BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACT 3 SENSOR

    MDR report key: 1864831 · Received September 28, 2010

    Report

    Report Number
    3027765-2010-00083
    Event Type
    Malfunction
    Date Received
    September 28, 2010
    Date of Event
    August 30, 2010
    Report Date
    September 1, 2010
    Manufacturer
    LIFEWATCH SERVICES, INC.
    Product Code
    DSI
    PMA / PMN Number
    K081257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS RETURNED ON (B)(4) 2100 AND IN HOUSE PRELIMINARY TESTING HAS NOT BEEN PERFORMED.

    Description of Event or Problem · 1

    A REPLACEMENT DEVICE WAS SENT TO THE PATIENT BECAUSE THE PATIENT STATED THAT SHE FELT A SHOCK FROM THE ELECTRODES. ON (B)(6) 2010 LIFEWATCH CONTACTED THE PATIENT AND A QUESTIONNAIRE WAS FILLED OUT. THE PATIENT STATED THAT SHE WAS SITTING IN CLASS AND FELT A SHOCK FROM THE RED ELECTRODE THAT JUMPED TO THE WHITE ELECTRODE.

    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 22 YR Other ACT MONITOR: MODEL #COM001, (B)(4)