BEUDAMED
    FDA Adverse Event Summary report: N

    ACCUTEMP PLUS TEMP PROBE COVER

    MDR report key: 12083519 · Received June 29, 2021

    Report

    Report Number
    12083519
    Date Received
    June 29, 2021
    Date of Event
    August 2, 2020
    Report Date
    June 18, 2021
    Manufacturer
    KENTEC MEDICAL, INC.
    Product Code
    FMT
    Report Source
    User Facility report
    Reporter Location
    FL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    BABY IN GIRAFFE ISOLETTE WITH AN ACCUTEMP PLUS TEMP PROBE COVER. BED KEPT REPORTING THE BABY WAS COLD. BABY'S NURSE FOUND BABY'S TEMPERATURE WAS TAKEN AND AXILLARY TEMPERATURE REGISTERED AT 102.8. NURSE CHANGED PROBE COVER AND ALLOWED TEMPERATURE IN BED TO LOWER, AND UNBUNDLED BABY. BABY'S TEMPERATURE WAS CHECKED EVERY 15 MINUTES UNTIL NORMAL TEMPERATURE WAS REACHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    984477 ACCUTEMP PLUS TEMP PROBE COVER WARMER, INFANT RADIANT FMT KENTEC MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA