Description of Event or Problem · 1
PT WAS IN EXTREMELY CRITICAL CONDITION AFTER STATUS POST MULTIPLE TRAUMA & CARDIAC ARREST IMMEDIATELY POST OP. RESUSCITATION INCLUDED OPENING THE CHEST FOR HEART MASSAGE & TO ASSESS FOR CARDIAC TAMPONADE. THE RIB RETRACTOR WAS USED AS A CONVENIENCE TO SEPARATE DURING SURGERY. DURING THIS PROCEDURE, THE RIB RETRACTOR GEAR MECHANISM FROZE & COULD NOT BE ADJUSTED. THE RIB RETRACTOR WAS REMOVED WITHOUT INTERRUPTION OF RESUSCITATION EFFORTS, & THE RIBS WERE EASILY SEPARATED MANUALLY. THE RIB RETRACTOR WAS IN THIS INSTANCE, NON-ESSENTIAL & WAS NOT A CONTRIBUTING FACTOR IN THE PT'S SUBSEQUENT UNSUCCESSFUL RESUSCITATION.DEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: CRITICAL 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, MECHANICAL TESTS PERFORMED, PERFORMANCE TESTS PERFORMED, VISUAL EXAMINATION. RESULTS OF EVALUATION: FOREIGN MATERIAL CONTAMINATION, INSUFFICIENT LUBRICATION, MATERIAL DEGRADATION/DETERIORATION, MECHANICAL PROBLEM. CONCLUSION: DEVICE FAILURE OCCURRED BUT NOT RELATED TO EVENT, DEVICE WAS OUT OF SPEC BUT THIS DOES NOT RELATE TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: NO. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE, INSERVICED BY MANUFACTURER/DISTRIBUTOR REPRESENTATIVE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.