BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    MDR report key: 2943499 · Received January 9, 2013

    Report

    Report Number
    3003793491-2012-00602
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    December 11, 2012
    Report Date
    December 11, 2012
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION HAS RECEIVED THE PRODUCT AND WILL BE PROVIDING A SUPPLEMENTAL REPORT WHEN OUR INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ON SITE VISIT, AN AUTOPULSE RESUSCITATION SYSTEM WITH S/N (B)(4) DISPLAYED A USER ADVISORY MESSAGE OF UA45 (NOT AT "HOME" POSITION AFTER POWER-ON/RESTART. USER ADVISORY WAS ABLE TO BE CLEARED ON SITE. IT WAS ALSO REPORTED THAT BOARD KEEPS SHUTTING OFF, RUNNING FOR ONLY TWO MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11280 AUTOPULSE RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC. MODEL 100

    Patients

    Seq Age Sex Outcome Treatment
    1 Other