BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACT I

    MDR report key: 2150719 · Received June 22, 2011

    Report

    Report Number
    3027765-2011-00025
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Date of Event
    February 25, 2011
    Report Date
    June 22, 2011
    Manufacturer
    LIFEWATCH SERVICES, INC.
    Product Code
    DSI
    PMA / PMN Number
    K101639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY, DEVICE #2 FULL QC TESTING: FAIL (OVERCURRENT). VISUAL PCB INSPECTION: FAIL (CORROSION: U1, U10, C58, C56). CABLE ELECTRICAL INSPECTION CONTINUITY ON ALL CHANNELS: PASS. CABLE ELECTRICAL INSPECTION FOR NO SHORT ON ALL CHANNELS: PASS. CABLE VISUAL INSPECTION OF CABLE: PASS. CABLE VISUAL INSPECTION OF YOKE: PASS. LEAKAGE CURRENT: PASS. SENSOR TEMPERATURE INCREASE: FAIL. THE OVERCURRENT AND TEMPERATURE INCREASE FAILURES ARE CORRELATED. OVERCURRENT FAILURE IN THE TEST STATION IMPLIES THAT THE SENSOR'S CURRENT CONSUMPTION WAS BEYOND THE TESTING THRESHOLDS. THE SENSOR FAILED AS THE CURRENT CONSUMPTION IN NORMAL OPERATION WAS 93.5MA INSTEAD OF 80MA. (B)(4). A FAILURE IN THE DECOUPLING CAPACITORS (AS OBSERVED IN THE VISUAL INSPECTION) WILL CAUSE EXCESS CURRENT CONSUMPTION OF THE DEVICE. EXCESS CURRENT CONSUMPTION WILL CAUSE THE BATTERY TO HEAT UP, THUS THE SENSOR'S TEMPERATURE INCREASED BY 3.5 DEGREE C. ALTHOUGH, THE PT FELT THE SENSOR OVERHEAT, IT POSED NO SAFETY HAZARD AS WHEN THE SENSOR IS EXPOSED TO THE MAXIMUM AMBIENT TEMPERATURE OF 37 DEGREE C A TEMPERATURE INCREASE OF 2.9 DEGREE C WILL BRING THE SENSOR'S TEMPERATURE TO LESS THAN 43 DEGREE C. THIS IS BELOW THE THRESHOLD THAT APPLICABLE LITERATURE ESTABLISHES AS WHAT WOULD CAUSE BURN. ASSOCIATED ACCESSORY DEVICE: MODEL #COM001 SERIAL # (B)(4).

    Description of Event or Problem · 1

    THIS MDR IS BEING FILED IN RESPONSE TO THE PT'S REPORT THAT HE RECEIVED TWO ACT SENSORS AND BOTH SENSOR BATTERIES OVERHEATED. THE PT DID NOT REPORT ANY INJURY OR BURN. THESE DEVICES WILL BE REFERRED TO AS DEVICE #1 SERIAL NUMBER (B)(4) AND DEVICE #2 SERIAL NUMBER (B)(4). A THIRD DEVICE WAS SENT TO THE PT AND NO ISSUES WERE NOTED. LIFEWATCH PERFORMED PRELIMINARY TESTING ON DEVICE #1 AND DEVICE #2 ON (B)(6) 2011. BASED ON THOSE RESULTS, THE DEVICES WERE SENT TO (B)(4) FOR FULL DEVICE INTERROGATION ON (B)(4) 2011. (B)(4) RESULTS OF ENGINEERING INVESTIGATION WERE RECEIVED ON (B)(4) 2011 AND REVEALED THAT DEVICE #1 PASSED ALL FUNCTIONAL TESTING, BUT DEVICE #2 HAD FAILURE MODES THAT MUST BE REPORTED. ALL TEST RESULTS REPORTED IN THIS FORM ARE REFLECTIVE OF DEVICE #2.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other