Description of Event or Problem · 1
A WHEELCHAIR BACK AND CUSHION AND A WHEELCHAIR SEAT AND CUSHION WERE APPLIED TO ONE OF THE FACILITY'S WHEELCHAIRS FOR SOLE USE FOR THIS RESIDENT. THE EQUIPMENT WAS USED FOR APPROX ONE MONTH. APPLICATION WAS COMPLETED BY REPRESENTATIVE (REHABILITATION CONSULTANT) FROM THE DISTRIBUTOR. ON 6/7/95 RESIDENT WAS FOUND LYING ON HER BACK WITH HER HEAD AGAINST A CLOSET DOOR AND HER LOWER LEGS RESTING ON THE WHEELCHAIR SEAT. THE BACK WAS OFF THE CHAIR AND THE RESIDENT HAD FALLEN BACKWARD. NURSING STAFF IMMEDIATELY ASSESSED FOR INJURIES AND INITIATED NEURO-CHECKS AS RESIDENT STATED SHE BUMPED HER HEAD. NO CONTUSIONS, ABRASIONS, OR LACERATIONS WERE NOTED AT THIS TIME. PHYSICIAN WAS NOTIFIED ON THE INCIDENT. ON VISUAL INSPECTION OF THE WHEELCHAIR BY THE SAFETY SURVEILLANCE NURSE IT WAS NOTED THE LOWER BRACKETS APPLIED DIRECTLY TO THE WHEELCHAIR FOR THE BACK WERE STILL IN PLACE AND TIGHT. THE EQUIPMENT WAS IMMEDIATELY REMOVED FROM THE FACILITY'S WHEELCHAIR AND THE ORIGINAL BACK WAS REINSTALLED. DIST NOTIFIED BY TELEPHONE ON 6/7/95. DIST WILL PICK UP THE EQUIPMENT FOR EVALUATION. NO ADVERSE EFFECTS TO THE RESIDENT HAVE BEEN NOTED TO THIS DATE.DEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE NOT SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.DEVICE WAS NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.