BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACT I SENSOR

    MDR report key: 1943711 · Received December 15, 2010

    Report

    Report Number
    3027765-2010-00090
    Event Type
    Other
    Date Received
    December 15, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 20, 2010
    Manufacturer
    LIFEWATCH SERVICES, INC.
    Product Code
    DSI
    PMA / PMN Number
    K071995
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS CURRENTLY UNDERGOING PRELIMINARY IN-HOUSE TESTING. IT WILL BE SHIPPED TO THE MFR, CARDGUARD, UPON COMPLETION. ASSOCIATED ACCESSORY DEVICE: ACT MONITOR. MODEL # COM001. SERIAL # (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE PT CALLED TO REPORT HER SKIN IS HAVING A REACTION TO THE ELECTRODES. SHE REPORTED HER SKIN WAS BLISTERING. ATTEMPTS AT COMMUNICATION ON (B)(6) 2010 WERE UNSUCCESSFUL. COMMUNICATION WAS ESTABLISHED ON (B)(6) 2010, AND THE PT WAS INTERVIEWED. THE PT REPORTED SHE WAS USING MEDITRACE ELECTRODES. SHE PREPARED HER SKIN BY CLEANSING WITH SOAP AND WATER PRIOR TO ELECTRODE PLACEMENT. SHE REPORTED CHANGING THE ELECTRODES EVERY 3 DAYS, AND REMOVING THEM PRIOR TO SHOWERING/BATHING BY GENTLY TUGGING WITHOUT WARM WATER. SHE REPORTED REPLACING THE ELECTRODES ON TOP OF THE SAME LOCATION. THE PT REPORTED SHE HAD BLISTER AND SCARS THE SIZE OF THE ELECTRODES UNDER THE RED AND BLACK ELECTRODES. THE AREA UNDER THE OTHER ELECTRODES WAS RED, BUT NO BLISTERS DEVELOPED. AT THE TIME OF THE INTERVIEW, THE PT REPORTED THE IRRITATION WAS HEALED WITH SCARS STILL PRESENT. THE PT WAS SEEN BY HER PRIMARY CARE PHYSICIAN AND WAS PRESCRIBED BACITRACIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACT I SENSOR DETECTOR AND ALARM, ARRHYTHMIA DSI LIFEWATCH SERVICES, INC. DEV059 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other