BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    MDR report key: 2971949 · Received January 21, 2013

    Report

    Report Number
    3003793491-2013-00123
    Event Type
    Malfunction
    Date Received
    January 21, 2013
    Date of Event
    February 9, 2012
    Report Date
    February 24, 2012
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION HAS NOT YET RECEIVED THE DEVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED AND WHEN IT IS EVALUATED. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE AUTOPULSE WORKED FOR ABOUT 5 MINUTES AND STOPPED (AFTER DEFIBRILLATION) AND INDICATED "REPLACE BATTERY". LATER, USING A TEST MANIKIN, TWICE THE AUTOPULSE INDICATED "ALIGN PATIENT ON PLATFORM CLOSE LIFEBAND AND PRESS START TO CONTINUE". IT THEN WORKED FOR 1.5 MINUTES AND INDICATED "PULL UP LIFEBAND AND PRESS RESTART". USER ADVISORY 17 (MAX MOTOR ON TIME EXCEEDED DURING ACTIVE OPERATION) WAS THEN INDICATED. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28933 AUTOPULSE RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC. MODEL 100

    Patients

    Seq Age Sex Outcome Treatment
    1 Other