BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    MDR report key: 3060668 · Received March 26, 2013

    Report

    Report Number
    3003793491-2013-00329
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    February 27, 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 Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED COMPLAINT OF "PLATFORM WOULD NOT POWER UP" WAS NOT VERIFIED. CUSTOMER INDICATED THAT NO ERROR MESSAGE WAS DISPLAYED, WHICH IS AN INDICATION OF THE SYSTEM HAVING POWERED ON. IT IS LIKELY THAT THE SYSTEM WAS POWERING ON, BUT THE LIFEBAND WAS NOT CONTRACTING. PLATFORM DID POWER UP; NO ISSUES WERE OBSERVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE ATTEMPTING TO USE THE AUTOPULSE ON A PT, THE PLATFORM WOULD NOT POWER ON. A GOOD BATTERY WAS PLACED INTO THE PLATFORM, BUT THE PLATFORM WOULD NOT POWER ON AND NO ERROR MESSAGE WAS DISPLAYED. ANOTHER AUTOPULSE WAS USED SUCCESSFULLY TO PERFORM CPR. NO PT SEQUELA WAS REPORTED. BIOMED CHECKED THE PLATFORM ON-SITE. WHEN HE PRESSED THE GREEN BUTTON, THE UNIT STARTED TO WORK. THE DEVICE POWERED ON AND THE ISSUE COULD NOT BE DUPLICATED. THERE WAS NO PT INVOLVEMENT AS THEY WERE UNABLE TO POWER ON THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123161 AUTOPULSE RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC 100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other