BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACT I SENSOR

    MDR report key: 2180699 · Received May 5, 2011

    Report

    Report Number
    3027765-2011-00017
    Event Type
    Malfunction
    Date Received
    May 5, 2011
    Date of Event
    April 6, 2011
    Report Date
    April 6, 2011
    Manufacturer
    LIFEWATCH SERVICES, INC.
    Product Code
    DSI
    PMA / PMN Number
    K101639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRELIMINARY TESTING WAS PERFORMED BY LIFEWATCH: VISUAL INSPECTION UPON RECEIPT: NO DISCREPANCIES. SENSOR LONG TEST: FAILED (DID NOT CONNECT). SIMULATOR TESTING: FAILED (DID NOT CONNECT). BATTERY VOLTAGE: PASS. LEAD WIRE TEST/VISUAL INSPECTION: PASS. THERMAL TEST: FAIL (SENSOR BATTERY COVER TEMPERATURE VALUE=117 DEGREES FAHRENHEIT (UPPER LIMIT=109 DEGREES FAHRENHEIT). UPON OPENING THE DEVICE, IT APPEARS THERE IS WATER DAMAGE, CAUSING CORROSION ON THE PCB. THE BLUETOOTH ANTENNA WAS ALSO MISSING. THE SENSOR WILL BE FORWARDED TO THE MFR FOR FURTHER INTERROGATION AND FINAL CONCLUSIONS. ASSOCIATED ACCESSORY DEVICE: ACT MONITOR, MODEL # COM001, SERIAL NUMBER (B)(4).

    Description of Event or Problem · 1

    THIS MDR IS BEING FILED DUE TO SENSOR OVERHEATING. THE PT CALLED CUSTOMER SUPPORT BECAUSE THE PHONE AND SENSOR WERE NOT COMMUNICATING. CUSTOMER SUPPORT ASKED THE PT TO REMOVE THE SENSOR BATTERY AS PART OF TROUBLESHOOTING, AND SHE REPORTED THE BATTERY WAS HOT TO THE TOUCH. NO INJURY WAS INCURRED. CUSTOMER SUPPORT ADVISED THE PT TO EXPLANT THE DEVICE AND RETURN IT FOR EVAL. A REPLACEMENT DEVICE WAS ORDERED. UPON INTERROGATION, IT WAS NOTED THAT THE SENSOR BATTERY COVER REACHED 117 DEGREES FAHRENHEIT (UPPER LIMIT=109 DEGREES FAHRENHEIT). ALTHOUGH THERE WAS NO PT INJURY, AN MDR IS BEING FILED AS A CONSERVATIVE MEASURE SINCE THE RECORDED TEMPERATURE EXCEEDED SPECIFICATIONS. CONSEQUENTLY, THERE IS POTENTIAL FOR BIOLOGICAL HARM. A TELEPHONE INTERVIEW WITH THE PT ON (B)(6) 2011 REVEALED THE EVENT OCCURRED AFTER TWO DAYS OF USING THE DEVICE. SHE REPORTED THAT ON THE FIRST NIGHT OF USE, SHE HAD THE DEVICE IN THE BATHROOM WITH HER WHILE SHE SHOWERED (WHICH IS CONTRA INDICATED IN THE PT USER GUIDE, AS THE DEVICE IS NOT WATER RESISTANT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACT I SENSOR DETECTOR AND ALARM, ARRHYTHMIA DSI LIFEWATCH SERVICES, INC. DEV059 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Other