Level 1 EQ-5000 115VRecalls & reported problems
Icu Medical, Inc. · Class 2
All models of Level 1 (52)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15019517116175), received between Dec 28, 2023 and Dec 28, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Overheating of Device” (1 report).
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Overheating of Device1
Patient problems
- Full thickness (Third Degree) Burn1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 28, 2023Overheating of Device; Overheating of Device
IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC PROCEDURE AND SUSTAINED A 3 PERCENT BSA BURN OF HER RIGHT LEG AFTER THE LEVEL 1¿ CONVECTIVE WARMER DEVICE WAS DETACHED FROM A WARMING BLANKET. IT IS FURTHER ALLEGED THAT LATER INSPECTION FOUND THAT THE WARMING DEVICE WAS BLOWING SIGNIFICANTLY HOTTER AIR THAN SET TEMPERATURES. THE PATIENT IS REPORTED TO HAVE UNDERGONE EXCISIONAL DEBRIDEMENT AND SPLIT THICKNESS AUTOGRAFTING FOR WOUND CLOSURE TO THE BURNS ON THE RIGHT LEG.
Patient problems: Full thickness (Third Degree) Burn
MAUDE report 18411023 ↗
Other System, thermal regulating devices
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- Arctic Sun® 5000 50000000LMedivance, Inc. · System, thermal regulating1 recall388 reports
- Arctic Sun® Temperature Management System, ArcticGel™ Pads 31802Medivance, Inc. · System, thermal regulating1 recall385 reports
- Altrix 8001Stryker Corporation · System, thermal regulating1 recall160 reports
- Arctic Sun Stat 60000000LMedivance, Inc. · System, thermal regulating1 recall104 reports
- HotDog Temperature Management System WC77Augustine Temperature Management LLC · System, Thermal Regulating2 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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