BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACT 3 SENSOR

    MDR report key: 1812752 · Received August 17, 2010

    Report

    Report Number
    3027765-2010-00073
    Event Type
    Malfunction
    Date Received
    August 17, 2010
    Date of Event
    July 8, 2010
    Report Date
    July 8, 2010
    Manufacturer
    LIFEWATCH SERVICES, INC.
    Product Code
    DSI
    PMA / PMN Number
    K081257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IN HOUSE PRELIMINARY TESTING HAS NOT BEEN PERFORMED.

    Description of Event or Problem · 1

    PT CALLED LIFEWATCH ON (B)(6) 2010 AND STATED THAT THE ELECTRODES WERE GETTING WARM AND MELTING THE GEL. IN ORDER TO GATHER ADDITIONAL INFO ON THE COMPLAINT, THE PT WAS CONTACTED ON 07/20/2010 AND A PT QUESTIONNAIRE WAS FILLED OUT. THE PT STATED THAT AFTER WEARING THE ELECTRODES FOR SEVEN DAYS HER SKIN WAS RED. THE PT DESCRIBED THAT HER SKIN AS BEING ITCHY, WATERY BLISTERS. THE PT WAS SEEN BY A DOCTOR WHO PRESCRIBED TRIAMCINOLONE AND BACTROBAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACT 3 SENSOR DETECTOR AND ALARM, ARRHYTHMIA DSI LIFEWATCH SERVICES, INC. DEV060 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other ACT MONITOR: MODEL# COM001, (B)(4)