BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUTEMP PLUS

    MDR report key: 7681117 · Received July 12, 2018

    Report

    Report Number
    7681117
    Event Type
    Malfunction
    Date Received
    July 12, 2018
    Date of Event
    July 2, 2018
    Report Date
    July 5, 2018
    Manufacturer
    KENTEC MEDICAL, INC.
    Product Code
    KGX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE PATIENT'S THERMAL HEART TEMPERATURE PROBE DOES NOT ACCURATELY CORRELATE THE CORRECT TEMPERATURE OF THE VERY LOW BIRTH WEIGH INFANT, WHICH CAUSES FALSE LOW SKIN TEMPERATURE READINGS AND INCREASES THE ISOLETTE TEMPERATURE. THIS OVER HEATS THE INFANT. INFANT FOUND WITH AXILLARY TEMP OF 37.9 CELSIUS. THIS IS OCCURRING ONLY WITH ONE TYPE OF SMALL BABY THERMAL HEART PROBE WITH FOAM BACKING (REF# (B)(4)). NOTED OVER THE LAST COUPLE OF WEEKS THE SIMILAR ELEVATION IN TEMPERATURE ONLY WITH THIS TYPE OF PROBE (NOT USUALLY STOCKED ON OUR UNIT-WE WERE SENT A DIFFERENT PROBE). DESPITE ROUTINE Q3H CHANGE OF THESE NEW PROBE SITE THERMAL COVERS AND ROUTINE SITE CHANGE TAKING CARE NOT TO HAVE INFANT BLANKETS COVER IT OR BABY LAY ON PROBE, INFANT IS NOTED PERIODICALLY TO HAVE THIS ELEVATED TEMPERATURE. ALL PROBES HAVE BEEN REMOVED FROM THE UNIT. MANUFACTURER MADE AWARE BY NURSE MANAGER. PER HOSPITAL, THE MANUFACTURER INFORMED HOSPITAL STAFF THAT THEY HAVE NOT HEARD OF THIS PROBLEM BEFORE WITH THEIR PROBES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524595 ACCUTEMP PLUS HYDROGEL PROBE COVER KGX KENTEC MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 49 DA Other