BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    MDR report key: 2881048 · Received November 9, 2012

    Report

    Report Number
    3003793491-2012-00276
    Event Type
    Malfunction
    Date Received
    November 9, 2012
    Date of Event
    October 10, 2012
    Report Date
    October 10, 2012
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED COMPLAINT OF "THE BOARD DISPLAYED USER ADVISORY 45 (NOT AT HOME POSITION AFTER POWER-ON/RESET) AND THE SHAFT WAS NOT AT THE HOME POSITION" WAS NOT CONFIRMED. FURTHERMORE, NO PROBLEMS WERE FOUND IN THE ARCHIVE FILE. THE BOARD SHOWED SIGNS OF PHYSICAL DAMAGE CONSISTENT WITH HAVING BEEN DROPPED. THE TOP COVER, MOTOR COVER, ENCODER COVER, HEAD RESTRAINTS AND BATTERY COMPARTMENT, WHICH WERE DAMAGED, WERE REPLACED. A MISSING PATIENT PIN WAS ALSO REPLACED. THE BOARD WAS RUN WITH THE TEST MANIKIN AND THE LARGE RESUSCITATION TEST FIXTURE (EQUAL TO A (B)(6) PATIENT), NO PROBLEMS WERE OBSERVED. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BOARD DISPLAYED USER ADVISORY 45 AND THAT THE SHAFT WAS NOT AT THE HOME POSITION. IT WAS ALSO REPORTED THAT BOTH OF THE HEAD HARNESS BARS HAD BEEN REMOVED. NO ADVERSE EVENT REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other