTS SENT TO DISTRIBUTOR TO ENSURE A PROPER FIT.