BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE TRAINING LIFEBAND

    MDR report key: 2934111 · Received December 21, 2012

    Report

    Report Number
    3003793491-2012-00582
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    November 13, 2012
    Report Date
    November 27, 2012
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION HAS REC'D THE DEVICE ASSOCIATED WITH THIS REPORT. HOWEVER, THE DEVICE IS STILL UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE IS REC'D AND EVALUATED. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE A WHILE TRANSPORTING THE PT, THE PLATFORM DISPLAYED USER ADVISORY 7. MANUAL CPR WAS INITIATED. THE CUSTOMER WAS ABLE TO REPLICATE THE FAILURE AFTER THE INCIDENT. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOPULSE TRAINING LIFEBAND TRAINING LIFEBAND DRM ZOLL CIRCULATION, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other