Level 1 SW5-HOSE-7Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 50695085000653), received between Apr 26, 2017 and Aug 22, 2022 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K011907); they may or may not involve this specific model.

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.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 22, 2022Overheating of Device; Overheating of Device

  IT WAS REPORTED THE PATIENT WAS BURNED ON HIS LEFT ARM AND ON THE BACK. THE PATIENT WAS ON HER STOMACH. THE EQUIPMENT WAS USED AT 44C DURING INTERVENTION (DURATION NOT AVAILABLE). AS SOON THE EQUIPMENT WAS OVERTEMPERATURE, THE TEAM IMMEDIATELY STOPPED THE EQUIPMENT. NO MEDICAL OR SURGICAL INTERVENTION WAS REPORTED.

  Patient problems: Burn(s)

  MAUDE report 15272058 ↗
• MalfunctionJul 8, 2020Temperature Problem; Temperature Problem

  INFORMATION RECEIVED A SMITHS MEDICAL CONVECTIVE WARMING/LEVEL 1 EQUATOR BLOWERS CAUSED A SECOND DEGREE BURN TO PATIENT UPPER ARM AND UPPER BODY WERE PROVIDED TO REVEAL THE BLISTERS AND REDNESS COVERING THE ENTIRE UPPER ALARM AND SHOULDER. 9% BODY SURFACE BURN. THE TEMPERATURE WAS REPORTED AT 35.5 C BEFORE USING AND 35.9 C AFTER FINDING OUT THE BURN WHEN SHE WOKE UP FOUR HOURS FROM THE BEGINNING OF MEDICAL PROCEDURE OF LEFT COLECTOMY. INFORMATION REVEALED PATIENT WAS RECEIVING WOUND TREATMENT FOR BURNS PER HOSPITAL PROCEDURE DAILY. NO FURTHER INFORMATION AT THIS TIME.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 10247319 ↗
• InjuryMay 23, 2018Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE DURING AN ABDOMINOPERINEAL AMPUTATION, THE PATIENT SUSTAINED BURNS AND BLISTERS (PHLYCTENE) AT THE ARMS AND CHEST, FOLLOWING USE OF THE EQUATOR WARMING BLANKET. THE TRACES OF BURNS HAD BEEN OBSERVED AT THE REMOVAL OF THE DRAPES. WITH THE CURRENT INFORMATION AVAILABLE IT IS NOT CLEAR WHETHER ANY TREATMENT WAS REQUIRED TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE.

  Patient problems: Burn(s); Injury

  MAUDE report 7537127 ↗
• InjuryDec 8, 2017Overheating of Device; Overheating of Device

  INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL LEVEL 1® EQUATOR® CONVECTIVE WARMING DEVICE WAS REPORTED TO HAVE BURNED A PATIENT'S LEGS, LEAVING MARKS. THE BURNS ARE NOTED TO THE PATIENT'S ANKLES AND ARE TREATED DAILY. NO FURTHER ADVERSE EFFECTS WERE REPORTED.

  Patient problems: Burn(s)

  MAUDE report 7101785 ↗
• MalfunctionDec 6, 2017Excessive Heating; Excessive Heating

  IT WAS REPORTED THAT DURING USE OF A THE DEVICE, THE PATIENT SUSTAINED A BURN. THE SEVERITY AND LOCATION OF THE BURN ARE UNKNOWN AT THIS TIME. NO PERMANENT INJURY WAS REPORTED.

  Patient problems: Burn(s)

  MAUDE report 7088800 ↗
• MalfunctionAug 30, 2017Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT A PATIENT SUSTAINED A FIRST DEGREE BURN ON THE LEFT FOREARM WITH THE USE OF A LEVEL 1® EQUATOR® HOSE WITH THERMISTOR. THIS WAS AFTER 4 HOURS AND 30 MINUTES OF USE OF THE DEVICE. THE PATIENT WAS POSITIONED IN A SUPINE POSITION WITH THE ARMS CROSSED. THE OPERATING TEMPERATURE WAS 40 DEGREES CELSIUS. CLINICIANS ENSURED THAT THE INSTALLATION WAS NON-COMPRESSIVE. NO OTHER ADVERSE HEALTH OUTCOMES WERE REPORTED.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 6831141 ↗
• InjuryApr 26, 2017Temperature Problem; Temperature Problem

  IT WAS REPORTED THAT A LEVEL 1® EQUATOR® CONVECTIVE WARMING SYSTEM CONTINUED TO HEAT AFTER THE TEMPERATURE HAD REACHED 45° CELSIUS. THE HOSE USED WITH THE DEVICE WAS DAMAGED. ERYTHEMA WAS FOUND ON THE RIGHT ARM OF THE PATIENT, AFTER AN "INTERVENTION" THAT LASTED AN HOUR AND A HALF. BIAFINE CREAM WAS APPLIED TO THE REDNESS AND THE PATIENT WAS MONITORED FOR 24 HOURS. AFTER 24 HOURS, NO MORE REDNESS WAS OBSERVED. NO PERMANENT INJURY WAS REPORTED. SEE MFR: 3012307300-2017-00914 AND 3012307300-2017-00957.

  Patient problems: Burn, Thermal; Erythema

  MAUDE report 6524760 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K011907. One submission often covers many models, so check the product and lot details in each record.

• Z-0497-05 · Dec 15, 2004 · Terminated
  Equator Forced Air Convective Warming System, Reference Number EQ 5000