BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPOT LXI

    MDR report key: 1504374 · Received October 9, 2009

    Report

    Report Number
    1316463-2009-00002
    Event Type
    Death
    Date Received
    October 9, 2009
    Date of Event
    September 10, 2009
    Report Date
    September 11, 2009
    Manufacturer
    WELCH ALLYN, INC.
    Product Code
    DXN
    PMA / PMN Number
    K040490
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER HAS REQUESTED THE RETURN OF THE DEVICE, AND IS AWAITING ITS RETURN FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    A PEDIATRIC PATIENT WAS BEING SEEN BY A NURSE AT THE PATIENT'S HOME. THE NURSE ATTEMPTED TO USE THE SPOT LXI DEVICE TO CHECK THE VITALS ON THE PATIENT. THE SPOT LXI IS USED TO TAKE INDIVIDUAL MEASUREMENTS OF HEART RATE, TEMPERATURE, BLOOD PRESSURE, AND SPO2, IT IS NOT USED TO CONTINUOUSLY MONITOR A PATIENT'S VITAL SIGNS. THE DEVICE WOULD NOT POWER UP AND COULD NOT BE USED. THE PATIENT WAS THEN SENT TO THE HOSPITAL IN ANOTHER COUNTRY. THE CHILD PASSED AWAY LATER THAT NIGHT. WE HAVE NO INFORMATION TO SUGGEST THAT THE FAILURE OF THIS DEVICE TO POWER ON MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH, BUT WE ARE REPORTING THIS EVENT OUT OF AN ABUNDANCE OF CAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPOT LXI VITAL SIGNS MEASUREMENT DEVICE DXN WELCH ALLYN, INC. 45NT0-E6

    Patients

    Seq Age Sex Outcome Treatment
    1 Death