BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACT 3

    MDR report key: 2066113 · Received March 25, 2011

    Report

    Report Number
    3027765-2011-00010
    Event Type
    Malfunction
    Date Received
    March 25, 2011
    Report Date
    February 25, 2011
    Manufacturer
    LIFEWATCH SERVICES, INC.
    Product Code
    DSI
    PMA / PMN Number
    K081257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE PT REPORTED THAT SHE FELT A ZING/ZAP SHOCK FROM THE GREEN ELECTRODES AND A COUPLE OF HOURS LATER SHE FELT A ZING/ZAP SHOCK FROM THE WHITE ELECTRODES. ALTHOUGH THERE WERE NO LONG TERM INJURY, PHYSICIAN INTERVENTION OR MEDICINE PRESCRIBED, AS MDR IS BEING FILLED OUT AS A CONSERVATIVE MEASURE. THE FOLLOWING INFORMATION WAS OBTAINED VIA A TELEPHONE CONVERSATION HELD WITH THE PT ON (B)(6) 2011. PT WAS NOT 100% SURE BUT SHE FEELS THAT THE ZING/ZAP (HER OWN WORDS FOR THE SHOCK FEELING) CAME FROM THE ELECTRODES. THE ZING/ZAPS WERE SUDDEN, REMAINED STEADY AND INTERMITTENT. THE PT WAS AT WORK SITTING DOWN WHEN THE INCIDENTS OCCURRED. THE PT HAD ON ORGANIC COTTON SHIRT AND PANTS AND LEATHER SHOES DURING THE TIME OF THE INCIDENT. THE PT STATED DURING A LATER INTERVIEW ON (B)(6) 2011 THAT HER SKIN WAS IRRITATED WHILE THE ZING/ZAPS OCCURRED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1