Arctic Sun® Temperature Management System, Power Cord 73300Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741080258), received between Jul 5, 2023 and Jun 3, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Power Problem” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 3, 2025Defective Component; Defective Component

  IT WAS REPORTED THAT THE ARCTIC SUN DEVICE WAS NOT COOLING. A CHECK OF THE DIAGNOSTICS SHOWED THAT THE CHILLER TEMPERATURE (T4) WAS AT 23C. THEY STATED THAT MORE THAN 600 ML DRAINED FROM THE CHILLER TANK. THEY DISCUSSED THIS WAS INDICATIVE OF A FAILED CHILLER. PER FOLLOW UP INFORMATION REC EIVED VIA TASK ON 02APR2025, NO PATIENT INVOLVED AT THE TIME OF THE MALFUNCTION. PER SAMPLE EVALUATION RESULTS RECEIVED VIA TASK ON 08MAY2025, THE DEVICE FAILED AN ELECTRICAL SAFETY TEST STEP 2(3) MAIN CABLE CHECK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22132773 ↗
• MalfunctionMar 27, 2025Circuit Failure; Circuit Failure

  IT WAS REPORTED THAT THE SCREEN STAYED BLACK IN AN ARCTIC SUN DEVICE. PER REVIEW OF WO ON (B)(6) 2025, THERE WAS NO PATIENT INVOLVEMENT. PER FOLLOW UP INFORMATION RECEIVED VIA TASK ON 12MAR2025, THE DEVICE WOULD BE SENT TO TASK MANAGEMENT FOR REPAIR. DEVICE HAS NOT BEEN SERVICED YET. PER SAMPLE EVALUATION RESULTS RECEIVED VIA TASK ON 25MAR2025, IT WAS REPORTED THAT THERE WAS AN ELECTRICAL SAFETY TEST FAILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21709691 ↗
• MalfunctionNov 30, 2023Circuit Failure; Power Problem; Circuit Failure; Power Problem

  IT WAS REPORTED THAT THE WATER TEMPERATURE DROPPED OUT AND PATIENT TEMPERATURE PLUMMETED ON THE BACK OF THIS IN AN ARCTIC SUN DEVICE. THIS HAPPENED TWICE DURING THE REWARM PHASE OF THERAPY. PER SAMPLE EVALUATION RESULTS ON 13NOV2023, IT WAS REPORTED THAT THE ARCTIC SUN DEVICE FAILED THE PROTECTIVE EARTH DURING EST DUE TO HIGH RESISTANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18237367 ↗
• MalfunctionJul 18, 2023Defective Component; Power Problem; Defective Component; Power Problem

  IT WAS REPORTED THAT IN FIRST CALL, NURSE STATED THAT THEY HAD A PATIENT ON ARCTIC SUN DEVICE AND WHEN THEY RETURNED TO THE ROOM THE DEVICE WAS POWERED OFF. IT HAD NOT BEEN UNPLUGGED OR TOUCHED. THEY HAVE SWITCHED OUTLETS, BUT IT WOULD NOT TURN ON. VERIFIED DEVICE WAS NOT PLUGGED INTO BED. NOTED IF THE DEVICE WOULD NOT POWER ON, THEN THEY WOULD NEED TO SWAP OUT FOR NEW DEVICE AND SEND THIS ONE TO BIOMED FOR EVALUATION. IN SECOND CALL, BIOMED BEDSIDE IN ICU WITH NURSE. DEVICE HAD BEEN ALERTING PATIENT LINE OPEN AND LOW FLOW. NURSE STATED THAT THE PADS HAD BEEN ON FOR LESS THAN ONE SHIFT, BUT THEY HAD ISSUES SINCE THE START OF THERAPY. BIOMED CHECKED CONNECTIONS AND CHANGED OUT THE FLUID DELIVERY LINE (FDL) BECAUSE IT APPEARED WORN. WALKED THROUGH STOP THERAPY, DRAIN AND DISCONNECT. RECONNECTED HOLDING NOWHERE NEAR CLEAR CONNECTORS. VERIFIED AUDIBLE CLICKS WITH EACH CONNECTION. ALL LINES STRAIGHT WITH NO BENDS OR KINKS AND VERIFIED THAT FLUID DELIVERY LINE (FDL) WAS SECURE IN THE LOCK POSITION. RESTARTED THERAPY AND DEVICE WOULD PRIME TO WATER FLOW RATE (WFR) WAS 0 L/M AND ALERTING LOW AIR LEAK AND PATIENT LINE OPEN. SYSTEM DIAGNOSTICS WERE OUTLET MONITOR TEMPERATURE (T1) WAS 7.3C, O

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17341908 ↗
• MalfunctionJul 5, 2023Power Problem; Power Problem

  IT WAS REPORTED THAT THE RESPIRATORY CAME IN WHILE REWARMING PATIENT AND UNPLUGGED ARCTIC SUN DEVICE FROM THE WALL. AT SOME POINT SPARK FROM WALL OCCURRED IN THE ROOM. THEY WERE MOVING PATIENT AND DEVICE TO A NEW ROOM. WANTED TO KNOW HOW TO CONTINUE THERAPY. TARGETED TEMPERATURE (TT) WAS 37C AND PATIENT TEMPERATURE (PT) WAS 36.8C. ADVISED TO PLUG IN DEVICE IN NEW ROOM. AT BOOT UP SELECT CONTINUE CURRENT PATIENT AND START UNDER REWARM WHERE THEY LEFT OFF. AFTER SPARK OCCURRED IN OTHER ROOM THEY MOVED PATIENT TO NEW ROOM AND HAVE PLUGGED IN THE DEVICE TO RESUME THERAPY. DEVICE WOULD NOT POWER ON. ADVISED THEY WOULD NEED TO SEND THIS DEVICE TO BIOMED FOR EVALUATION. ELECTRICAL ISSUE IN OTHER ROOM POSSIBLY DAMAGED THE DEVICE. CONFIRMED THEY DID NOT HAVE ANOTHER DEVICE AVAILABLE FOR USE. WILL NEED TO CONSULT PROTOCOL ON ALTERNATE METHOD FOR THERAPY. BIOMED CALL. A NURSE PLUGGED IN DEVICE AND IT SPARKED THE NIGHT BEFORE. BIOMED HAD WORKED ON THE DEVICE AND REPLACED THE POWER CORD. THEY WOULD LIKE TO DO A FUNCTIONAL CHECK AND MAKE SURE EVERYTHING WAS WORKING APPROPRIATELY. WARM TRANSFERRED FOR PROPER HANDLING. PER FOLLOW UP INFORMATION RECEIVED VIA EMAIL ON 20JUL2023, (SEE ATTACHMENT). IT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17263198 ↗