BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    MDR report key: 2820236 · Received October 11, 2012

    Report

    Report Number
    3003793491-2012-00324
    Event Type
    Malfunction
    Date Received
    October 11, 2012
    Date of Event
    September 12, 2012
    Report Date
    September 13, 2012
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED COMPLAINT OF "USER ADVISORY 134" (ENCODER FAILURE) WAS VERIFIED. THE ENCODER WAS FOUND TO BE DEFECTIVE. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE DISPLAYED A USER ADVISORY 134 ERROR MESSAGE. NO ADVERSE EVENT REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other