BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPLUSE RESUSCITATION SYSTEM MODEL 100

    MDR report key: 2953875 · Received January 11, 2013

    Report

    Report Number
    3003793491-2013-00093
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    October 10, 2012
    Report Date
    December 13, 2012
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORP HAS NOT YET RECEIVED THE DEVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE IS RECEIVED AND EVALUATED. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING DEPLOYMENT, THE LIFEBAND GOT LOOSE AND THE CUSTOMER WAS NOT ABLE TO USE THE PLATFORM. MANUAL CPR WAS PERFORMED BEFORE THE LIFEBAND WAS RE-ADJUSTED FOR USE. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17510 AUTOPLUSE RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC. 100

    Patients

    Seq Age Sex Outcome Treatment
    1 Other