Arctic Sun® Temperature Management System, ArcticGel™ Pads 31802Recalls & reported problems

Summary

The FDA's MAUDE database contains 385 adverse event reports that list this exact device (DI 00801741132131), received between Oct 26, 2020 and Sep 26, 2026 — classified as 5 injuries, 380 malfunctions.

The most frequently reported specific device problem is “Inaccurate Flow Rate” (226 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 18, 2026.

Recalls naming this device

1. Feb 16, 2024Class IIOpen, Classified

   Neonatal pads are experiencing reduced water flow, which may reduce or prevent water heating or cooling performance of the pads that are part of a temperature management system.

   Z-1381-2024 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 385 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 26, 2026Inaccurate Flow Rate

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50908457 ↗
• MalfunctionJul 31, 2026Restricted Flow rate

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50100485 ↗
• MalfunctionJul 27, 2026Inaccurate Flow Rate

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50022125 ↗
• MalfunctionJul 7, 2026Device Sensing Problem

  IT WAS REPORTED BY CRITICAL CARE NURSES IN AN ONLINE SURVEY THAT A NURSE STATED THE ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM DID NOT SUCCESSFULLY CONTROL PATIENT TEMPERATURE BY ACHIEVING AND MAINTAINING PATIENT TO TARGET TEMPERATURE BECAUSE "FAULTY PAD, REPLACED AND TEMPERATURE CONTROL WAS ACHIEVED" IN RELATION TO "ARCTIC SUN 5000" AND PADS "NEONATAL". ADDITIONALLY, IN THE ONLINE SURVEY, IN CHART 6 A NURSE STATED THAT NO, THE ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM DID NOT SUCCESSFULLY MONITOR THE PATIENT'S TEMPERATURE THROUGHOUT THERAPY BECAUSE "FAULTY PAD" IN RELATION TO "ARCTIC SUN 5000" AND PADS "NEONATAL".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25739075 ↗
• MalfunctionJul 2, 2026Patient Device Interaction Problem

  IT WAS REPORTED BY CRITICAL CARE NURSES IN AN ONLINE SURVEY THAT A NURSE STATED THAT AN ADVERSE EVENT WAS EXPERIENCED AS A RESULT OF THE CHAIR SESSION, THIS BEING, NONE WHILE USING ARCTIC SUN 5000 WITH PADS LARGE (L). ADDITIONALLY, A NURSE STATED THAT THE PATIENT EXPERIENCED OTHER ASSOCIATED ADVERSE EVENTS, PATIENT SHIVERING, AND THE MEDICAL INTERVENTION WAS COLD BATH. WHILE USING ARCTIC SUN 5000 WITH PADS NEONATAL. ADDITIONALLY, A NURSE STATED THAT THE PATIENT EXPERIENCED OTHER ASSOCIATED ADVERSE EVENTS, PATIENT SHIVERING, AND THE MEDICAL INTERVENTION WAS, COLD BATH. WHILE USING ARCTIC SUN 5000 WITH PADS LARGE (L). ADDITIONALLY, A NURSE STATED THAT AN ADVERSE EVENT WAS EXPERIENCED AS A RESULT OF THE CHAIR SESSION, THIS BEING, PRESSURE ULCER WHILE USING ARCTIC SUN 5000 WITH PADS SMALL (S).

  Patient problems: Chills

  MAUDE report 25689703 ↗
• MalfunctionJun 26, 2026Inaccurate Flow Rate

  IT WAS REPORTED THAT THE ARCTIC SUN DEVICE GETTING AN ALARM THAT THE PATIENT CANNOT REACH GOAL TEMPERATURE. THEY SHOULD BE AT TARGET AT 825PM, BUT THE BABY WAS STILL 35.3C. THE WATER TEMPERATURE HAS BEEN DECREASING, CURRENTLY 36C. THEY HAVE AN ALARM 113 (REDUCED WATER TEMPERATURE CONTROL) IN THE EVENT LOG. THE FLOW WAS 0.5LPM, INLET PRESSURE WAS -6.9PSI, CIRCULATION PUMP COMMAND WAS 39 PERCENTAGE. PUMP HOURS WERE 1182.5. SYSTEM HOURS WERE 3209. THE REWARM OCCURS FROM 36.3C AT 0.5C/HR TO 36.5C. ASKED NURSE TO FEEL/LOOK FOR ANY KINKS, TWIST, COMPRESSION OR OCCLUSION OF THE PAD TUBING. UNABLE TO IDENTIFY ANY. THE NURSE DISCONNECTED THE PAD, ROTATED THE CONNECTORS AND RECONNECTED THE PAD USING PROPER TECHNIQUE. FLOW REMAINED LOW AT 0.6LPM. PER FOLLOW UP INFORMATION RECEIVED VIA TASK ON (B)(6) 2026, SPOKE WITH CHARGE NURSE WHO CONFIRMED PAD HAD BEEN EXCHANGED FOR A NEW ONE, AND FLOW RATE WENT UP SIGNIFICANTLY. THE WATER TEMPERATURE ALSO ROSE SO THE PATIENT WAS ABLE TO REACH THE TARGET TEMPERATURE AND MAINTAIN UNTIL THERAPY COMPLETED. THE ORIGINAL PAD HAD BEEN DISCARDED WITH BIOHAZARDOUS WASTE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25641982 ↗
• MalfunctionJun 25, 2026Inaccurate Flow Rate

  IT WAS REPORTED THAT ARCTIC SUN DEVICE IS ALARMING LOW FLOW (ALARM 02) AND THERAPY HAS SHUT OFF. THEY CHANGED THE ORIENTATION OF THE TUBING. THE NURSE STATED THE FLOW DROPPED TO 0 LPM, SO GOING TO CHANGE THE PAD OUT. NURSE STATED THAT THE FLOW WAS 0 LPM, INLET PRESSURE WAS -7PSI, CIRCULATION PUMP COMMAND WAS 34 PERCENTAGE. THE FLOW WAS 1.8 LPM, -7.3PSI, 73 PERCENTAGE. PUMP HOURS WERE 1263. SYSTEM HOURS WERE 4480. FLOW DROPPED TO 1.1 LPM AND INLET PRESSURE WAS -7.8 PSI. THERE WAS ALARM 113 (REDUCED WATER TEMPERATURE CONTROL) IN THE EVENT LOG. NURSE CONFIRMED THAT PADS WERE CONNECTED PROPERLY AND MOVED THE TUBING AROUND. THE FLOW WAS 0.8LPM, -7.1PSI. IF THE FLOW DROPPED TO 0.5LPM, THE HEATER WOULD NOT BE ABLE TO WORK APPROPRIATELY, LEADING TO ALARM 113. WALKED THE NURSE THROUGH REPLACING THE PAD. THE FLOW WITH NEW PAD WAS 0.9 LPM, -7.3PSI, 33 PERCENTAGE. NURSE REMOVED THE FLUID DELIVERY LINE AND INLET PRESSURE DROPPED TO 0 LPM. REPLACED THE FLUID DELIVERY LINE 0.9 LPM, -7PSI, 36 PERCENTAGE. ASKED THE NURSE TO KEEP AN EYE OF FLOW RATE AND TO CALL BACK IF IT DROPS AGAIN. PER FOLLOW UP INFORMATION RECEIVED ON 22JUN2026, NURSE STATED THAT THE FLOW HAD DROPPED BACK DOWN TO ZERO AGAIN. THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25630814 ↗
• InjuryJun 16, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT HARD MATERIAL IN THE ARCTIC GEL PAD THAT EASILY CAUSES PRESSURE SORES IN THE ARMPITS.

  Patient problems: Pressure Sore/Ulcer; Ulcer

  MAUDE report 25522333 ↗
• MalfunctionJun 1, 2026Inaccurate Flow Rate

  IT WAS REPORTED THAT THEY WERE TRYING TO INITIATE THERAPY BUT KEEP GETTING AIR LEAK AND NO FLOW IN AN ARCTIC SUN DEVICE. NURSE NOTED THAT THE ARCTIC GEL PAD LINE OR TUBING WAS NOT FULLY CONNECTED AT THE CLAMP. ADVISED SWAPPING OUT TO A NEW SET OF PADS. AIR OPENINGS IN THE LINE WOULD AFFECT THE FLOW RATE. PLACE THESE PADS ASIDE AND THE TM WILL FOLLOW UP AND ASSIST WITH HAVING THEM RETURNED FOR INVESTIGATION. PER FOLLOW UP INFORMATION RECEIVED VIA TASK ON 28MAY2026, SPOKE WITH CHARGE NURSE WHO CONFIRMED PADS ARE IN OFFICE. THEY DID NOT HAVE ANY DETAILS REGARDING THE PATIENT EVENT AND NOTED THEY HAD SPOKEN WITH THEIR REPRESENTATIVE ABOUT THE PAD AND WAS TOLD TO KEEP IT UNTIL SOMEONE CALLS TO COLLECT IT OR THE REPRESENTATIVE PICKS IT UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25356254 ↗
• MalfunctionMay 11, 2026Inaccurate Flow Rate

  IT WAS REPORTED THAT THEY WERE GETTING ALARM 02 (LOW FLOW) IN AN ARCTIC SUN DEVICE. FLOW RATE WAS 0.5 TO 0.8LPM, INLET PRESSURE (IP) WAS -7PSI, CIRCULATION PUMP COMMAND (CPC) WAS 34 PERCENTAGE, PUMP HOURS WERE 3561.4 AND SYSTEM HOURS WERE 2056. ASKED NURSE TO TRY TO IDENTIFY IF THE PAD TUBING WAS COMPRESSED OR KINKED ANYWHERE. THEY FOUND ONE LOCATION WHERE THE TUBING MEETS THE PAD BUT WAS UNABLE TO OPEN IT UP. FLOW REMAINS BETWEEN 0 TO 0.9 LPM. PATIENT AT TARGET 33.5C. ASKED NURSE TO WATCH PATIENT TEMPERATURE AND FLOW RATE. IF THE FLOW RATE DECREASES THE HEATER WOULD NOT BE ABLE TO PERFORM AT FULL CAPACITY. IF THE WATER TEMPERATURE DID NOT INCREASE AS EXPECTED OR IF THEY RECEIVE ALARM 113 (REDUCED WATER TEMPERATURE CONTROL), REPLACE THE PAD. PER FOLLOW UP INFORMATION RECEIVED VIA TASK ON 07MAY2026, SPOKE WITH CHARGE NURSE WHO CONFIRMED PAD WAS EXCHANGED BECAUSE THEY COULD NOT KEEP A STABLE FLOW RATE. PAD WAS A SINGLE NEONATE PAD AND HAS BEEN RETAINED IN OFFICE AT THE MOMENT. REQUESTED A BOX.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25144100 ↗
• MalfunctionApr 15, 2026Inaccurate Flow Rate

  IT WAS REPORTED THAT THE NURSE STATED THEY WERE JUST STARTING THERAPY ON A BABY AND ARE GETTING A LOW FLOW ALARM 02 (LOW FLOW) IN AN ARCTIC SUN DEVICE. CONFIRMED THEY WERE USING A NEONATE PAD. HAD NURSE STOP THERAPY AND EMPTY PAD. HAD NURSE DISCONNECT PAD AND STRAIGHTEN TUBING. INFORMED NURSE TO RECONNECT THE PADS WITH PROPER TECHNIQUE. HAD NURSE RESUME THERAPY, AFTER A FEW MINUTES WATER FLOW RATE (WFR) WAS 0.9 L/MIN AND NO ALARMS. DISCUSSED FLOW RATE AND CORRELATION TO HEATER FUNCTION, RECOMMENDED THEY KEEP AN EYE ON THE FLOW RATE AND CALL BACK WITH ANY ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24890280 ↗
• MalfunctionApr 15, 2026Inaccurate Flow Rate

  IT WAS REPORTED THAT THE IN THE LAST 10 TO 15 MINUTES THEY GOT A LOW FLOW ALERT (02) IN AN ARCTIC SUN DEVICE. THEY CHECKED THE CONNECTIONS BUT COULD NOT GET THE FLOW RATE TO INCREASE. FLOW WAS 0.7LPM. FLOW WAS 0.7LPM, INLET PRESSURE (IP) WAS NEGATIVE 7.0PSI, CIRCULATION PUMP COMMAND (CPC) WAS 35 PERCENTAGE, PUMP HOURS WERE 2354.5 AND SYSTEM HOURS WERE 2425.5. ASKED NURSE TO FEEL FOR ANY KINKS OR FLAT SECTIONS IN THE PAD TUBING. THEY WERE ABLE TO FIND ONE SECTION THAT WAS FLAT. WHEN THEY SQUEEZE IT OPEN, IT GOES FLAT AGAIN. FLOW WAS 0.8LPM. BABY AT TARGET. SUGGESTED CONTINUING TO ATTEMPT TO KEEP THAT SECTION OF THE TUBING OPEN AND MONITORING FLOW RATE. IF THE FLOW RATE DROPS MORE, REPLACE PAD AS THE HEATER WOULD NOT BE ABLE TO WORK AT FULL CAPACITY. PER FOLLOW UP INFORMATION RECEIVED VIA PHONE ON (B)(6) 2026, SPOKE WITH CHARGE NURSE WHO STATED THEY DECIDED TO EXCHANGE THE INFANT PAD FOR A NEW ONE BECAUSE THE TUBE CONTINUED TO DEFLATE. THE FLOW RATE CONTINUED TO DROP DUE TO THE FLATTENING OF THE TUBE, AND THEY WERE CONCERNED IT WOULD NOT WORK IN REWARM MODE. THE NEW PAD WORKED WITHOUT ISSUE AND THERAPY COMPLETED. REQUESTED A SAMPLE COLLECTION BOX.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24889518 ↗
• MalfunctionApr 15, 2026Inaccurate Flow Rate

  IT WAS REPORTED THAT THE WATER FLOW RATE DROPPED BELOW 1.1LPM SO THEY STOPPED THERAPY AND REFILLED THE RESERVOIR. NOW THEY ARE GETTING ALARM 02 (LOW FLOW) AND THE FLOW RATE WAS 0.6LPM IN AN ARCTIC SUN DEVICE S/N: (B)(6). FLOW RATE (FR) WAS 0.5LPM, INLET PRESSURE (IP) WAS NEGATIVE 6.9PSI, CIRCULATION PUMP COMMAND (CPC) WAS 26%, PUMP HOURS 669.3, SYSTEM HOURS 726.9. DEVICE SHOWS LOW AIR LEAK NOW. PATIENT DOWN TO 33.2C. NURSE WANTS TO KNOW IF THEY NEED TO ADD MORE WATER. EXPLAINED THE DEVICE WILL ALARM IF THE RESERVOIR WAS EMPTY. EXPLAINED CAUSES OF LOW FLOW. ASKED NURSE TO FEEL FOR ANY KINKS OR COMPRESSION OF THE PAD TUBING. NURSE WAS ABLE TO IDENTIFY A KINK. FLOW NOW 0.9LPM. ADVISED WATCHING THE FLOW RATE. IF THE FLOW DROPS TO 0.5 TO 0.6LPM AND THEY CANNOT GET IT TO INCREASE, REPLACE THE PAD. PER FOLLOW UP INFORMATION RECEIVED VIA PHONE ON 13APR2026, TRANSFERRED TO THE 5TH FLOOR NICU. SPOKE WITH NURSE WHO CONFIRMED NO FURTHER ISSUES AFTER TROUBLESHOOTING. THE FLOW DID REMAIN UNDER 1.1 LPM, BUT THE AIR LEAK MESSAGE DISAPPEARED AFTER ADJUSTING THE KINK IN THE PAD TUBING. PAD WAS DISPOSED OF AFTER THERAPY COMPLETED AND DEVICE REMAINED IN SERVICE. NEITHER THE DEVICE NOR PAD WERE INDIVID

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24889517 ↗
• MalfunctionApr 10, 2026Inaccurate Flow Rate

  IT WAS REPORTED THAT THE ARCTIC SUN DEVICE WAS ALARMING LOW FLOW, THE WATER FLOW RATE (WFR) WAS BETWEEN 0.6 TO 1 L/MIN. ONE OF THE CONNECTIONS HAS BUBBLES. NURSE STATED THEY HAD EACH PAD CONNECTED TO A DIFFERENT LEG OF THE FDL; THEY TRIED MOVING THEM TO THE SAME ONE, BUT THIS DID NOT HELP. HAD NURSE PAUSE THERAPY, EMPTY THE PAD, AND DISCONNECT PAD. NURSE CONFIRMED THERE WERE NO KINKS IN TUBING. HAD NURSE RECONNECT PAD WITH PROPER TECHNIQUE. NURSE RESUMED THERAPY. NURSE NOTICED A HISSING/LEAK SOUND COMING FROM THE PAD. NURSE WILL SWAP THE PAD OUT AND WILL CALL BACK IF THEY CONTINUE TO HAVE ISSUES. UNABLE TO GET S/N BEFORE NURSE HUNG UP. PER FOLLOW UP INFORMATION RECEIVED VIA PHONE ON 07APR2026, TRANSFERRED TO THE NICU. SPOKE WITH CHARGE NURSE WHO NOTED TWO NEONATE PADS HAD BEEN USED ON THIS PATIENT AND PADS WERE OVERLAPPED. THEY NOTED THE PATIENT HAD SOME EXPOSED SKIN SO TWO PADS HAD TO BE USED. THEY CONFIRMED ONLY ONE OF THE PADS SEEMED FAULTY AT THE TIME, SO THEY ONLY EXCHANGED ONE OF THE TWO PADS. THEY BELIEVE THE PAD HAD BEEN EXPOSED OF. THERE WAS NO RECORD OF RETENTION, AND THEY HAVE NOT SEEN IT STORED ANYWHERE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24839747 ↗
• MalfunctionMar 20, 2026Inaccurate Flow Rate

  IT WAS REPORTED THAT THEY SPOKE WITH THEM. ARCTIC SUN DEVICE S/N (B)(6) GAVE A LOW FLOW ALARM AND THERAPY STOPPED. THEY HAVE SINCE RESUMED THERAPY. CURRENTLY FLOW RATE WAS 0.8LPM, INLET PRESSURE (IP) WAS -7.0PSI, CIRCULATION PUMP COMMAND (CPC) WAS 34%. PUMP HOURS 1013.5, SYSTEM HOURS 2919.8. THEY HAVE A NOTE THAT SAYS TO CALL IF THE FLOW WAS BELOW 1.2LPM. THEY WERE ASKING WILL LOW FLOW AFFECT THE PATIENT'S ESOPHAGEAL TEMPERATURE READING. ASKED NURSE TO FEEL FOR ANY KINKS OR PAD TUBING COMPRESSION. NURSE STATED THEY ALREADY CHECKED AND THERE WERE NONE. STATED THEY HAD LOW FLOW WITH OTHER PATIENTS RECENTLY. CONFIRMED THE LOW FLOW RATE WILL NOT ALTER THE PATIENT'S ESOPHAGEAL PROBE TEMPERATURE READING. SUGGESTED KEEPING AN EYE ON THE FLOW RATE. IF IT DROPS FURTHER REPLACE PAD. LOT NGKW0105. ASKED TO SAVE THE PAD IF THEY SWAP IT OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24649202 ↗
• MalfunctionMar 13, 2026Inaccurate Flow Rate

  IT WAS REPORTED THAT THE LOW FLOW AND FLOW SHOW FOR AIR LEAKAGE. THE WATER TUBE FROM ARCTIC GEL PADS HAD A TAPERED PART THAT WAS DEVIANT. THEY HAVE PHOTOS. DURING USE AND NO INCIDENT FOR THE PATIENT. PER FOLLOW UP INFORMATION RECEIVED VIA MAIL ON 10MAR2026, LOT NUMBER UPDATED. SAMPLE IS AVAILABLE FOR INVESTIGATION (USED). THE INFORMATION WAS CORRECT. THEY WOULD LIKE TO ADD THAT THE REPORTED ISSUE CONTAINS A KINK IN ONE OF THE WATER SUPPLY TUBES. THE KINK WAS DIRECTLY UNDERNEATH THE CONNECTION POINT BETWEEN THE HOSE AND THE WHITE PLASTIC INLET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24599133 ↗
• MalfunctionMar 13, 2026Inaccurate Flow Rate

  IT WAS REPORTED THAT THE NEONATAL INTENSIVE CARE UNIT (NICU) NURSE STATED THE FLOW RATE WAS 0.9LPM. DEVICE WAS ALERTING LOW FLOW (02). GUIDED TO DIAGNOSTICS SHOWED THAT THE SYSTEM HOURS WERE 2553, PUMP HOURS WERE 2360, INLET PRESSURE (IP) WAS -7PSI, CIRCULATION PUMP COMMAND (CPC) WAS 33 PERCENTAGE, FLOW RATE (FR) WAS 0.9LPM. THEY CONFIRMED TUBING WAS STRAIGHT. ADVISED TO CALL BACK IF FLOW RATE (FR) DROPPED BELOW 0.7LPM. EXPLAINED CORRELATION BETWEEN HEATER CAPACITY AND FLOW RATE. PER FOLLOW UP INFORMATION RECEIVED VIA TASK ON 10MAR2026, SPOKE WITH CHARGE NURSE WHO CONFIRMED PATIENT COMPLETED THERAPY WITH THE SAME NEONATE SIZE PAD. IF AROUND 0.7 LPM WAS THE APPROPRIATE FLOW RATE FOR A NEONATE PAD BECAUSE HAS SEEN FLOW UP TO 3.0 LPM. EXPLAINED THE EXPECTED FLOW RATE FOR A NEONATE PAD SHOULD BE 1.0 BUT THAT THE HEATER WOULD CONTINUE TO ENGAGE IF IT WAS ABOVE 0.5 LPM. REQUESTED TM BE NOTIFIED TO SEND ALL THE NEONATE PAD CALLS FROM THE PAST 12 MONTHS. PAD WAS DISPOSED OF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24594108 ↗
• MalfunctionFeb 25, 2026Inaccurate Flow Rate

  IT WAS REPORTED THAT THEY TRYING TO COOL PATIENT AND ARCTIC SUN DEVICE WAS ALERTING 113 REDUCED WATER TEMPERATURE CONTROL. PATIENT TEMPERATURE (PT) WAS 33.2C, TARGETED TEMPERATURE (TT) WAS 33.5C, WATER TEMPERATURE (WT) WAS 27.2C, WATER FLOW RATE (WFR) WAS 0.4 L/M. NEONATAL PADS IN PLACE WITH WATER FLOW RATE (WFR) WAS 0.4 L/M. ADVISED THAT THEY NEED TO GET THE WATER FLOW RATE (WFR) UP FOR THE DEVICE TO BE ABLE TO EFFECTIVELY WARM DEVICE. WALKED THROUGH STOP THERAPY, DISCONNECT AND RECONNECT PADS. RESTARTED THERAPY AND WATER FLOW RATE (WFR) STABILIZED AT 0.5 L/M/. NURSE NOTED ONE SIDE OF THE TUBING WAS COLLAPSED ON THE LEFT SIDE. ADVISED TO SWAP OUT TO A NEW SET OF PADS. SN (B)(6). PER FOLLOW UP INFORMATION RECEIVED VIA PHONE ON 19FEB2026, SPOKE WITH NURSE WHO CONFIRMED PAD HAS BEEN RETAINED AT THE DESK. NO FURTHER ISSUES WITH SECOND PAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24445378 ↗
• MalfunctionFeb 25, 2026Inaccurate Flow Rate

  IT WAS REPORTED THAT NICU NURSE GETTING ALERT 113 (REDUCED WATER TEMP CONTROL) IN AN ARCTIC SUN DEVICE. PATIENT TEMPERATURE (PT) WAS 33.2C, TARGETED TEMPERATURE (TT) WAS 33.5C, WATER TEMPERATURE (WT) WAS 29.6C, FLOW RATE (FR) WAS 0.2LPM. EXPLAINED THE CORRELATION BETWEEN FLOW RATE AND HEATER CAPACITY. THE TUBING WAS LOOPED SO WE ADJUSTED THE TUBING AND DISCONNECTED THE PADS THEN RECONNECTED USING PROPER TECHNIQUE. FLOW RATE (FR) SETTLED AT 0.9LPM. GUIDED TO DIAGNOSTICS: SYSTEM HOURS 1939, PUMP HOURS 1824, INLET PRESSURE (IP) WAS -7PSI, CIRCULATION PUMP COMMAND (CPC) WAS 100%, FLOW RATE (FR) WAS 0.9LPM. THEY WILL CALL BACK IF THEY HAVE ANY OTHER ISSUES. PER FOLLOW UP INFORMATION RECEIVED VIA PHONE ON 17FEB2026, SPOKE WITH CHARGE NURSE WHO CONFIRMED PAD WAS NEONATE SIZE AND WAS USED THROUGH THE REMAINDER OF TREATMENT. THEY DID NOT RECALL ANY THERAPY MATERIALS BEING RETAINED FOR A RETURN. THEY WOULD DOUBLE CHECK. TOOK INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24442673 ↗
• MalfunctionFeb 23, 2026Inaccurate Flow Rate; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE PICU NURSE NOTES FLOW RATE (FR) WAS ONLY 0.9LPM AND THE ARCTIC SUN DEVICE WAS ALERTING 113 (REDUCED WATER TEMP CONTROL). GUIDED TO DIAGNOSTICS: SYSTEM HOURS 1818, PUMP HOURS 1649, INLET PRESSURE (IP) WAS -7PSI, CIRCULATION PUMP COMMAND (CPC) WAS 26%, FLOW RATE (FR) WAS 0.9LPM. ADJUSTED TUBING AND FLOW RATE (FR) DROPPED TO 0.7LPM. DISCONNECTED AND RECONNECTED TUBING USING PROPER TECHNIQUE. NO INCREASE IN FLOW RATE (FR) (FLUCTUATED FROM 0.4-0.7LPM). DISCONNECTED OLD PAD AND CONNECTED NEW PAD. FLOW RATE (FR) WAS 1.4LPM. OLD PAD NGKT2574. PLEASE CONTACT THE UNIT COORDINATOR FOR RETURN OF THIS PAD FOR INVESTIGATION. SECOND CALL FOR SAME PATIENT. THEY WERE AGAIN GETTING LOW FLOW AND ALERT 113 (REDUCED WATER TEMP CONTROL). FLOW RATE (FR) WAS 0.9LPM AND THEY WERE HESITANT TO MAKE ANY CHANGES, BUT THE PROVIDER ASKED TO CALL. EXPLAINED CORRELATION BETWEEN FLOW RATE AND HEATER CAPACITY. RATHER THAN TROUBLESHOOTING THIS PAD, THEY CONNECTED THE PREVIOUS PAD OFF TO THE SIDE TO INCREASE FLOW RATE WHICH SETTLED AT 1.8LPM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24422237 ↗
• MalfunctionFeb 23, 2026Inaccurate Flow Rate

  IT WAS REPORTED THAT THE PICU NURSE NOTES FLOW RATE (FR) WAS ONLY 0.9LPM AND THE ARCTIC SUN DEVICE WAS ALERTING 113 (REDUCED WATER TEMP CONTROL). GUIDED TO DIAGNOSTICS: SYSTEM HOURS 1818, PUMP HOURS 1649, INLET PRESSURE (IP) WAS -7PSI, CIRCULATION PUMP COMMAND (CPC) WAS 26%, FLOW RATE (FR) WAS 0.9LPM. ADJUSTED TUBING AND FLOW RATE (FR) DROPPED TO 0.7LPM. DISCONNECTED AND RECONNECTED TUBING USING PROPER TECHNIQUE. NO INCREASE IN FLOW RATE (FR) (FLUCTUATED FROM 0.4-0.7LPM). DISCONNECTED OLD PAD AND CONNECTED NEW PAD. FLOW RATE (FR) WAS 1.4LPM. OLD PAD NGKT2574. PLEASE CONTACT THE UNIT COORDINATOR FOR RETURN OF THIS PAD FOR INVESTIGATION. SECOND CALL FOR SAME PATIENT. THEY WERE AGAIN GETTING LOW FLOW AND ALERT 113 (REDUCED WATER TEMP CONTROL). FLOW RATE (FR) WAS 0.9LPM AND THEY WERE HESITANT TO MAKE ANY CHANGES, BUT THE PROVIDER ASKED TO CALL. EXPLAINED CORRELATION BETWEEN FLOW RATE AND HEATER CAPACITY. RATHER THAN TROUBLESHOOTING THIS PAD, THEY CONNECTED THE PREVIOUS PAD OFF TO THE SIDE TO INCREASE FLOW RATE WHICH SETTLED AT 1.8LPM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24422236 ↗
• MalfunctionFeb 18, 2026Inaccurate Flow Rate; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE NEONATAL INTENSIVE CARE UNIT (NICU) NURSE WAS STARTING TO REWARM BUT NOTED AN ALERT 113 (REDUCED WATER TEMP CONTROL) IN AN ARCTIC SUN DEVICE. FLOW RATE (FR) WAS 0.5LPM. EXPLAINED FLOW RATE (FR) WAS LIKELY CAUSING 113 ALERTS. NEED TO GET FLOW RATE (FR) UP TO 1LPM. GUIDED TO DIAGNOSTICS SHOWED THAT THE SYSTEM HOURS WERE 2750, PUMP HOURS WERE 2641, ADJUSTED TUBING AND RESTARTED THERAPY. NURSE NOTED THE TUBING APPEARS FLATTENED. LOT NUMBER WAS NGKT2574. DISCONNECTED THIS PAD AND CONNECTED A NEW ONE. INLET PRESSURE (IP) WAS -7PSI, CIRCULATION PUMP COMMAND (CPC) WAS 46 PERCENTAGE, FLOW RATE (FR) WAS INITIALLY 0.9LPM, BUT DROPPED TO 0.3LPM. ADJUSTED TUBING AND MOVED PAD CONNECTORS TO DIFFERENT PORTS, BUT FLOW RATE (FR) WOULD NOT INCREASE. ADDED A SECOND PAD OFF TO THE SIDE AND FLOW RATE (FR) WAS INCREASED TO 2LPM. THEY PLACED ME ON SPEAKER AND MOVED BABY TO NEW PAD AND REMOVED OLD PAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24379023 ↗
• MalfunctionFeb 12, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE ARCTIC SUN BLANKET (GEL PAD) IN NICU 9 STARTED LEAKING, THEY CHANGED IT OUT AND KEPT THE BLANKET AND WRAPPER AT THE CHARGE DESK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24324373 ↗
• MalfunctionFeb 12, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE ARCTIC SUN DEVICE ALARMING 64 NON-RECOVERABLE SYSTEM ERROR. POWERED OFF AND BACK ON. RESTARTED THERAPY WITH NO FURTHER ISSUES. CHARGE NURSE NOTED THAT THEY DID HAVE TO CHANGE THE PADS EARLIER BECAUSE OF LEAKING AND SAVED THE PADS FOR EVALUATION. NOTED TO FOLLOW UP WITH THE TM WHO CAN ASSIST WITH SENDING IN THE ARCTIC GEL PADS FOR INVESTIGATION. PER FOLLOW UP INFORMATION RECEIVED VIA TASK ON 02FEB2026, SPOKE TO CHARGE NURSE WHO CONFIRMED PADS WERE STILL AVAILABLE AND DEVICE HAS REMAINED IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24324367 ↗
• MalfunctionFeb 12, 2026Inaccurate Flow Rate

  IT WAS REPORTED THAT THE NEONATE REWARMING. THE ARCTIC SUN DEVICE WAS ALERTING 113 REDUCED WATER TEMPERATURE CONTROL. PATIENT TEMPERATURE (PT) WAS 36C, TARGETED TEMPERATURE (TT) WAS 36.5C. CONFIRMED THEY ADDED WATER EARLIER IN THE MORNING. PATIENT TEMPERATURE (PT) WAS 36C, TARGETED TEMPERATURE (TT) WAS 36.5C, WATER TEMPERATURE (WT) WAS 23.1C, WATER FLOW RATE (WFR) WAS 1.3 L/M. SYSTEM DIAGNOSTICS SHOWED THAT THE OUTLET MONITOR TEMPERATURE (T1) WAS 23.7C, OUTLET CONTROL TEMPERATURE (T2) WAS 23.5C, INLET TEMPERATURE (T3) WAS 23.8C, CHILLER TEMPERATURE (T4) WAS 7.3C, WATER FLOW RATE (WFR) WAS 0.9 L/M, INLET PRESSURE (IP) WAS -7PSI, CIRCULATION PUMP COMMAND (CPC) WAS 38 PERCENTAGE, MIXING PUMP COMMAND (MPC) WAS 0, HEATER 69 PERCENTAGE, WATER RESERVOIR LEVEL (WRL) WAS 5, SYSTEM HOURS WERE 2395.6 AND PUMP HOURS WERE 2161.9. WALKED THROUGH STOP THERAPY, EMPTY PADS AND DEVICE ALERTED EMPTY PADS NOT COMPLETED. SELECTED EMPTY PADS AGAIN. HAD DRAIN 16 OUNCES OF WATER FROM RIGHT DRAIN PORT. RESTARTED THERAPY AND WATER FLOW RATE (WFR) WAS 1 L/M. ADVISED WOULD CALL BACK IN 30 MINUTES TO CHECK ON WATER TEMPERATURE (WT). CALLED BACK AND WATER FLOW RATE (WFR) WAS DROPPED TO 0.6 L/M AND THEN 0. ADVIS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24324365 ↗