BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    MDR report key: 3111970 · Received April 29, 2013

    Report

    Report Number
    3003793491-2013-00495
    Event Type
    Malfunction
    Date Received
    April 29, 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
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE AUTOPULSE DEVICE WAS NOT RETURNED TO ZOLL CIRCULATION FOR INVESTIGATION, THEREFORE NO SUPPLEMENTAL REPORT WILL BE SUBMITTED. NOTE: MFR 3003793491-2013-00491 ADDRESSES THE SECOND CARDIAC PT. MFR 3003793491-2013-00495 ADDRESSES THE FIRST CARDIAC PT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE AUTOPULSE PLATFORM ENCOUNTERED PROBLEMS ON TWO PREVIOUS CARDIAC ARRESTS. IT WAS ALSO REPORTED THAT THE AUTOPULSE DEVICE EXPERIENCED MULTIPLE USER ADVISORY MESSAGES, HOWEVER IT IS UNK WHICH ONES THE DEVICE DISPLAYED. NO ADVERSE PT SEQUELAE WAS REPORTED. ADDITIONAL DETAILS WERE REQUESTED BY MANUFACTURER HOWEVER NONE WERE ABLE TO BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183464 AUTOPULSE RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC. 100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other