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Level 1 SWU-2010Recalls & reported problems

Icu Medical, Inc. · Class 2

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 10610586043390), received between Jun 29, 2018 and Jun 29, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Temperature Problem” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Temperature Problem1

Patient problems

  • Superficial (First Degree) Burn1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryJun 29, 2018Temperature Problem; Temperature Problem

    INFORMATION WAS RECEIVED INDICATING THAT DURING USE OF A SMITHS MEDICAL LEVEL 1 SNUGGLE WARM BLANKETS CONVECTIVE WARMING SYSTEM THE PATIENT WAS NOTED TO BE BURNED. IT WAS REPORTED THAT THE BURNS WERE LOCATED ON THE BODY NEAR WHERE THE HOSE'S CONNECTION PORT WAS AND THAT "MEDICAL TREATMENT" WAS PERFORMED. THERE WERE NO FURTHER REPORTED ADVERSE EFFECTS.

    Patient problems: Superficial (First Degree) Burn

    MAUDE report 7652836 ↗

Other System, thermal regulating devices

All System, thermal regulating devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.