°M Warmer System - °M Warmer MWS201Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05700002076816), received between Mar 2, 2026 and May 31, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Temperature Problem” (3 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 31, 2026Temperature Problem

  MFR REPORT #: 3032580628-2026-00002 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 18G 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25344942 ↗
• MalfunctionApr 6, 2026Temperature Problem

  MFR REPORT #: 3032580628-2026-00002 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 18G 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24795896 ↗
• MalfunctionMar 24, 2026Overheating of Device

  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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24680859 ↗
• MalfunctionMar 3, 2026Overheating of Device

  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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24496506 ↗
• MalfunctionMar 2, 2026Temperature Problem

  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 POTENTI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24479976 ↗