BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUMPER

    MDR report key: 759694 · Received October 20, 2005

    Report

    Report Number
    1821850-2005-00031
    Event Type
    Malfunction
    Date Received
    October 20, 2005
    Date of Event
    September 19, 2005
    Report Date
    October 19, 2005
    Manufacturer
    MICHIGAN INSTRUMENTS
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF 10/19/2005, DEVICE HAS NOT BEEN RETURNED FOR EVALUATION, BUT IS ANTICIPATED. UPON EVALUATION OF THE UNIT, FOLLOW UP REPORT WITH EVALUATION FINDINGS WILL BE SUBMITTED.

    Description of Event or Problem · 1

    UNIT REPORTED CYCLING AT 60 CPM AND WAS ONLY ADJUSTABLE TO A MAXIMUM RATE OF 70-80 CPM NOT 100 CPM AS ORIGINALLY CONFIGURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THUMPER CARDIOPULMONARY RESUSCITATOR DRM MICHIGAN INSTRUMENTS 1007 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN