BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMERITUS HAVE-A-HEART PROBE COVER

    MDR report key: 7693923 · Received July 17, 2018

    Report

    Report Number
    2080225-2018-00701
    Event Type
    Malfunction
    Date Received
    July 17, 2018
    Date of Event
    July 1, 2018
    Report Date
    July 16, 2018
    Manufacturer
    KENTEC MEDICAL, INC
    Product Code
    KGX
    UDI-DI
    10817522010175
    PMA / PMN Number
    NOT APPLIC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CUSTOMER STATES THAT ON 2 OCCASIONS, THE THERMAL PROBE COVER HAS CAUSED FALSE LOW SKIN TEMPERATURE READINGS AND INCREASED THE ISOLETTE TEMPERATURE, THUS ELEVATING THE PATIENT'S INTERNAL BODY TEMPERATURE. THE ACTUAL TEMPERATURE PROBE IS PRIMARILY RESPONSIBLE FOR TEMPERATURE READINGS, SO IT IS CURRENTLY UNKNOWN IF THE PROBE IS NOT TO BE AT FAULT FOR THESE INCIDENCES. AT THIS TIME, THE CUSTOMER HAS NOT PROVIDED ANY PRODUCT FOR INVESTIGATION/ANALYSIS, AND IT IS UNKNOWN IF THE PRODUCT WILL EVENTUALLY BE RETURNED. AT THIS TIME, INVESTIGATION HAS NOT COMMENCED, AWAITING MORE INFORMATION FROM THE CUSTOMER. THIS TYPE OF COMPLAINT ON THIS DEVICE IS EXTREMELY RARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535212 AMERITUS HAVE-A-HEART PROBE COVER TEMPERATURE PROBE COVER KGX KENTEC MEDICAL, INC 175-S 040418 10817522010175

    Patients

    Seq Age Sex Outcome Treatment
    1 7 WK Other