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	02/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The product problem from new zealand reported the m warmer overheated and leaked fluid after it was disconnected from the patient and left running on a bench.No harm occurred to the patient.Detailed description of event from reporter: the mw device was used to warm approximately 150-200 ml sodium chloride administered via gravity flow through an 18 g cannula in the patient's forearm.Due to low flow, manual pressure was briefly applied to the iv bag to increase flow rate.The patient was positioned laterally during transport, which may have intermittently impeded flow.The user observed normal led indication during heating (red blinking followed by solid green).Pp & mw was removed from the patient and left connected on a bench with no fluid connected but with pp still connected.The warmer was not connected to the patient at the time and believes the nurses left the warmer plugged into the pp on the bench with no fluid going through it.Upon inspection the device remained intact but was hot.A pool of black liquid was observed on the bench, indicating internal leakage.
Additional Manufacturer Narrative
Investigation of the device is ongoing - a follow-up report will be submitted once the conclusions of the root cause have been determined, if possible.

• 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: 24680859
• Report Number: 3032580628-2026-00002
• Device Sequence Number: 9976456
• Product Code: LGZ
• UDI-Device Identifier: 05700002076816
• UDI-Public: 05700002076816
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/24/2026

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: 03/09/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2026
• Initial Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/30/2023
• 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