BEUDAMED
    FDA Adverse Event Death Summary report: N

    AUTOPULSE® RESUSCITATION SYSTEM MODEL 100

    MDR report key: 3668507 · Received March 7, 2014

    Report

    Report Number
    3003793491-2014-00123
    Event Type
    Death
    Date Received
    March 7, 2014
    Date of Event
    February 8, 2014
    Report Date
    February 10, 2014
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS FOR THE RETURNED PLATFORM AS FOLLOWS: VISUAL INSPECTION OF THE RETURNED PLATFORM SHOWS NO DAMAGE. A REVIEW OF THE ARCHIVE WAS PERFORMED AND THE REPORTED COMPLAINT OF THE PLATFORM DISPLAYING A "SYSTEM ERROR - OUT OF SERVICE, REVERT TO MANUAL CPR" MESSAGE WAS CONFIRMED. THE ARCHIVE DATA SHOWS THAT SYSTEM ERROR 132 (INTERNAL WATCHDOG TIMEOUT) OCCURRED MULTIPLE TIMES ON THE REPORTED EVENT DATE OF (B)(6) 2014. FUNCTIONAL TESTING WAS PERFORMED AND THE REPORTED ISSUE WAS OBSERVED. UPON POWER UP OF THE PLATFORM, A "SYSTEM ERROR - OUT OF SERVICE, REVERT TO MANUAL CPR" MESSAGE WAS DISPLAYED. THE ERROR MESSAGE WAS CLEARED. LOAD CELL CHARACTERIZATION TESTING WAS PERFORMED AND DEMONSTRATED THAT BOTH LOAD CELL MODULES WERE FUNCTIONING WITHIN SPECIFICATIONS. THE PLATFORM WAS ALSO SUBJECTED TO A RUN-IN TEST USING A (B)(6) PATIENT TEST FIXTURE AND GOOD BATTERIES FOR SEVERAL HOURS WITH NO FAULTS OR ERRORS OBSERVED. DUE TO THE OBSERVED "SYSTEM ERROR - OUT OF SERVICE, REVERT TO MANUAL CPR" (SYSTEM ERROR 132), AS A PRECAUTION, THE PART THAT WAS IDENTIFIED FOR REPLACEMENT WAS THE PROCESSOR PCA BOARD. IN SUMMARY, THE REPORTED COMPLAINT OF THE PLATFORM DISPLAYING "SYSTEM ERROR - OUT OF SERVICE" MESSAGE WAS CONFIRMED BASED ON THE ARCHIVE REVIEW AND DURING FUNCTIONAL TESTING. UPON CLEARING THE ERROR MESSAGE AND REPLACEMENT OF THE PROCESSOR PCA BOARD AS A PRE-CAUTION, THE PLATFORM PASSED ALL TESTING CRITERIA. ALTHOUGH IT IS UNKNOWN IF THE PATIENT'S DEATH IS ATTRIBUTED TO THE AUTOPULSE USAGE, ROSC (RETURN OF SPONTANEOUS CIRCULATION) WAS NEVER ACHIEVED WITH EITHER METHODS OF COMPRESSIONS (MANUAL OR MECHANICAL). ADDITIONALLY, EKG TAKEN PRIOR TO AUTOPULSE DEPLOYMENT SHOWED THAT THE PATIENT WAS ASYSTOLIC. SURVIVAL RATES IN A CARDIAC ARREST PATIENT WITH ASYSTOLE ARE EXTREMELY LOW.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IN COMPLAINT WAS RETURNED TO ZOLL ON (B)(4) 2014 FOR INVESTIGATION. HOWEVER, INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE FILED ONCE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    CUSTOMER RECEIVED A CALL REGARDING A (B)(6) YEAR OLD MALE PATIENT, WEIGHING 180 POUNDS WHO WAS EXPERIENCING DIFFICULTY BREATHING. A FAMILY MEMBER WITNESSED THE ARREST, HOWEVER, BYSTANDER CPR WAS NOT PERFORMED. LENGTH OF TIME THAT THE PATIENT WAS DOWN IS UNKNOWN. AN EKG WAS PERFORMED, WHICH INDICATED THAT THE PATIENT WAS IN AN ASYSTOLIC CONDITION. THE AUTOPULSE PLATFORM WAS DEPLOYED WITHOUT ANY ISSUES. THE PLATFORM STOPPED AFTER 15 MINUTES OF COMPRESSIONS AND DISPLAYED A "SYSTEM ERROR - OUT OF SERVICE" MESSAGE. CUSTOMER CHANGED THE BATTERY AND RESTARTED THE PLATFORM BUT THE ISSUE DID NOT RESOLVE. THE CREW CONTINUED WITH MANUAL CPR FOR 30 MINUTES, WHICH INCLUDED TRANSPORTATION TIME TO THE HOSPITAL. RETURN OF SPONTANEOUS CIRCULATION (ROSC) WAS NEVER ACHIEVED. THE HOSPITAL WAS 20 MINUTES FROM WHERE THE INCIDENT OCCURRED. PATIENT CONTINUED TO BE TREATED IN THE EMERGENCY ROOM AND WAS ADMINISTERED MEDICATIONS. HOWEVER, MANUAL COMPRESSIONS WERE NOT PERFORMED BY THE STAFF. THE PATIENT WAS PRONOUNCED DEAD IN THE HOSPITAL BY THE PHYSICIAN. CUSTOMER COULD NOT PROVIDE THE CAUSE OF THE PATIENT'S DEATH AND THE EXACT DATE OF DEATH. IN ADDITION, CUSTOMER DOES NOT KNOW IF AN AUTOPSY WAS PERFORMED OR IF A REPORT IS AVAILABLE. INFORMATION REGARDING PATIENT HISTORY WAS NOT PROVIDED. IN ADDITION, IT IS UNKNOWN IF THE PATIENT'S DEATH IS ATTRIBUTED TO THE AUTOPULSE USAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138252 AUTOPULSE® RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC MODEL 100

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death MANUAL CPR