Arctic Sun Stat 60000000LRecalls & reported problems

Summary

The FDA's MAUDE database contains 104 adverse event reports that list this exact device (DI 00801741161520), received between Oct 31, 2020 and May 20, 2026 — classified as 2 injuries, 102 malfunctions.

The most frequently reported specific device problem is “Defective Component” (21 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jun 27, 2024Open, Classified

   If temperature management system fails to reach correct target water temperature while device is operating in patient control mode, due to sudden patient temperature changes/interruption in water flow/blockage of air flow by an obstruction or dirty filter, then system may not alert, and alarm absence may lead to hypothermia or hyperthermia, so a software update will be released to correct issue.

   Z-2457-2024 · Root cause: Software design · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 104 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 20, 2026Insufficient Cooling

  IT WAS REPORTED THAT THE NURSE REPORTS ALERT 113 (REDUCED WATER TEMPERATURE CONTROL) IN AN ARCTIC SUN DEVICE. PATIENT TEMPERATURE (PT) WAS 38C, TARGETED TEMPERATURE (TT) WAS 37C, WATER TEMPERATURE (WT) WAS 26.9C, FLOW RATE (FR) WAS 2.7LPM. GUIDED TO DIAGNOSTICS: SYSTEM HOURS 2767, PUMP HOURS 438, CHILLER TEMPERATURE (T4) WAS (CHILLER) 26.9C, MIXING PUMP COMMAND (MPC) WAS 100 PERCENT. ADVISED THIS DEVICE WILL NEED TO GO TO BIOMED FOR REPAIR. PER FOLLOW UP INFORMATION RECEIVED VIA PHONE ON 14MAY2026, TRANSFERRED TO THE BIOMED. SPOKE WITH BIOMED WHO STATED THEY WANTED TO COMPLETE A PM ON THIS DEVICE AND REQUIRED A QUOTE FOR ONSITE VS DEPOT ASSESSMENT. NO REPAIRS MADE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25234656 ↗
• MalfunctionMay 17, 2026Nonstandard Device; Calibration Problem

  IT WAS REPORTED THAT THE PER WO EVALUATION, DURING CALIBRATION, AN ERROR 99 OCCURRED- PATIENT TEMPERATURE OUT OF CALIBRATION AND WAS FOUND TO BE A FAULTY ISOLATION CCA IN AN ARCTIC SUN DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25196351 ↗
• MalfunctionJan 30, 2026Restricted Flow rate; Failure to Pump

  IT WAS REPORTED THAT THE CUSTOMER STATED THAT THE ARCTIC SUN DEVICE DISPLAY WAS DAMAGED WHILE AT THEIR SITE. UPDATED WO TO SHOW COMPLAINT. PER SAMPLE EVALUATION RESULTS ON (B)(6) 2025, IT WAS REPORTED THAT THE DEVICE WAS NOT FILLING (CIRCULATION PUMP ISSUE). IT WAS REPORTED THAT THE PRESSURE READING WAS -6.0PSI WITH NO PUMPS RUNNING (PRESSURE TRANSDUCER FAILURE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24223867 ↗
• MalfunctionJan 23, 2026Computer Software Problem

  IT WAS REPORTED THAT THIS LOANER ARCTIC SUN DEVICE BOOTS DIRECTLY TO THE NORMOTHERMIA SCREEN AND BYPASSES THE PATIENT THERAPY SELECTION SCREEN. PER ADDITIONAL INFORMATION UPDATED FROM TTM ON 12JAN2026, THEY HAVE A LOANER DEVICE, SN (B)(6). THEY NEED TO SET THEIR PROTOCOL SETTINGS, BUT THEY WERE NOT SAVING WHEN THEY CYCLE THE POWER. ATTEMPTED TO DIRECT CALLER TO THE ADVANCED SETUP TAB, BUT THE OPTION WAS NOT THERE EVEN AFTER CYCLING THE POWER. BIOMED WAS GOING TO TAKE THE DEVICE TO SHOP AND CALL BACK TO SPEAK WITH TECH SUPPORT. BIOMED CALLING BACK FOR ASSISTANCE WITH LOANER DEVICE THAT WILL NOT ALLOW THE ACCOUNT TO ACCESS THE ADVANCED SET UP. ALREADY TRIED POWERING OFF AND BACK ON MULTIPLE TIMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24172967 ↗
• MalfunctionDec 4, 2025Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE NURSE STATED THEY STARTED COOLING A PATIENT ABOUT AN HOUR AND A HALF AGO. THE TARGETED TEMPERATURE (TT) WAS 36C. THE PATIENT COOLED BELOW THE TARGET AND WAS CURRENTLY 34.9C. S/N (B)(6). CONFIRMED WATER TEMPERATURE WAS 38.5C AND WATER FLOW RATE (WFR) WAS 3.4 L/MIN. NURSE STATED THEY HAD MEDIUM PADS ON THE PATIENT WITH GOOD SKIN COVERAGE. EXPLAINED THE DEVICE WAS MAKING EXTREMELY WARM WATER AND APPEARS TO BE RESPONDING APPROPRIATELY. PATIENT WAS FULLY SEDATED AND WAS NOT SHIVERING, NO SIGNS OF HEAT GENERATION. NURSE STATED WHEN THEY INITIATED THERAPY, THE PATIENT WAS NOT FULLY SEDATED. EXPLAINED THE DEVICE MAY HAVE RECOGNIZED HEAT GENERATION IF THE PATIENT WAS MOVING OR SHIVERING WHICH CAN LEAD TO OVERSHOOT. WATER TEMPERATURE WAS UP TO 40C. SUGGESTED NURSE CONSULT THEIR PROTOCOL FOR COUNTER WARMING SUCH AS WARM BLANKETS, BAIR HUGGER, VENT WARMER ETC. TO HELP INCREASE THE PATIENT'S TEMPERATURE. ALSO DISCUSSED WITH PROLONGED WARM WATER EXPOSURE, THEY MAY INCREASE THEIR SKIN CHECKS FREQUENCY. ENCOURAGED NURSE TO CALL BACK WITH ANY QUESTIONS OR ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23720474 ↗
• MalfunctionSep 24, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT PER REVIEW OF WO NOTES ARCTIC SUN DEVICE HAD A BROKEN PIN ON THE OUTLET TEMPERATURE PORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23133976 ↗
• MalfunctionSep 23, 2025Insufficient Cooling; Insufficient Cooling

  IT WAS REPORTED THAT THE NURSE STATED THAT ARCTIC SUN DEVICE ALERTED 113 REDUCED WATER TEMPERATURE CONTROL WHILE TRYING TO COOL PATIENT. PATIENT TEMPERATURE (PT) WAS 38.4C, TARGETED TEMPERATURE (TT) WAS 36C, WATER TEMPERATURE (WT) WAS 7.2C, WATER FLOW RATE (WFR) WAS 2.7 L/M. SYSTEM DIAGNOSTICS SHOWED THAT THE OUTLET MONITOR TEMPERATURE (T1) WAS 7.1C, OUTLET CONTROL TEMPERATURE (T2) WAS 7.1C, INLET TEMPERATURE (T3) WAS 8.2C, CHILLER TEMPERATURE (T4) WAS 3.8C, WATER FLOW RATE (WFR) WAS 2.7 L/M, INLET PRESSURE (IP) WAS -7.0 PSI, CIRCULATION PUMP COMMAND (CPC) WAS 70 PERCENTAGE, MIXING PUMP COMMAND (MPC) WAS 100 PERCENTAGE, HEATER WAS 0, WATER RESERVOIR LEVEL (WRL) WAS 4, SYSTEM HOURS WERE 1485.4 AND PUMP HOURS WERE 8.0. ADVISED TO SEND TO BIOMED LABELED 113 (REDUCED WATER TEMPERATURE CONTROL) NOT COOLING. PER FOLLOW UP INFORMATION RECEIVED VIA TASK ON 02OCT2025, SPOKE WITH BIOMED WHO CONFIRMED THIS DEVICE WAS ON THE UNIT, BUT UNREPAIRED. THEY WERE WORKING ON SENDING THIS LOANER UNIT BACK AND EXCHANGE FOR ANOTHER WORKING ONE. THEY WERE WAITING ON A SHIPPING PALLET AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23123368 ↗
• MalfunctionJul 17, 2025Insufficient Cooling; Failure to Pump; Insufficient Cooling; Failure to Pump

  IT WAS REPORTED THAT THE IN WO EVALUATION, THE ARCTIC SUN DEVICE WOULD NOT COOL UNLESS THE MIXING PUMP WAS AT 100 PERCENTAGE POWER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22532678 ↗
• MalfunctionJun 5, 2025Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT THEY WERE GETTING LOW FLOW IN AN ARCTIC SUN DEVICE EARLIER. THEY WERE ABLE TO GET IT RESOLVED. THERAPY RAN WELL FOR A FEW HOURS, BUT NOW THEY WERE GETTING LOW FLOW ALERTS AGAIN (ALARM 02). FLOW RATE (FR) WAS 0LPM, INLET PRESSURE (IP) WAS -9PSI, CIRCULATION PUMP COMMAND (CPC) WAS 0 PERCENTAGE. SUGGESTED CHANGING TO ANOTHER DEVICE. NURSE LOCATED S/N DYGXAL029 AND CALLED BACK. PATIENT CONNECTED TO NEW DEVICE, THERAPY STARTED. FLOW RATE (FR) WAS 1.1LPM, INLET PRESSURE (IP) WAS -7PSI, CIRCULATION PUMP COMMAND (CPC) WAS 34 PERCENTAGE PUMP HOURS WERE 2621, SYSTEM HOURS WERE 2730. DURATION ADJUSTED TO MATCH FIRST DEVICE 63:24. SUGGESTED SENDING FIRST DEVICE TO BIOMED. THERAPY CONTINUED ON SECOND DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22151902 ↗
• MalfunctionJun 2, 2025Circuit Failure; Gas/Air Leak; Circuit Failure; Gas/Air Leak

  IT WAS REPORTED THAT THE BIOMED CALLED AND STATED THAT THIS ARCTIC SUN DEVICE LOANER WAS GIVING ALERT 02 DURING USE. PER ADDITIONAL INFORMATION FROM 22MAY2025, IT WAS REPORTED THAT THEY ALREADY HAD THE BIOMED LOOK AT THE ARCTIC SUN DEVICE, BUT THEY WERE NOT ABLE TO HELP. THERAPY STARTED AROUND 1600. THEY WERE GETTING ALERT 02 (LOW FLOW). FLOW 0LPM, INLET PRESSURE (IP) WAS -8.2PSI, CIRCULATION PUMP COMMAND (CPC) WAS 0 PERCENTAGE, CV 0. S/N (B)(6). HAD NURSE DISCONNECT AND RECONNECT THE PADS USING PROPER TECHNIQUE AND CHECK FOR ANY KINKS. THE DAY NURSE, CAME ON THE PHONE AND SAID THE PAD DID NOT HAVE ANY VELCRO DOTS, SO THEY WERE NOT SURE IF IT WAS AN ISSUE WITH THE PAD. THEY GOT BACK ON THE PHONE, ASKED FOR CLARIFICATION (WERE THE STRAPS MISSING, OR JUST THE DOTS ON THE PAD). THEY WERE UNSURE AS THEY HAD NOT INSPECTED THE PAD YET. FLOW RATE (FR) WAS 0LPM, INLET PRESSURE (IP) WAS -6PSI, CIRCULATION PUMP COMMAND (CPC) WAS12 PERCENTAGE, PUMP HOURS 1849.6, SYSTEM HOURS 2262.8. STOPPED THERAPY AND DISCONNECTED PADS. STARTED THERAPY IN MANUAL MODE. FLOW RATE (FR) WAS1.8LPM, INLET PRESSURE (IP) WAS-7.1PSI, CIRCULATION PUMP COMMAND (CPC) WAS 50%. ASKED NURSE TO INSPECT FLUID DELIVERY LINE (

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22125782 ↗
• MalfunctionJun 2, 2025Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE BIOMED CALLED AND STATED THAT THIS ARCTIC SUN DEVICE LOANER WAS GIVING ALERT 02 DURING USE. PER ADDITIONAL INFORMATION UPDATED FROM THE 12112800 ON (B)(6) 2025, IT WAS REPORTED THAT THEY ALREADY HAD THE BIOMED LOOK AT THE ARCTIC SUN DEVICE, BUT THEY WERE NOT ABLE TO HELP. THERAPY STARTED AROUND 1600. THEY WERE GETTING ALERT 02 (LOW FLOW). FLOW 0LPM, INLET PRESSURE (IP) WAS -8.2PSI, CIRCULATION PUMP COMMAND (CPC) WAS 0 PERCENTAGE, CV 0. S/N (B)(6). HAD NURSE DISCONNECT AND RECONNECT THE PADS USING PROPER TECHNIQUE AND CHECK FOR ANY KINKS. THE DAY NURSE, CAME ON THE PHONE AND SAID THE PAD DID NOT HAVE ANY VELCRO DOTS, SO THEY WERE NOT SURE IF IT WAS AN ISSUE WITH THE PAD. THEY GOT BACK ON THE PHONE, ASKED FOR CLARIFICATION (WERE THE STRAPS MISSING, OR JUST THE DOTS ON THE PAD). THEY WERE UNSURE AS THEY HAD NOT INSPECTED THE PAD YET. FLOW RATE (FR) WAS 0LPM, INLET PRESSURE (IP) WAS -6PSI, CIRCULATION PUMP COMMAND (CPC) WAS 12 PERCENTAGE, PUMP HOURS 1849.6, SYSTEM HOURS 2262.8. STOPPED THERAPY AND DISCONNECTED PADS. STARTED THERAPY IN MANUAL MODE. FLOW RATE (FR) WAS 1.8LPM, INLET PRESSURE (IP) WAS-7.1PSI, CIRCULATION PUMP COMMAND (CPC) WAS 50%. ASKED NURSE TO I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22124637 ↗
• MalfunctionMay 27, 2025Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT THEY ALREADY HAD THE BIOMED LOOK AT THE ARCTIC SUN DEVICE, BUT THEY WERE NOT ABLE TO HELP. THERAPY STARTED AROUND 1600. THEY WERE GETTING ALERT 02 (LOW FLOW). FLOW 0LPM, INLET PRESSURE (IP) WAS -8.2PSI, CIRCULATION PUMP COMMAND (CPC) WAS 0%, CV 0. S/N (B)(6). HAD NURSE DISCONNECT AND RECONNECT THE PADS USING PROPER TECHNIQUE AND CHECK FOR ANY KINKS. THE DAY NURSE, CAME ON THE PHONE AND SAID THE PAD DID NOT HAVE ANY VELCRO DOTS, SO THEY WERE NOT SURE IF IT WAS AN ISSUE WITH THE PAD. THEY GOT BACK ON THE PHONE, ASKED FOR CLARIFICATION (WERE THE STRAPS MISSING, OR JUST THE DOTS ON THE PAD). THEY WERE UNSURE AS THEY HAD NOT INSPECTED THE PAD YET. FLOW RATE (FR) WAS 0LPM, INLET PRESSURE (IP) WAS-6PSI, CIRCULATION PUMP COMMAND (CPC) WAS12%, PUMP HOURS 1849.6, SYSTEM HOURS 2262.8. STOPPED THERAPY AND DISCONNECTED PADS. STARTED THERAPY IN MANUAL MODE. FLOW RATE (FR) WAS1.8LPM, INLET PRESSURE (IP) WAS-7.1PSI, CIRCULATION PUMP COMMAND (CPC) WAS 50%. ASKED NURSE TO INSPECT FLUID DELIVERY LINE (FDL). NO VISIBLE SIGNS OF DAMAGE AND PROPERLY SEATED. RECONNECTED THE PAD. FLOW RATE (FR) WAS 1.0LPM, INLET PRESSURE (IP) WAS -7PSI, CIRCULATION PUMP COMMAND (CPC) WAS 34%. DISABLED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22088802 ↗
• MalfunctionMay 23, 2025Defective Component; Computer Operating System Problem; Defective Component; Computer Operating System Problem

  IT WAS REPORTED THAT IN AN ARCTIC SUN DEVICE DURING ALARM 113 FIELD ACTION UPDATE CONTROL PANEL FROZE / REBOOT UNIT TO CONTROL PANEL SCREEN, INVERTED SCREEN - ENTER PASSWORD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22077573 ↗
• MalfunctionMay 15, 2025Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE INFORMATION UPDATED FROM WO AS THE EVAPORATOR OUTLET TUBE EXPANDED, ALLOWING DIVERTER TO SPIN AND FACE THE WRONG DIRECTION, INSTALLED TEST MIXING PUMP TO COOL. NOT COOLING WAS CONFIRMED THROUGH THE PATIENT DATA LOGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22027494 ↗
• MalfunctionMay 14, 2025Insufficient Cooling; Failure to Pump; Insufficient Cooling; Failure to Pump

  IT WAS REPORTED THAT THE INFORMATION UPDATED FROM WO AS THE EVAPORATOR OUTLET TUBE EXPANDED, ALLOWING DIVERTER TO SPIN AND FACE THE WRONG DIRECTION, INSTALLED TEST MIXING PUMP TO COOL. NOT COOLING WAS CONFIRMED THROUGH THE PATIENT DATA LOGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22018294 ↗
• MalfunctionApr 11, 2025Defective Component; Defective Component

  IT WAS REPORTED THAT THE DEVICE STILL HAS SAME ISSUE WITH PREVIOUS WO((B)(4)), EVEN THOUGH IT WAS REPAIRED BY DYMAX (RECEIVED IN KR ON 18 NOV AFTER REPAIR). THIS NEEDS REPEAT REPAIR (WITHIN 90 DAYS) AND WILL BE SENT TO DYMAX AGAIN. (FEB,19, 2025) THIS WILL BE REPAIRED IN SOUTH KOREA, NOT DYMAX. WE'LL START TO REPAIR ONCE THE ARCTICSUN STAT SPARE PART IS ARRIVED. PER SAMPLE EVALUATION RESULTS RECEIVED VIA TASK ON 03APR2025, IT WAS REPORTED THAT THE ALERT 113 FOUND IN EVENT LOG HISTORY, FAULTY CHILLER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21827333 ↗
• MalfunctionApr 1, 2025Inaccurate Flow Rate; Device Sensing Problem; Inaccurate Flow Rate; Device Sensing Problem

  IT WAS REPORTED THAT THEY JUST STARTED NORMOTHERMIA AT 9PM. THE ARCTIC SUN DEVICE APPEARS TO BE HEATING THE PATIENT RATHER THAN COOLING. PATIENT TEMPERATURE (PT) WAS 36.9C, TARGETED TEMPERATURE (TT) WAS 36.5C, WATER TEMPERATURE (WT) WAS 40.2C, WATER FLOW RATE (WFR) WAS 1.1 L/M. ESOPHAGEAL PROBE AND RECTAL PROBE CORRELATE. NO SHIVERING, SEIZURES OR MICRO-SHIVERING. NURSE DENIED ANY ALERTS/ALARMS. SYSTEM DIAGNOSTICS SHOWED THAT THE OUTLET MONITOR TEMPERATURE (T1) WAS 39.6C, OUTLET CONTROL TEMPERATURE (T2) WAS 39.6C, INLET TEMPERATURE (T3) WAS 39.9C, CHILLER TEMPERATURE (T4) WAS 4.6C, WATER FLOW RATE (WFR) WAS 0.9 L/M, INLET PRESSURE (IP) WAS -7 PSI, CIRCULATION PUMP COMMAND (CPC) WAS 31 PERCENTAGE, MIXING PUMP COMMAND (MPC) WAS 0, HEATER WAS 3 PERCENTAGE, WATER RESERVOIR LEVEL (WRL) WAS 5, SYSTEM HOURS WERE 2646.2. ADVISED DEVICE DID HAVE HEATER ENABLED AND APPEARS TO BE WARMING. HAD STOP THERAPY AND RESTART. WATER TEMPERATURE IMMEDIATELY BEGAN ADJUSTING AND DROPPING FROM 38C TO 25.9C. ADVISED TO MONITOR FOR THE NEXT HOUR AND NOTED WATER TEMPERATURE (WT) SHOULD NOT BE INCREASING IF PATIENT TEMPERATURE (PT) WAS ABOVE THE TARGETED TEMPERATURE (TT). ENCOURAGED TO CALL BACK WITH ANY QUES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21738691 ↗
• MalfunctionMar 26, 2025Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE NURSE FROM ANOTHER SHIFT TAGGED AN ARCTIC SUN DEVICE STATED THAT IT WAS BROKEN. ONLY MESSAGE ON THE DEVICE WAS THAT IT WAS REGISTERING A FALSE PATIENT TEMPERATURE (PT) THAT WAS BELOW THE ACTUAL PATIENT TEMPERATURE (PT). CONFIRMED DEVICE WAS CURRENTLY NOT IN USE. ENCOURAGED TO SEND DEVICE TO BIOMED FOR EVALUATION. THEY COULD SIMULATE PATIENT TEMPERATURE (PT) TO TEST AND DETERMINED IF THERE WAS AN ISSUE. NOTED CLINICAL HELPLINE WAS AVAILABLE 24/7 AND THEY COULD CALL WHEN THE ISSUE WAS OCCURRING SO THAT THEY TROUBLESHOOT LIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21697355 ↗
• MalfunctionMar 6, 2025Circuit Failure; Insufficient Cooling; Circuit Failure; Insufficient Cooling

  IT WAS REPORTED THAT PER SAMPLE EVALUATION, REPLACED THE ARCTIC SUN DEVICE TRANSDUCER DUE TO NOT COOLING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21537140 ↗
• MalfunctionMar 6, 2025Insufficient Cooling; Insufficient Cooling

  IT WAS REPORTED THAT PER SAMPLE EVALUATION, REPLACED THE ARCTIC SUN DEVICE TRANSDUCER DUE TO NOT COOLING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21536190 ↗
• MalfunctionFeb 27, 2025Insufficient Heating; Insufficient Heating

  IT WAS REPORTED THAT THE NURSE HAD THE ARCTIC SUN DEVICE ALERTING 113 (REDUCED WATER TEMPERATURE CONTROL). PATIENT WAS CLOSE TO TARGETED TEMPERATURE (TT), SN# (B)(6). TARGETED TEMPERATURE (TT) WAS 33.5F, PATIENT TEMPERATURE (PT) WAS 32.8C, WATER TEMPERATURE (WT) WAS 31.9C, FLOW RATE (FR) WAS 0.7L/M, INLET PRESSURE (IP) WAS -7PSI, CIRCULATION PUMP COMMAND (CPC) WAS 26 PERCENTAGE, MIXING PUMP COMMAND (MPC) WAS 0, HEATER COMMAND (HC) WAS 16 PERCENTAGE. HAD NURSE DISCONNECT THE PADS, ROTATE THE CONNECTOR, AND RECONNECT THE PAD. MADE SURE TUBING WAS STRAIGHT AND NOT KINKED ANYWHERE. AFTER DISCONNECTING AND RECONNECTING FLOW RATE (FR) HAD SETTLED TO 1L/M, WATER TEMPERATURE (WT) WAS INCREASED TO 37C. EXPLAINED TO NURSE WHEN THE FLOW RATE DROPS BELOW 1 L/MIN, THE HEATER CAPACITY DIMINISHES. WHEN THE FLOW RATE DROPS BELOW 0.5 L/MIN, THE HEATER TURNS OFF. THIS WAS AN ADEQUATE FLOW RATE FOR A NEONATE PAD, SUGGESTED THEY MONITOR FLOW RATE IN CASE IT DOES DROP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21480149 ↗
• MalfunctionFeb 26, 2025Circuit Failure; Insufficient Cooling; Circuit Failure; Insufficient Cooling

  IT WAS REPORTED THAT ISSUE FOUND DURING EVALUATION OF ARCTIC SUN DEVICE, REPLACED A TRANSDUCER DUE TO NOT COOLING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21468867 ↗
• MalfunctionFeb 21, 2025Restricted Flow rate; Gas/Air Leak; Restricted Flow rate; Gas/Air Leak

  IT WAS REPORTED THAT THE BIOMED STATED THAT THE USER SENT THE ARCTIC SUN DEVICE DOWN FOR PRESSURE ISSUES. PER ADDITIONAL INFORMATION UPDATED FROM TTM ON 18FEB2025, IT WAS REPORTED THAT THE NURSE TRYING TO START THERAPY ON LOANER. DEVICE PRIMED AND STOPPED. BRAND NEW PADS, NO OTHER DEVICES AVAILABLE. HAD TRY TO START THERAPY AGAIN AND GUIDED TO DIAGNOSTICS SHOWED THAT THE SYSTEM HOURS WERE 128, PUMP HOURS WERE 92, INLET PRESSURE (IP) WAS -13PSI, CIRCULATION PUMP COMMAND (CPC) WAS 0 PERCENTAGE, FLOW RATE (FR) WAS 0LPM. DISCONNECTED AND RECONNECTED PADS USING PROPER TECHNIQUE. NO CHANGE IN VALUES. REMOVED FLUID DELIVERY LINE (FDL) AND NO CHANGES IN VALUES. THEY WOULD SEND THIS DEVICE TO BIOMED FOR INVESTIGATION TOMORROW. BIOMES STATED THAT THEY WERE HAVING LOW FLOW ISSUES WITH A LOANER DEVICE. PER ADDITIONAL INFORMATION UPDATED FROM TTM ON 22FEB2025, BIOMED WAS IN ICU TRYING TO FILL S/N: (B)(6), A LONER, BUT IT WILL NOT FILL. WATER RESERVOIR LEVEL WAS 2. CONFIRMED FILL TUBE WAS PROPERLY POSITIONED, AND PADS WERE NOT ATTACHED. WENT THROUGH FILL RESERVOIR STEPS AGAIN. HAD THEM REMOVE THE FLUID DELIVERY LINE (FDL) AND FEEL FOR SUCTION IN THE SUCTION PORT; NONE WAS FELT. EXPLAINED THEY WO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21434582 ↗
• MalfunctionFeb 14, 2025Restricted Flow rate; Gas/Air Leak; Restricted Flow rate; Gas/Air Leak

  IT WAS REPORTED THAT THE NURSE STATED THEY WERE TRYING TO TROUBLESHOOT LOW FLOW ON ARCTIC SUN DEVICE SN#(B)(6). THEY TRIED TO EMPTY THE PADS AND WAS GETTING AN EMPTY PADS NOT COMPLETE ALERT. HAD THEM DISCONNECTED PADS AND ATTEMPT TO FILL DEVICE. DEVICE WOULD NOT FILL. RECONNECTED PADS AND TRIED TO START THERAPY BUT GOT A RESERVOIR EMPTY ALARM (05). GUIDED TO THERAPY SCREEN AND ATTEMPTED TO DRAIN PADS BUT AGAIN GOT A FAILURE TO COMPLETE. GUIDED TO DIAGNOSTICS, SYSTEM HOURS 100, PUMP HOURS 65, INLET PRESSURE (IP) WAS -11PSI, CIRCULATION PUMP COMMAND (CPC) WAS 0 PERCENTAGE, FLOW RATE (FR) WAS 0LPM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21385491 ↗
• MalfunctionFeb 11, 2025Computer Operating System Problem; Computer Operating System Problem

  IT WAS REPORTED THAT THEY HAD ALARM 64 (NON-RECOVERABLE SYSTEM ERROR CONTROL PROCESSOR) IN AN ARCTIC SUN DEVICE. THE DEVICE WAS UNABLE TO ENABLE PUMP POWER (CONTROL PROCESSOR). TURN THE CONTROL MODULE OFF. WAIT 30 SECONDS AND TURN THE CONTROL MODULE ON. IF ALARM PERSISTS, SEND DEVICE TO BIOMED. HAD NURSE PRESS CONTINUE CURRENT PATIENT, AND EMPTY PADS. THERAPY RESUMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21356773 ↗