BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACT 3 SENSOR

    MDR report key: 1881794 · Received October 8, 2010

    Report

    Report Number
    3027765-2010-00086
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Date of Event
    September 10, 2010
    Report Date
    September 10, 2010
    Manufacturer
    LIFEWATCH SERVICES, INC.
    Product Code
    DSI
    PMA / PMN Number
    K081257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IN HOUSE PRELIMINARY TESTING HAS NOT BEEN PERFORMED.

    Description of Event or Problem · 1

    THE PT REPORTED THAT THE GREEN AND BLACK ELECTRODES WERE SHOCKING HER AND THE BLACK ELECTRODE LEFT A BURN MARK ON REMOVAL.

    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 39 YR Other ASSOCIATED ACCESSORY DEVICE: ACT MONITOR| MODEL # COM001, (B)(4)