BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPOT VITAL SIGNS LXI

    MDR report key: 3589821 · Received October 25, 2013

    Report

    Report Number
    1316463-2013-00012
    Event Type
    Malfunction
    Date Received
    October 25, 2013
    Date of Event
    September 26, 2013
    Report Date
    September 26, 2013
    Manufacturer
    WELCH ALLYN
    Product Code
    DXN
    PMA / PMN Number
    K101680
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    WELCH ALLYN REQUESTED THE CUSTOMER RETURN THE SPOT LXI, THE HEALTH O METER SCALE AND THE RS-232 INTERCONNECT CABLE FOR EVALUATION. WELCH ALLYN IS REPORTING THIS EVENT IN AN ABUNDANCE OF CAUTION AS IT IS UNCLEAR WHICH DEVICE OR COMPONENT CAUSED THE PROBLEM. THE DEVICE EVALUATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED WITH AN ALLEGATION THAT THEIR SPOT LXI WAS DISPLAYING INACCURATE WEIGHT MEASUREMENTS DURING TESTING OF A NEW HEALTH O METER WEIGHT SCALE. THE SPOT LXI DEVICE WAS CONNECTED TO A HEALTH O METER SCALE WHICH WAS DISPLAYING THE CORRECT WEIGHT, HOWEVER, UPON DATA TRANSFER TO THE SPOT LXI DEVICE, THE WEIGHT MEASUREMENTS WERE OFF BY 30 LBS IN ONCE CASE, AND 140 LBS IN ANOTHER CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    550059 SPOT VITAL SIGNS LXI DXN WELCH ALLYN 450T0-E1

    Patients

    Seq Age Sex Outcome Treatment
    1