CritiCool 200-00236Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07290107581110), received between Apr 30, 2020 and Jun 16, 2022 — classified as 1 death, 10 malfunctions.

The most frequently reported specific device problem is “Insufficient Cooling” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Jul 20, 2021Open, Classified

   Premature pump failure may lead to the device displaying a HALT 4 error, from which the device cannot recover even after device reboot. The issue may potentially lead to delayed treatment and a failure to deliver the prescribed thermoregulation therapy. To date, the firm has received one report of death potentially related to this issue.

   Z-0153-2023 · Root cause: Component design/selection · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• DeathJun 16, 2022Unexpected Shutdown; Unexpected Shutdown

  CRITICOOL MACHINE DISPLAYED "HALT RESTART" ON SCREEN AND MACHINE STOPPED COOLING PT. MACHINE WAS RESTARTED BUT DIDN'T WORK AT ALL. COOLING FUNCTION NEVER RESUMED. PT UNABLE TO BE REWARMED IN A CONTROLLEC ENVIRONMENT.

  Patient problems: Respiratory Distress Syndrome of Newborns

  MAUDE report 14713025 ↗
• MalfunctionJan 20, 2022No Device Output; No Device Output

  THE DISTRIBUTOR REPORTED THE FOLLOWING: "WHILE THE CRITICOOL IS RUNNING, CONNECTED TO THE CHILD FOR MORE THAN 20 HOURS, THE CRITICOOL STARTS RINGING WHEN THE PATIENT IS NOT BEING CARED FOR (WITHOUT THE PATIENT MOVING OR ANYTHING ELSE) AND INDICATES THE FOLLOWING MESSAGE: "RESTART THE DEVICE", WHICH WE DO BY TURNING THE DEVICE OFF AND ON AGAIN, SINCE NO MANOEUVRE IS POSSIBLE FROM THE DEVICE'S CONTROL PANEL. ONCE THE DEVICE IS TURNED ON AGAIN, THE LOADING SCREEN APPEARS, BUT AFTER TWO SMALL LOADING SQUARES IT DOES NOT MOVE FORWARD, AND THE "RESTART THE DEVICE" ERROR SCREEN APPEARS AGAIN. WE PERFORM THE MANEUVER THREE TIMES WITHOUT SUCCESS. IT IS THEN IMPOSSIBLE FOR US TO HAVE ACCESS TO THE TEMPERATURE CONTROL PANEL OF THE PATIENT, OR EVEN TO KNOW IF THE COOLING IS STILL IN PROGRESS. GIVEN THE SERIOUSNESS OF THE SITUATION, A SECOND DEVICE BORROWED FROM THE PEDIATRIC RESUSCITATION UNIT IS USED TO CONTINUE THERAPEUTIC HYPOTHERMIA ON THE PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13311846 ↗
• MalfunctionSep 24, 2021No Apparent Adverse Event; No Apparent Adverse Event

  THE FOLLOWING REPORT WAS RECEIVED INVOLVING A CRITICOOL: "SURFACE CORD "SEEMS TOO HEAVY" AT CONNECTION TO CRITICOOL MACHINE, CAUSES ALARMS AND REQUIRES MANUAL OVERRIDE · DURING FIRST USE, MACHINE REVERTED TO ADULT MODE, REQUIRING MANUAL OVERRIDE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12530694 ↗
• MalfunctionSep 24, 2021Insufficient Cooling; Insufficient Cooling

  THE FOLLOWING REPORT WAS RECEIVED INVOLVING A CRITICOOL: "REWARMED INFANT: PT WAS COOLED ON TRANSPORT, REACHING THERAPEUTIC TEMPERATURES ON 8/20 @ 2150. PT PLACED ON CRITICOOL MACHINE UPON ADMISSION 8/21 @ 0000. AT 2000, NOTED TO BE WARM, AXILLARY 36.7 CELSIUS WHILE CORE TEMP READ 32.7 CELSIUS. CORE TEMP CORD REPLACED THEN MACHINE REPLACED AND PATIENT REACH THERAPEUTIC TEMPERATURE AGAIN 8/21 @ 2115."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12530311 ↗
• MalfunctionJul 15, 2021Insufficient Cooling; Insufficient Cooling

  THE USER FACILITY REPORTED THAT THE CRITICOOL WAS WARMING INSTEAD OF COOLING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12178522 ↗
• MalfunctionJun 2, 2021No Apparent Adverse Event; No Apparent Adverse Event

  THE USER FACILITY REPORTED THAT THE CRITICOOL REWARMED THE PATIENT TOO QUICKLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11925461 ↗
• MalfunctionApr 28, 2021Insufficient Cooling; Infusion or Flow Problem; Insufficient Cooling; Infusion or Flow Problem

  BELMONT MEDICAL TECHNOLOGIES RECEIVED THE FOLLOWING REPORT INVOLVING A CRITICOOL FROM THE RN NURSE SPECIALIST AT THE HOSPITAL: "THE PATIENT WAS NOTED TO BE WARMER THEN THE SET TEMPERATURE - THE CRITICOOL WAS NOT ALARMING. THE CRITICOOL UNIT WAS CHANGED OUT TO A BLANKETROL UNIT AT THAT TIME. OUR SECOND CRITICOOL UNIT WAS IN USE AT THE TIME. OUR STAFF TRIED TO EMPTY THE UNIT AFTER THE CHANGE OF EQUIPMENT AND THE UNIT IS NOW ALARMING - "HALT 4" ON THE HOME SCREEN. SO WE ARE UNABLE TO DRAIN THE EXISTING WATER FROM THE UNIT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11742107 ↗
• MalfunctionMar 10, 2021Infusion or Flow Problem; Infusion or Flow Problem

  BELMONT'S CLINICAL SPECIALIST RECEIVED A REPORT FROM THE USER FACILITY AND REPORTED THE FOLLOWING: (B)(6) RN, CALLED THE HOTLINE AT 330AM REGARDING A CRITICOOL THAT WAS SHOWING A HALT ALARM. AFTER 60 HRS OF USING THE DEVICE ON THE PATIENT THE DEVICE DISPLAYED A "HALT 1 PLEASE RESTART" ALARM. THE USER TURNED THE DEVICE OFF AND WAITED A FEW SECONDS BEFORE TURNING IT BACK ON. THE DEVICE THEN BEGAN DISPLAYING A "HALT 4" ALARM."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11457952 ↗
• MalfunctionFeb 11, 2021No Apparent Adverse Event; No Apparent Adverse Event

  THE USER FACILITY REPORTED THAT THE CRITICOOL WAS NOT DISPLAYING A CORE TEMPERATURE DURING TRANSPORT OF A PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11318193 ↗
• MalfunctionFeb 5, 2021No Apparent Adverse Event; No Apparent Adverse Event

  BELMONT'S SALES REPRESENTATIVE RECEIVED A REPORT FROM THE USER FACILITY THAT AFTER USING THE CRITICOOL ON A HYPERTHERMIC PATIENT, THE PATIENT EXHIBITED A BURN MARK ON THE KNEE AND MARKINGS TO HIS/HER BACK. IT WAS REPORTED THAT THE MACHINE WAS SET TO 38 DEGREES C.

  Patient problems: Erythema

  MAUDE report 11290009 ↗
• MalfunctionApr 30, 2020Temperature Problem; Temperature Problem

  THE USER FACILITY REPORTED THAT THE CRITICOOL WAS NOT COOLING TO THE SET TEMPERATURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10015039 ↗