In-Line Gas Warmer 6-820-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00817183020233), received between Aug 29, 2018 and Dec 8, 2023 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Thermal Decomposition of Device” (5 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 8, 2023Overheating of Device; Overheating of Device

  ON 09NOV2023 NORTHGATE TECHNOLOGIES INC. WAS MADE AWARE OF THE ALLEGED EVENT THAT OCCURRED IN JAPAN ON (B)(6) 2023 WHERE IT WAS ALLEDGED "BEFORE PATIENT USE AND DURING SETTING UP, WHEN THE USER CONNECTED THE WARMER WITH THE NEBULAE I UNIT AND HE PUSHED START BUTTON, THE WARMER WAS SMOKING. THE TAG WAS CUT OUT AND THE SN WAS UNKNOWN, BUT THE WARMER HAS BEEN USED FOR APPROX.100 TIMES ACCORDING TO THE STAFF OF THE HOSPITAL. ACTION: THEY USED THE OTHER UNIT."NO PATIENT INJURY WAS REPORTED, AS THIS OCCURRED DURING SETUP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18297688 ↗
• InjuryJan 24, 2022Overheating of Device; Overheating of Device

  ON 1/5/2022 NORTHGATE TECHNOLOGIES, INC WAS MADE AWARE OF THE ALLEGED EVENT ON AN IN-LINE WARMER, " LAPAROSCOPIC HYSTERECTOMY WAS PERFORMED USING THE NEBULAE AND THE IN LINE WARMER. THERE WAS AN ISSUE WITH THE IN LINE WARMER THAT WAS INDICATED ON THE NEBULAE. UNFORTUNATELY, THE DEVICE WAS NOT DISCONNECTED AND THE CABLE BECAME VERY HOT TO TOUCH (WHICH WAS ONLY DISCOVERED AT THE END OF THE CASE). THE PATIENT WAS BADLY BURNED FORM THE IN LINE WARMER CABLE." UPON FURTHER FOLLOW UP THE BURN WAS CATEGORIZED AS "2 DEGREE BURN TO FLANK. ABOUT 4X4 CM. FLAMOZINE CREAM TO TREAT BURNS AND A DRESSING WAS APPLIED. THE PATIENT WAS DISCHARGED HOME THE NEXT DAY. "

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 13338935 ↗
• MalfunctionNov 6, 2020Overheating of Device; Overheating of Device

  ON (B)(6) 2020, NORTHGATE TECHNOLOGIES WAS MADE AWARE OF AN ISSUE WITH AN IN-LINE WARMER FROM DISTRIBUTOR AMCO IN (B)(6) WHERE IT WAS ALLEGED, "SHORTLY AFTER STARTING TO USE NEBULAE I AND THE WARMER, THE USER NOTICED SMOKE WAS COMING OF THE WARMER AND THE WARMER HEATED UP TO TOO HIGH TEMPERATURE WITHOUT AN ALARM." THE PATIENT SUFFERED A 2MM BURN INJURY.

  Patient problems: Burn(s)

  MAUDE report 10802174 ↗
• MalfunctionAug 11, 2020Thermal Decomposition of Device; Overheating of Device; Thermal Decomposition of Device; Overheating of Device

  ON 7/13/2020, NORTHGATE TECHNOLOGIES WAS MADE AWARE OF AN ISSUE WITH AN IN-LINE WARMER FROM DISTRIBUTOR AMCO IN (B)(4) WHERE IT WAS ALLEGED, "SHORTLY AFTER STARTING TO USE NEBULAE I AND THE WARMER, THE USER NOTICED THE WARMER HEATED UP TO TOO HIGH TEMPERATURE WITHOUT AN ALARM AND ANY SYMBOL. THEY DIDN'T NOTICE A HIGH TEMPERATURE OR THE WARMER DIDN'T GET TOO HOT BEFORE STARTING INSUFFLATION. OUR TECH DID A REPEATABLE TEST, BUT THE BEHAVIOR WAS NOT FOUND." THERE WAS NO ADVERSE EFFECT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10391576 ↗
• MalfunctionFeb 13, 2020Thermal Decomposition of Device; Thermal Decomposition of Device

  ON 1/17/2020, NORTHGATE TECHNOLOGIES WAS MADE AWARE OF AN ISSUE WITH AN IN-LINE WARMER FROM DISTRIBUTOR (B)(4) IN (B)(4) WHERE IT WAS ALLEGED, "OUR CUSTOMER COULDN'T USE THE PRODUCT AND ASKED US TO CHECK IT. DURING OUR INSPECTION, EVEN THOUGH THE WARMER CONNECTED TO NEBULAE I, THE UNIT DIDN'T DISPLAY ANY THERMOMETER SYMBOL. AND AFTER THAT, THE WARMER HEATED AND SMOKED WITH NO ALARM....NO ADVERSE EVENT AND NO DELAYED PROCEDURE..."

  Patient problems: No Patient Involvement

  MAUDE report 9708950 ↗
• MalfunctionMar 21, 2019Thermal Decomposition of Device; Thermal Decomposition of Device

  ON 2/22/2019, NORTHGATE TECHNOLOGIES WAS MADE AWARE OF AN ISSUE WITH AN IN-LINE WARMER FROM DISTRIBUTOR (B)(4) WHERE IT WAS ALLEGED, "FIVE MINUTES PASSED AFTER THE GAS WARMER CONNECTED TO THE UNIT, SMOKE OCCURRED FROM THE CONNECTED PART OF THE WARMER AND TUBING. ACCORDING TO THE USER, HE DID NOT SEE THE SIGN FOR OVER-TEMPERATURE ALERT AND DID NOT HEAR THE ERROR SOUND EMITTED. THE ISSUE IS NOT DUPLICATIVE AT OUR OFFICE BUT THE GAS COULD NOT FLOW THROUGH THE GAS WARMER. (NOT DUPLICATIVE AT OUR OFFICE) (VISIBLE BURN MARKS ON THE SURFACE)."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8439732 ↗
• InjuryMar 13, 2019Thermal Decomposition of Device; Thermal Decomposition of Device

  ON (B)(6) 2019, NORTHGATE TECHNOLOGIES WAS MADE AWARE OF AN ISSUE WITH AN IN-LINE WARMER FROM DISTRIBUTOR (B)(4) WHERE IT WAS ALLEGED, "THE ALARM OF OVERHEATING OF THE GAS WARMER EMITTED AND THE PATIENT GOT 3 DEGREE BURN ON THE SURFACE OF THE SKIN NEAR A NAVEL."

  Patient problems: Burn, Thermal

  MAUDE report 8416203 ↗
• MalfunctionAug 29, 2018Thermal Decomposition of Device; Thermal Decomposition of Device

  NORTHGATE TECHNOLOGIES INCORPORATED WAS NOTIFIED VIA E-MAIL ON (B)(6) 2017 BY CUSTOMER (B)(4) (DISTRIBUTOR IN (B)(4)) IN IT WAS ALLEGED: "THE CUSTOMER FOUND THAT SMOKE OCCURRED FROM THE PART OF IN-LINE WARMER SOON AFTER THEY CONNECT THE WARMER TO THE UNIT. AS A RESULT, THE PART OF THE WARMER WAS BURNT. 2) ALSO, THEY FOUND THE CONNECTING PARTS OF THE IN-LINE WARMER WAS DAMAGED, WHEN THEY REMOVED THE PRODUCT FROM THE SOCKET."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7831444 ↗