BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACT 3 SENSOR

    MDR report key: 1823261 · Received August 25, 2010

    Report

    Report Number
    3027765-2010-00080
    Event Type
    Malfunction
    Date Received
    August 25, 2010
    Date of Event
    June 18, 2010
    Report Date
    August 4, 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

    IN HOUSE PRELIMINARY TESTING HAS NOT BEEN PERFORMED. ASSOCIATED ACCESSORY DEVICE: ACT MONITOR, MODEL # COM001, SERIAL # (B)(4).

    Description of Event or Problem · 1

    A COMPLAINT WAS CREATED ON (B)(6) 2010 BY LIFEWATCH BASED ON THE PT'S STATEMENT THAT HE WAS BURNED BY THE ELECTRODES. IN ORDER TO GATHER INFO ON THE INCIDENT, THE PT WAS CONTACTED ON (B)(6) 2010 AND WAS REACHED ON (B)(6) 2010 AND A PT QUESTIONNAIRE WAS FILLED OUT. THE PT STATED THAT HE WOKE UP ABOUT 3 OR 4 AM WITH A BURNING SENSATION. WHEN HE REMOVED THE ELECTRODES THAT WAS ON THE BOTTOM LEFT HE HAD A BLISTER ON THE BOTTOM PART ON THE PATCH. THE REST OF THE ELECTRODES WERE RED UNDER THE PATCH. PT FEELS THAT THE ELECTRODES BURNED HIS SKIN BECAUSE IT WOKE HIM UP FROM A SOUND SLEEP.

    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 35 YR Other