Description of Event or Problem · 1
PATIENT WAS ADMITTED TO HOSPITAL I.C.U. ON JULY 12, 1993 AND HAD A CARDIAC PULMONARY ARREST. THE PATIENT WAS SUCCESSFULLY RESUSCITATED AND PLACED ON CMV OF 14. APPROVXIMATELY TEN MINUTES LATER, THE PATIENT WAS APPEIC AND VENTILATOR WAS FOUND TO BE IN A CPAP MODE. THE PATIENT WAS SUCCESSFULLY MANUALLY VENTILATED WHILE A REPLACEMENT VENTILATOR WAS OBTAINED. THE PATIENT HAD NO FURTHER EVENT ON THE VENTILATOR. HOWEVER, 8 HOURS AFTER THE EVENT, THE PATIENT EXPIRED. IMPRESSION: THE FINDINGS SUGGEST THE PATIENT ALLEGED EQUIPMENT MALFUNCTION DID NOT CONTRIBUTE TO THE PATIENT'S DEMISE. THE MEDICAL EXAMINER WAS CALLED AND REFUSED THE CASEDEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: CRITICAL CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: . SERVICE PROVIDED BY: DISTRIBUTOR. SERVICE RECORDS AVAILABLE.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: ALARM. CONCLUSION: DEVICE EVALUATED AND ALLEGED FAILURE COULD NOT BE DUPLICATED. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE TEMPORARILY REMOVED FROM SERVICE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.