BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOTHERM SKIN TEMPERATURE SENSOR

    MDR report key: 447451 · Received March 5, 2003

    Report

    Report Number
    1221261-2003-00010
    Event Type
    Malfunction
    Date Received
    March 5, 2003
    Date of Event
    October 8, 2002
    Report Date
    February 27, 2003
    Manufacturer
    LEVEL 1, INC.
    Product Code
    KPD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    USER ALLEGES THE WIRE SHORTED OUT AND LEFT BLACK SCORCH MARKS ON THE OUTER SHEATH OF TEMPERATURE SENSOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEOTHERM SKIN TEMPERATURE SENSOR SKIN TEMPERATURE SENSOR KPD LEVEL 1, INC. STS-201 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO