BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACT 3 SENSOR

    MDR report key: 1920641 · Received October 20, 2010

    Report

    Report Number
    3027765-2010-00088
    Event Type
    Malfunction
    Date Received
    October 20, 2010
    Date of Event
    September 9, 2010
    Report Date
    September 20, 2010
    Manufacturer
    LIFEWATCH SERVICES, INC.
    Product Code
    DSI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ASSOCIATED ACCESSORY DEVICE: ACT MONITOR, MODEL# COM001, SERIAL# (B)(4).

    Description of Event or Problem · 1

    A PAUSE WAS FOUND IN WHICH THE DEVICE DID NOT CAPTURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1