BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3M BAIR HUGGER WARMING UNIT 775

    MDR report key: 11611922 · Received April 4, 2021

    Report

    Report Number
    2110898-2021-00018
    Event Type
    Malfunction
    Date Received
    April 4, 2021
    Date of Event
    March 3, 2021
    Report Date
    April 4, 2021
    Manufacturer
    3M HEALTH CARE
    Product Code
    DWJ
    PMA / PMN Number
    K060865
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN VISUALLY INSPECTED BY TECHNICAL GOVERNANCE MANAGER AT THE HOSPITAL. DEVICE WAS MOUNTED ON A MOBILE POLE-STAND. THERE WAS FAINT EVIDENCE OF A DRIP MARK DOWN THE BACK OF THE DEVICE ABOVE THE MAINS SOCKET AS WELL ON THE BASE OF THE POLE-STAND. USERS REPORTED THAT NO LIQUID INFUSION DEVICES WERE IN USE OR ATTACHED TO THE STAND AT THE TIME OF THE INCIDENT BUT MAY HAVE BEEN MOUNTED IN THE PAST. 3M¿ WILL CONTINUE TO MONITOR.

    Description of Event or Problem · 1

    A HOSPITAL ALLEGED AN ALARM FROM THE WALL CONTROL PANEL ALARMED AND THE CONTROL PANEL DISPLAY SHOWED AN ERROR MESSAGE OF "EARTH FAULT IN BAY 4". ALARM WAS REPORTED TO THE HOSPITAL. APPROXIMATELY TWO HOURS LATER THERE WAS A METALLIC BURNING SMELL. AFTER FIFTEEN MINUTES OF THE METALLIC SMELL A SPARK AND ORANGE FLAME CAME FROM 3M¿ BAIR HUGGER WARMING UNIT 77507 THAT WAS PLUGGED IN A PATIENT'S ROOM. THERE WAS ONE ORANGE FLAME AND THEN THE FLAME SELF-TERMINATED. THE 3M¿ BAIR HUGGER WARMING UNIT WAS TURNED OFF AT THE WALL AND DEVICE WAS UNPLUGGED. THERE WERE NO FURTHER FLAMES AND DEVICE WAS REMOVED FROM USE. NO PATIENT OR STAFF INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509192 3M BAIR HUGGER WARMING UNIT 775 HYPER/HYPOTHERMA SYSTEM, PRODUCT CODE: DWJ DWJ 3M HEALTH CARE 775 125271

    Patients

    Seq Age Sex Outcome Treatment
    1