BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOT DOG PATIENT WARMING SYSTEM MULTIFUNCTION CONTROLLER

    MDR report key: 13051709 · Received December 21, 2021

    Report

    Report Number
    13051709
    Event Type
    Malfunction
    Date Received
    December 21, 2021
    Date of Event
    November 16, 2021
    Report Date
    December 13, 2021
    Manufacturer
    AUGUSTINE TEMPERATURE MANAGEMENT LLC
    Product Code
    DWJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    AFTER THE SURGERY WAS COMPLETED, CLINICAL STAFF STARTED THE NEXT SURGERY. THEN CLINICAL STAFF RECEIVED A CALL FROM THE POST ANESTHESIA CARE UNIT (PACU) ABOUT A "WELT" ON THE PATIENTS LEFT KNEE. DOCTOR WAS GOING TO CHECK ON THE PATIENTS KNEE AFTER HIS SURGERY WAS COMPLETED. DOCTOR DETERMINED IT WAS A BURN ON THE LEFT KNEE. HEALTH CARE PROVIDERS CHECKED THE HOTDOG PATIENT WARMING SYSTEM ON THE CURRENT PATIENT AND IT WAS VERY HOT TO THE TOUCH. THE READING ON THE HOTDOG DEVICE WAS 41 DEGREES WHICH IS NORMAL. THE MACHINE AND THE BLANKET WERE BOTH GOOD ON DATES AND WERE NOT EXPIRED. A BLANKET WAS PLACED ON BOTH PATIENTS CREATING A BARRIER BETWEEN THE HOTDOG BLANKET AND PATIENTS SKIN. THE MACHINE AND BLANKET WERE BOTH REMOVED FROM THE ROOM AND SENT DOWN TO BE LOOKED AT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1950128 HOT DOG PATIENT WARMING SYSTEM MULTIFUNCTION CONTROLLER SYSTEM, THERMAL REGULATING DWJ AUGUSTINE TEMPERATURE MANAGEMENT LLC WC52

    Patients

    Seq Age Sex Outcome Treatment
    1 18980 DA Male Other