BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOT DOG

    MDR report key: 9146072 · Received October 2, 2019

    Report

    Report Number
    9146072
    Event Type
    Malfunction
    Date Received
    October 2, 2019
    Date of Event
    August 26, 2019
    Report Date
    September 6, 2019
    Manufacturer
    AUGUSTINE TEMPERATURE MANAGEMENT LLC
    Product Code
    DWJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE HOT DOG PATIENT WARMING PAD WAS PLACED ON GEL ROLLS TO PRE-WARM PRIOR TO PATIENT ARRIVAL TO THE ROOM. MINUTES LATER THE UNIT BEGAN TO ALARM. THE SPECIFIC ALARM INDICATION WAS NOT NOTED. THE YELLOW CORD GOING FROM MACHINE TO PAD WAS UNPLUGGED. IT WAS NOTED THAT THE TOP PORTION OF THE PAD WAS EXTREMELY HOT AND APPEARED TO BE MELTED. THE PAD WAS REMOVED. A NEW PAD AND MACHINE WAS USED FOR THE CASE WITHOUT INCIDENT. THE ORIGINAL CONTROLLER WAS TESTED WITH A DIFFERENT PAD AND IT WORKED FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    940030 HOT DOG SYSTEM, THERMAL REGULATING DWJ AUGUSTINE TEMPERATURE MANAGEMENT LLC B203

    Patients

    Seq Age Sex Outcome Treatment
    1 1460 DA