BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M WARMER SYSTEM

    MDR report key: 24496506 · Received March 3, 2026

    Report

    Report Number
    3032580628-2026-00001
    Event Type
    Malfunction
    Date Received
    March 3, 2026
    Date of Event
    January 24, 2026
    Report Date
    March 3, 2026
    Manufacturer
    MEQU A/S
    Product Code
    LGZ
    UDI-DI
    05700002076816
    PMA / PMN Number
    K232107
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION OF THE RETURNED DEVICE CONFIRMED AN INTERNAL FLUID LEAK IN THE FLUID PATH WHICH LED TO OVERHEATING AS THE DEVICE MALFUNCTION. ROOT CAUSE IS DETERMINED TO BE A MANUFACTURING ERROR WHICH WAS CORRECTED BY 02-JUL-2024. MEQU HAS NOT SEEN ANY DEFECTS ON M WARMERS MANUFACTURED AFTER IMPLEMENTATION OF THE CORRECTION.

    Description of Event or Problem · 0

    THE PRODUCT PROBLEM REPORTED THE M WARMER LEAKED FLUID AND OVERHEATED. THE M WARMER WAS IMMEDIATELY DISCONNECTED. NO HARM OCCURRED TO THE PATIENT. DETAILED DESCRIPTION OF EVENT FROM REPORTER: AFTER CONNECTING THE POWER PACK TO THE M WARMER DEVICE AND APPLYING IT TO THE PATIENT, THE DEVICE INITIALLY OPERATED NORMALLY, HEATING UP WITH A FLASHING GREEN LED. AFTER REACHING OPERATING TEMPERATURE, THE DEVICE DISPLAYED A CONTINUOUSLY ILLUMINATED GREEN LED. AT THAT TIME, THE PATIENT WAS POSITIONED IN A VACUUM MATTRESS IN A GROUND AMBULANCE (RTW), WAS CONSCIOUS AND SEDATED, AND THE FOREARM ON WHICH THE M WARMER DEVICE WAS APPLIED WAS LEFT UNCOVERED TO ALLOW VISUAL MONITORING OF THE DEVICE. TRANSPORT THEN CONTINUED IN THE GROUND AMBULANCE (RTW) TOWARDS THE RESCUE HELICOPTER (RTH). AFTER APPROXIMATELY TWO MINUTES, THE AMBULANCE STOPPED, AND THE M WARMER DEVICE (SN: (B)(6)), TOGETHER WITH THE POWER PACK (SN: (B)(6)), WAS THROWN OUT OF THE AMBULANCE WHILE EMITTING SMOKE (IT WAS REPORTED THAT THE SMOKE OR VAPOR ORIGINATED FROM THE M WARMER DEVICE AND NOT FROM THE POWER PACK). AT THE SAME TIME, THE AMBULANCE CREW REPORTED THAT SHORTLY BEFOREHAND A "DARK LIQUID" HAD LEAKED FROM THE M WARMER DEVICE WHILE THE SYSTEM WAS STILL DISPLAYING A CONTINUOUS GREEN LED. THIS OBSERVATION WAS CONFIRMED BY THE CREW PRESENT. WHEN THE CREW DECIDED TO REMOVE THE SYSTEM FROM THE PATIENT TO PREVENT POTENTIAL HARM, THE LED INDICATOR ON THE M WARMER DEVICE CHANGED TO RED, AND THE CREW PERCEIVED A HISSING SOUND AS WELL AS INTENSE AND UNPLEASANT SMOKE AND ODOR DEVELOPMENT. THE M WARMER DEVICE WAS VERY HOT, EMITTING SMOKE (SMOKE OR VAPOR DEVELOPMENT), AND WAS DISCONNECTED FROM THE POWER PACK BY PULLING THE POWER CABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559277 M WARMER SYSTEM BLOOD AND IV FLUID WARMER, LGZ MEQU A/S MWS201 05700002076816

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown