BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    MDR report key: 3058434 · Received March 21, 2013

    Report

    Report Number
    3003793491-2013-00411
    Event Type
    Malfunction
    Date Received
    March 21, 2013
    Date of Event
    February 26, 2013
    Report Date
    February 28, 2013
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORP HAS NOT YET RECEIVED THE DEVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED AND WHEN IT IS EVALUATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PT USE, THE BATTERY SHOWED FULL CHARGE, BUT THE PLATFORM AFTER 5 OR 6 COMPRESSIONS, STOPPED AND SHUT DOWN. THE PLATFORM STARTED UP IMMEDIATELY WHEN POWER BUTTON WAS PUSHED AND AGAIN IT SHUT DOWN AFTER 5 OR 6 COMPRESSIONS. BATTERY WAS REPLACED, BUT THE PLATFORM SHUT DOWN AGAIN. COMPRESSIONS WERE CONTINUED MANUALLY AND PT CARE WAS NOT AFFECTED. DATE ON THE BATTERIES IS 04/2012. NO ADVERSE PT SEQUELAE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116910 AUTOPULSE RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC 100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other MANUAL COMPRESSION