BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARRHYTHMIA DETECTOR AND ALARM

    MDR report key: 1503412 · Received September 29, 2009

    Report

    Report Number
    3004946833-2009-00002
    Event Type
    Malfunction
    Date Received
    September 29, 2009
    Date of Event
    August 31, 2009
    Report Date
    September 29, 2009
    Manufacturer
    CARDIONET, INC
    Product Code
    DSI
    PMA / PMN Number
    K063222
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS STILL UNDERWAY AT THE PRESENT TIME. ONCE COMPLETED, A FOLLOW-UP REPORT WILL BE SENT, WHICH MAY CONTAIN DIFFERENT RESULTS AND CONCLUSIONS.

    Description of Event or Problem · 1

    CARDIONET MONITOR SERIAL NUMBER (B)(4) WAS IN THE PATIENT'S POCKETBOOK, WHILE THE PATIENT WAS AT PHYSICAL THERAPY. THE PATIENT AND THERAPIST WERE ABOUT 10 FEET AWAY FROM THE POCKETBOOK WHEN THE THERAPIST NOTICED SMOKE COMING OUT OF THE POCKETBOOK. NO ACTUAL FLAMES WERE REPORTED. THE PATIENT STATED SHE DID NOT HEAR ANY BEEPING COMING FROM THE DEVICE AND THERE WAS NOTHING FLAMMABLE IN HER PURSE, E.G., LIGHTERS, MATCHES OR CIGARETTES. NOTHING ELSE IN THE PATIENT'S POCKETBOOK WAS DAMAGED BESIDES THE MONITOR, WHICH WAS PARTIALLY MELTED. THE MONITOR WAS NOT CHARGING OR PLACED IN DIRECT SUN/HEAT PRIOR TO WHEN THE EVENT OCCURRED. NO ONE (THE PATIENT OR THERAPIST) 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 DSI CARDIONET, INC CN1004 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other