Level 1 SWU-2009Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10610586043383), received between Feb 20, 2018 and Nov 21, 2018 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Temperature Problem” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 21, 2018Malposition of Device; Malposition of Device

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL SNUGGLE WARM PEDIATRIC CONVECTIVE WARMING BLANKET WAS USED FOR APPROXIMATELY FIVE AND A HALF HOURS ON AN INFANT DURING CARDIAC SURGERY. INITIALLY, THE PRODUCT WAS DISINFECTED WITH CHLORHEXIDINE AND WAS SET TO 40 DEGREES CELSIUS FOR THE FIRST ONE AND A HALF HOURS OF USE. THE PATIENT WAS POSITIONED ABOVE THE BLANKET DURING THE OPERATION, AND THEIR BUTTOCKS WERE LAID ON THE PORTION OF THE BLANKET WHERE A SHOULDER SHOULD BE APPLIED TO. THE NEXT TWO HOURS, THE PRODUCT WAS USED WITH THE BLOWING SETTING (ROOM AIR REPORTED TO BE ABOUT 22 DEGREES). EXTRACORPOREAL CIRCULATION WAS CONDUCTED USING AN ARTIFICIAL CARDIOPULMONARY APPARATUS AND AIR WAS KEPT VENTILATED. THE PATIENT WAS MONITORED BY RECTAL, SKIN, AND PHARYNGEAL TEMPERATURE MEASUREMENTS. IT WAS NOTED AT AN UNSPECIFIED TIME THAT THE RECTAL TEMPERATURE FELT "HIGHER THAN USUAL". FOR THE REMAINING TWO HOURS OF USE, WHILE THE PATIENT RECOVERED FROM ANESTHESIA, THE BLANKET WAS WARMED UP TO 36 DEGREES CELSIUS. IT WAS THEN DISCOVERED AFTER THE OPERATION THAT THE PATIENT SUSTAINED FIVE TO SIX RED RASHES (SIZED EIGHT TO TEN MM) AT THE SIDES OF THE INFANT'S BUTTOCKS. THE FOLLOWING DAY, IT WAS REPO

  Patient problems: Burn, Thermal; No Code Available; Rash

  MAUDE report 8097655 ↗
• MalfunctionFeb 20, 2018Temperature Problem; Temperature Problem

  INFORMATION WAS RECEIVED INDICATING THAT A PATIENT USING A SMITHS MEDICAL LEVEL 1® SNUGGLE WARM® BLANKET SUSTAINED BURN MARKS. REPORTED RED AREAS AND SPOTS OF DARKER RED WERE NOTED. THERE WERE NO FURTHER ADVERSE EFFECTS REPORTED.

  Patient problems: Burn(s)

  MAUDE report 7284237 ↗
• InjuryFeb 20, 2018Temperature Problem; Temperature Problem

  INFORMATION WAS RECEIVED INDICATING THAT A PATIENT USING A SMITHS MEDICAL LEVEL 1® SNUGGLE WARM® BLANKET SUSTAINED BURN MARKS. REPORTED RED AREAS AND SPOTS OF DARKER RED WERE NOTED. THERE WERE NO FURTHER ADVERSE EFFECTS REPORTED.

  Patient problems: Burn(s)

  MAUDE report 7284202 ↗