BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE RESUSCITATION SYTEM MODEL 100

    MDR report key: 2982313 · Received January 25, 2013

    Report

    Report Number
    3003793491-2013-00228
    Event Type
    Malfunction
    Date Received
    January 25, 2013
    Date of Event
    December 31, 2012
    Report Date
    December 31, 2012
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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 RECEIVED AND WHEN IT IS EVALUATED. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE AUTOPULSE DISPLAYED USER ADVISORY 12 (LIFEBAND NOT PRESENT). HOWEVER, IT APPEARED THAT THE LIFEBAND WAS CORRECTLY INSTALLED. THREE LIFEBANDS WERE TRIED WITH THE SAME RESULTS. NO ADVERSE EVENTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36502 AUTOPULSE RESUSCITATION SYTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC. MODEL 100

    Patients

    Seq Age Sex Outcome Treatment
    1 Other