TRAPEZE

Description of Event or Problem

TRAPEZE DEVICE BROKE AND FELL ON PT'S HEAD. NO LOSS OF CONSCIOUSNESS, NO FRACTURE. SCALP LACERATION REQUIRING SUTURES. MILD SWELLING AND ERYTHEMA UNDER LEFT EYE. PT WAS POSTOPERATIVE RIGHT HIP FRACTURE. METAL EQUIPMENT ATTACHED PROPERLY. IT BROKE IN TWO. DIALOGUE WITH MFR TAKING PLACE TO ASCERTAIN CONDITION OF OTHER 18 DEVICES. IDENTIFICATION OF PURCHASE DATE IN PROCESS WITH MFG. PART OF DEVICE RETURNED TO MFR.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION. RESULTS OF EVALUATION: OTHER. CONCLUSION: DEVICE FAILURE DIRECTLY CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.