BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACT III SENSOR

    MDR report key: 2150718 · Received June 22, 2011

    Report

    Report Number
    3027765-2011-00023
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Date of Event
    May 16, 2011
    Report Date
    May 23, 2011
    Manufacturer
    LIFEWATCH SERVICES, INC.
    Product Code
    DSI
    PMA / PMN Number
    K110499
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED BY LIFEWATCH ON (B)(4) 2011, AND DEVICE TESTING IS STILL ONGOING. UPON COMPLETION OF PRELIMINARY TESTING, THE DEVICE WILL BE SHIPPED TO THE MFR FOR FURTHER EVALUATION. ASSOCIATED ACCESSORY FOR DEVICE: ACT CELL PHONE MONITOR; MODEL # COM001; (B)(4).

    Description of Event or Problem · 1

    THIS MDR IS BEING FILED IN RESPONSE TO THE PT'S REPORT THAT THE ELECTRODE GEL STARTED LEAKING AND THE METAL SNAP UNDER THE RED AND BLACK ELECTRODES MADE CONTACT WITH HER SKIN AND CAUSED BURNS. THE RED ELECTRODE BURN OCCURRED APPROX ON (B)(6) 2011. THE BLACK ELECTRODE BURN OCCURRED ON (B)(6) 2011. NO MEDICAL INTERVENTION WAS REQUIRED NOR WAS MEDICATION USED FOR TREATMENT. THE RED ELECTRODE BURN WAS DESCRIBED AS LOOKING LIKE A THIN LINE BUT DEEP (VERTICAL). IT WAS HEALED BY (B)(6) 2011 WHEN THE PT WAS INTERVIEWED. THE BLACK ELECTRODE BURN WAS DESCRIBED AS A HORIZONTAL LINE. THE BURNS DID NOT BLEED. THE PT REPORTED NO OVERHEATING OF THE DEVICE. THE PT DID NOT OBSERVE ANYTHING UNUSUAL CONCERNING THE DEVICE. THE PT STARTED SERVICE ON (B)(6) 2011.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other ORAL CONTRACEPTIVE (UNSPECIFIED)