BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE LIFE BAND

    MDR report key: 1041340 · Received April 25, 2008

    Report

    Report Number
    1041340
    Event Type
    Malfunction
    Date Received
    April 25, 2008
    Date of Event
    April 22, 2008
    Report Date
    April 25, 2008
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AUTOPULSE PLACED BUT WRAPS WOULD NOT STAY SECURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOPULSE LIFE BAND NON-INVASIVE CARDIAC SUPPORT PUMP DRM ZOLL MEDICAL CORPORATION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR NO OTHER THERAPIES| NO OTHER THERAPIES