Description of Event or Problem · 1
45M ADMITTED FOR PNEUMONIA/EMPYEMA HAD A CARDIAC ARREST W/ ASSYSTOLE. EXTERNAL PACEMAKER PRODUCED A CAPTURE RHYTHM AND BP. DURING TRANSPORT TO ICU, THE UNIT CEASED FUNCTIONING W/O ADEQUATE WARNING. THE PATIENT DID NOT SURVIVE THE SUBSEQUENT RESUSCITATION PROCEDURE. AFTER CASE ANALYSIS, IT WAS CONCLUDED THAT THE FAILURE OF THE EXT. PACEMAKER DID NOT MATERIALLY AFFECT THE OUTCOME. AN INDEPENDENT BIOMEDICAL ENGINEER DETERMINED THAT THE UNIT'S BATTERY HAD FAILED. SFW WORKED WITH THE MANUFACTURER; THE FOLLOWING STEPS HAVE OR WILL BE IMPLEMENTED: 1) BATTERY EXCHANGE PROGRAM; 2) OBTAINED A BATTERY TESTING DEVICE; 3) ZOLL IS DEVELOPING A TESTING PROCEDURE FOR THE BATTERIES; 4) STAFF EDUCATION ON THE LIMITATIONS OF THE DEVICE FOR TRANSPORT; 5) OBTAINED AND IMPLEMENTED A TRANSPORT DEFIBRILLATOR/EXT PACEMAKERDEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-JUL-92. SERVICE PROVIDED BY: INVALID DATA. SERVICE RECORDS AVAILABLE.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, COMPUTER HARDWARE PERFORMANCE TESTS CONDUCTED, COMPUTER SOFTWARE PERFORMANCE TESTS CONDUCTED, ELECTRICAL TESTS PERFORMED, MECHANICAL TESTS PERFORMED, PERFORMANCE TESTS PERFORMED, VISUAL EXAMINATION. RESULTS OF EVALUATION: COMPONENT FAILURE, COMPUTER HARDWARE PROBLEM, DESIGN - INADEQUATE, END OF LIFE - PREMATURE. CONCLUSION: DEVICE FAILURE OCCURRED BUT NOT RELATED TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE TEMPORARILY REMOVED FROM SERVICE, DEVICE USE CONTINUED WITH RESTRICTIONS/LIMITATIONS, USER EDUCATION PROVIDED, INSERVICED BY BIOMEDICAL ENGINEERING DEPT. STAFF. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.