MAUDE Adverse Event Report: MEQU A/S M WARMER SYSTEM; BLOOD AND IV FLUID WARMER,

Model Number	MWS201
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
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.

• Brand Name: M WARMER SYSTEM
• Common Device Name: BLOOD AND IV FLUID WARMER,
• Manufacturer (Section D): MEQU A/S; fruebjergvej 3; copenhagen, 2100 ; DA 2100
• Manufacturer (Section G): PAUL E. DANCHELL A/S; lyngvej 8; jyderup, 4450 ; DA 4450
• Manufacturer Contact: laila lundtoft ; fruebjergvej 3; copenhagen, 2100 ; DA 2100
• MDR Report Key: 24496506
• Report Number: 3032580628-2026-00001
• Device Sequence Number: 4979803
• Product Code: LGZ
• UDI-Device Identifier: 05700002076816
• UDI-Public: 05700002076816
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K232107
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/03/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MWS201
• Device Catalogue Number: MWS201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/04/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown