BEUDAMED
    FDA Adverse Event Death Summary report: N

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    MDR report key: 2834094 · Received November 6, 2012

    Report

    Report Number
    3003793491-2012-00233
    Event Type
    Death
    Date Received
    November 6, 2012
    Date of Event
    July 25, 2012
    Report Date
    July 25, 2012
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED COMPLAINT OF USER ADVISORY 2 (ERROR COMMUNICATING WITH BATTERY CONTROLLER), CANNOT CLEAR WAS CONFIRMED. ARCHIVE FILE SHOWED MULTIPLE USER ADVISORY 2'S AND USER ADVISORY 7'S (DISCREPANCY BETWEEN LOAD 1 AND LOAD 2 TOO LARGE). THE LOAD CELL CHARACTERIZATION TESTING INDICATED THAT THE LOAD CELL MODULE 2 WAS NOT FUNCTIONING PROPERLY, WHICH MAY HAVE CAUSED THESE ADVISORIES. THE SYSTEM ALSO HAD A CRACKED MOTOR COVER AND FAILED THE OPEN CASE SYSTEM TEST. LOAD PLATE COVER, MOTOR COVER AND LOAD CELL MODULE 2 WERE REPLACED. INCIDENT REPORT INDICATES THAT MANUAL CPR WAS ADMINISTERED AFTER SYSTEM STOPPED COMPRESSION, THEREFORE, IT IS NOT LIKELY THAT THE SYSTEM CAUSED OR CONTRIBUTED TO THE PT'S DEATH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: "ERROR CODE 2 CANNOT CLEAR HAPPENED ON PT (B)(6) MALE WHO DID NOT SURVIVE BUT THEY REVERTED TO MANUAL CPR."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death