BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    MDR report key: 3111972 · Received April 30, 2013

    Report

    Report Number
    3003793491-2013-00498
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 2, 2013
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    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

    THE CUSTOMER REPORTED THAT WHILE TRAINING ON MANIKINS, A VERY OLD AUTOPULSE DISPLAYED SEVERAL ERROR MESSAGES. THERE WAS NOT PT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188841 AUTOPULSE RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC. 100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA