BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMERITUS TEMPERATURE PROBE

    MDR report key: 10755095 · Received October 29, 2020

    Report

    Report Number
    2080225-2020-00001
    Event Type
    Injury
    Date Received
    October 29, 2020
    Date of Event
    October 8, 2020
    Report Date
    October 27, 2020
    Manufacturer
    KENTEC MEDICAL, INC
    Product Code
    FMT
    UDI-DI
    10817522010045
    PMA / PMN Number
    K960080
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    COMPLAINANT STATED THAT THE TEMPERATURE PROBE AND COVER SEPARATED FROM THE BABY AND CREATED A "TEMPERATURE EVENT". IF THE PROBE AND COVER ARE SEPARATED FROM THE PATIENT, IT CAN CAUSE THE TEMPERATURE SENSOR TO READ THE LOWER AMBIENT TEMPERATURES, WHICH THEN IN TURN, INCREASES THE TEMPERATURE WITHIN THE INCUBATOR, AS IT BELIEVES THE PATIENT IS TOO COLD. COMPLAINANT ALSO STATED THAT HE AND THE CLINICAL STAFF BELIEVE THAT THE ADHESIVE SEPARATED FROM THE PATIENT BECAUSE THEY WERE USING VERY HIGH LEVELS OF HUMIDITY IN THE INCUBATOR, AND DID NOT NECESSARILY BELIEVE IT WAS THE FAULT OF THE DEVICE. COMPLAINANT DECLINED TO PROVIDE ANY DETAILS REGARDING THE PATIENT STATUS OR ANY MEDICAL PROCEDURES THAT MAY HAVE BEEN A RESULT OF THE DEVICE FAILURE, BUT ONLY TO STATE THAT THERE WAS NO DEATH ASSOCIATED WITH THE INCIDENT. THERE HAVE BEEN NO RECENT COMPLAINTS FOR EITHER DEVICES, AND NO OTHER COMPLAINTS FOR THE LOT NUMBERS ASSOCIATED WITH THESE DEVICES. LOT NUMBER OF THE TEMPERATURE PROBE, CATALOG CODE 232, IS P-13879. LOT NUMBER OF THE TEMPERATURE PROBE COVER, CATALOG CODE 120, IS 070920. THE COMPLAINANT LISTED THE TEMPERATURE PROBE AS THE SUSPECT DEVICE, BUT IT APPEARS THAT IT WAS THE PROBE COVER THAT WAS THE DEVICE THAT MALFUNCTIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1221678 AMERITUS TEMPERATURE PROBE TEMPERATURE PROBE FMT KENTEC MEDICAL, INC 232 P-13879 10817522010045

    Patients

    Seq Age Sex Outcome Treatment
    1 3 WK Other