BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPLUSE RESUSCITATION SYSTEM MODEL 100

    MDR report key: 3100031 · Received April 27, 2013

    Report

    Report Number
    3003793491-2013-00482
    Event Type
    Malfunction
    Date Received
    April 27, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 1, 2013
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION HAS NOT YET REC'D THE DEVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS REC'D.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE AUTOPULSE DEVICE DISPLAYED A USER ADVISORY MESSAGE OF UA 42 (FORCE OVERLOAD TRIPPED). ADD'L DETAILS WERE REQUESTED BY THE MFR AND HAVE NOT BEEN OBTAINED. IT IS UNK IF DEVICE WAS USED ON A PT. NO ADVERSE PT SEQUELAE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183257 AUTOPLUSE RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC. MODEL 100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other