BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARRHYTHMIA DETECTOR AND ALARM

    MDR report key: 2619190 · Received April 21, 2009

    Report

    Report Number
    3004946833-2009-00001
    Event Type
    Malfunction
    Date Received
    April 21, 2009
    Date of Event
    March 20, 2009
    Report Date
    April 15, 2009
    Manufacturer
    CARDIONET, INC
    Product Code
    DSI
    PMA / PMN Number
    K063222
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    CARDIONET MONITOR SERIAL NUMBER (B)(4) WAS AT (B)(4) DISTRIBUTION CENTER. THE MONITOR WAS SITTING ON A MOBILE WIRE RACK/SHELF IN THE OFF POSITION WHEN SMOKE WAS OBSERVED TO BE COMING OUT OF THE DEVICE. HEAT COMING FROM THE SMOKING DEVICE PARTIALLY MELTED THE PLASTIC CASE OF THE DEVICE. THE MONITOR WAS NOT IN-SERVICE, ON A PATIENT OR CHARGING AT THE TIME OF THIS EVENT. NO ONE AT THE DISTRIBUTION CENTER WAS INJURED AND NO DAMAGE TO THE FACILITY OCCURRED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARRHYTHMIA DETECTOR AND ALARM ECG MONITOR WITH ARRHYTHMIA DETECTION DSI CARDIONET, INC CN1004 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other