Arctic Sun® Temperature Management System, ArcticGel™ Pads 31709Recalls & reported problems

Summary

The FDA's MAUDE database contains 79 adverse event reports that list this exact device (DI 00801741080104), received between Sep 24, 2021 and Sep 29, 2026 — classified as 8 injuries, 71 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (18 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 25 most recent of 79 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50940522 ↗
• InjurySep 11, 2026Patient Device Interaction Problem

  Patient problems: Localized Skin Lesion; Skin Discoloration

  MAUDE report 50741618 ↗
• InjuryApr 22, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT THE BEDSIDE STAFF REFERENCING SKIN ABRASION ON A BARIATRIC PATIENT WITH EXCESS SKIN/ADIPOSE. UNDER BREASTS AND ARMPITS/GROIN DUE TO BLUNT/ROUGH EDGES OF ARCTIC GEL PAD. MEDICAL TREATMENT DONE BY HCP, WOUND CARE/PADDING REQUIRED. PER FOLLOW UP INFORMATION RECEIVED VIA MAIL ON 21APR2026, THERE WERE NO PHOTOS OR PRODUCT AVAILABLE, AND THE NURSES' USED DRESSINGS ON THE PATIENTS ABRADED SKIN.

  Patient problems: Abrasion

  MAUDE report 24958739 ↗
• MalfunctionApr 17, 2026Inaccurate Flow Rate

  IT WAS REPORTED THAT THE NURSE STATED THEY STARTED THERAPY THIS MORNING. THE ARCTIC SUN DEVICE WAS ALARMING LOW FLOW 01/02 AND CURRENT WATER FLOW RATE (WFR) WAS 0.2 L/MIN. THEY HAVE MADE SURE THE TUBING WAS STRAIGHT AND TRIED CONNECTING PADS TO A DIFFERENT PORT. CONFIRMED THEY WERE USING LARGE PADS. NURSE EMPTIED PADS AND DISCONNECTED, INFORMED NURSE TO RECONNECT WITH PROPER TECHNIQUE. RESUMED THERAPY, PADS PRIMED TO WATER FLOW RATE (WFR) WAS 0. HAD NURSE STOP, EMPTY PADS, AND DISCONNECT PADS. DEVICE ALARMED 07, EMPTY PADS NOT COMPLETE. NURSE DISCONNECTED OVER A CONTAINER. WALKED THROUGH ENABLING MANUAL CONTROL AND STARTED. DIAGNOSTICS SHOWED THAT THE WATER FLOW RATE (WFR) WAS 1.8 L/MIN, INLET PRESSURE (IP) WAS -7.2PSI, CIRCULATION PUMP COMMAND (CPC) WAS 47 PERCENTAGE, SYSTEM HOURS 1,413, PUMP HOURS 0. ADDED LEFT LEG PAD WATER FLOW RATE (WFR) WAS 2.1 L/MIN, INLET PRESSURE (IP) WAS -5.5 PSI, AND CIRCULATION PUMP COMMAND (CPC) WAS 65 PERCENTAGE. ADD RIGHT LEG WATER FLOW RATE (WFR) WAS 2 L/MIN, INLET PRESSURE (IP) WAS -6.6 PSI, AND CIRCULATION PUMP COMMAND (CPC) WAS 65 PERCENTAGE. ADDED RIGHT CHEST PAD WATER FLOW RATE (WFR) WAS 2.2 L/MIN, INLET PRESSURE (IP) WAS -6.3PSI, AND CIRCULATI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24918009 ↗
• MalfunctionApr 11, 2026Material Separation

  IT WAS REPORTED THAT THE ARCTIC GEL PAD DEHISCED FROM FOAM. CASE SUMMARY (PARTIALLY VERIFIED): SOURCE: NOTES-BASED, PRIMARY NURSE UNAVAILABLE. PATIENT ARRIVAL: (B)(6); (07:20¿09:00, TO CONFIRM). PROCEDURE: BELOW KNEE AMPUTATION. THERAPY DURATION: 36 HOURS. PHASE: REWARMING. OBSERVATIONS INCLUDED PADS APPEARED NORMAL AT APPLICATION (UNCONFIRMED), GEL DEHISCENCE/SEPARATION OBSERVED LATE IN THERAPY (30+ HRS), AND RESIDUE NOTED ON PATIENT SKIN. CLINICAL OUTCOME: PATIENT NOT HARMED AND NO ADVERSE OUTCOME REPORTED. ENVIRONMENTAL/USE FACTORS: NO KNOWN CONTRIBUTORS, NO CLEANING AGENTS, NO CONTAMINATION (BLOOD, URINE, FECES), REPORTED NORMAL DIAPHORESIS. PHYSICAL EVIDENCE: PADS DISCARDED BY HOUSEKEEPING AND NO SAMPLE RETAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24850147 ↗
• MalfunctionMar 15, 2026Inaccurate Flow Rate

  IT WAS REPORTED THAT THE NURSE STATED THAT THERE WAS A MESSAGE ON THE SCREEN READING LOW OR MARGINAL FLOW. GUIDED TO DIAGNOSTICS SHOWED THAT THE SYSTEM HOURS WERE 9366, PUMP HOURS WERE 8001, INLET PRESSURE (IP) WAS -7PSI, CIRCULATION PUMP COMMAND (CPC) WAS 60 PERCENTAGE, FLOW RATE (FR) WAS 2.3LPM. CONFIRMED ATTEMPTED SOME TROUBLESHOOTING PRIOR TO PAGING WHICH MIGHT HAVE RESOLVED THE ISSUE. PATIENT WENT TO CT WITH PADS IN PLACE. FLOW RATE (FR) WAS SLOWLY DROPPING AS THEY WERE TALKING AND APPEARED STABLE AT 1.5LPM. THEY HAD SOME OPTIONS FOR TROUBLESHOOTING, COULD TRY THE PADS ON A SECOND DEVICE, COULD TROUBLESHOOT EACH PAD SEPARATELY TO TRY TO IDENTIFY WHICH ONES ARE POSSIBLY DAMAGED FROM CT, OR ALL PADS COULD BE REPLACED. THEY HAD SEVERAL THINGS TO DO AT THE TIME. EXPLAINED THAT PROVIDED THE FLOW RATE (FR) HAD REMAINED AT 1L OR ABOVE IT WOULD NOT IMPACT THERAPY AND EDUCATED ON CORRELATION BETWEEN FLOW RATE (FR) AND HEATER CAPACITY. THEY DECIDE TO DO THE TROUBLESHOOTING. ADVISED TO HOLD ONTO THE PADS IF DECIDES TO CHANGE THEM. PAD LOT NUMBER NGJZ2082.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24602043 ↗
• MalfunctionMar 13, 2026Inaccurate Flow Rate

  IT WAS REPORTED THAT THE ARCTIC SUN DEVICE WAS GIVING LOW FLOW. ALREADY SPOKE WITH REP AND TRIED BASIC TROUBLESHOOTING WITH PADS. NORMOTHERMIA ADULT PATIENT 4 PADS CONNECTED SIZE LARGE. WATER FLOW RATE (WFR) WAS 1.2 L/M. NORMOTHERMIA PATIENT TEMPERATURE (PT) WAS 38.4C, TARGETED TEMPERATURE (TT) WAS 36C, WATER TEMPERATURE (WT) WAS 5.4C, WATER FLOW RATE (WFR) WAS 1.2 L/M. WALKED THROUGH STOP THERAPY, EMPTY AND DISCONNECT PADS. PLACED IN MANUAL CONTROL AT 4C WITH NO PADS. SYSTEM DIAGNOSTICS: OUTLET MONITOR TEMPERATURE (T1) WAS 5.3C, OUTLET CONTROL TEMPERATURE (T2) WAS 5.3C, INLET TEMPERATURE (T3) WAS 6.5C, CHILLER TEMPERATURE (T4) WAS 4.7C, WATER FLOW RATE (WFR) WAS 1.1 L/M, INLET PRESSURE (IP) WAS -7PSI, CIRCULATION PUMP COMMAND (CPC) WAS 37%, MIXING PUMP COMMAND (MPC) WAS 100%, HEATER COMMAND (HC) WAS 0, WATER RESERVOIR LEVEL (WRL) WAS 5, SYSTEM HOURS WERE 3718, PUMP HOURS WERE 3067. ADDED BACK PADS WHILE IN MC AND WATER FLOW RATE (WFR) WAS 2.4 L/M. DISABLED MANUAL CONTROL WATER FLOW RATE (WFR) WAS 1.1 L/M. SN: (B)(6) SWAP OUT PADS. PER FOLLOW UP INFORMATION RECEIVED VIA PHONE ON 11MAR2026, SPOKE WITH NURSE WHO STATED THEY HAD TRIED CHANGING THE DEVICE FIRST SINCE THEY ALREADY HAD O

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24594584 ↗
• MalfunctionMar 4, 2026Inaccurate Flow Rate

  IT WAS REPORTED THAT THE NURSE STATED THEY'RE TRYING TO INITIATE THERAPY BUT KEEP GETTING LOW FLOW & AIR LEAK ALERTS. SWAPPED OUT ARCTIC SUN DEVICE AND PADS BEFORE CALLING. 4 PADS CONNECTED. WATER FLOW RATE (WFR) WAS 1.5 L/M. WALKED THROUGH STOP THERAPY, DISCONNECT, EMPTY PADS AND RECONNECT USING PROPER TECHNIQUE. RESTARTED THERAPY AND WATER FLOW RATE (WFR) STABILIZED AT 2.9 L/M. ENCOURAGED THEM TO CALL BACK IF ANY ALERTS RETURN. SN (B)(6). PER FOLLOW UP INFORMATION RECEIVED VIA PHONE ON 27FEB2026, SPOKE WITH CHARGE NURSE WHO STATED THEY HAD A BIOMED COME CHECK THE DEVICE BECAUSE THEY HAD MORE PATIENTS TO TREAT. THE DEVICE CHECKED OUT FINE, SO THEY ASSUMED IT WAS A PADS ISSUE. PADS CONFIRMED AS SIZE LARGE. THE BIOMED DID NOT TEST THEM. THE PADS WERE RETAINED IN A BAG. PROVIDED HOSPITAL ADDRESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24505654 ↗
• MalfunctionFeb 25, 2026Inaccurate Flow Rate

  IT WAS REPORTED NURSE STATED PATIENT WENT TO MRI EARLIER. SINCE RETURNING, THEY WERE HAVING FLOW RATE ISSUES ON THE ARCTIC SUN DEVICE. LARGE PADS IN USE, FLOW RATE (FR) WAS .04LPM. EXPLAINED CORRELATION BETWEEN FLOW RATE AND HEATER CAPACITY. GUIDED TO DIAGNOSTICS: SYSTEM HOURS 9127, PUMP HOURS 7483, INLET PRESSURE (IP) WAS -2.1PSI, CIRCULATION PUMP COMMAND (CPC) WAS 100%, FLOW RATE (FR) WAS 0.4LPM. DISCONNECTED AND RECONNECTED PADS USING PROPER TECHNIQUE. NO CHANGE IN VALUES, AND ALL THE CLAMPS HAVE A LOT OF BUBBLES IN THEM. THEY OPTED TO CHANGE THE SET OF PADS VS TEST EACH ONE. PAD LOT NGKUY601. PLEASE CALL AND ASK FOR CHARGE TO ARRANGE RETURN OF THE PADS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24442669 ↗
• MalfunctionFeb 19, 2026Nonstandard Device; Fitting Problem

  IT WAS REPORTED THAT THE ARCTIC GEL THIGH PAD CLEAR INPUTS WOULD NOT FIT INTO THE FLUID DELIVERY LINES. TOO BIG. IT ALMOST LOOKS LIKE THERE'S ADDITIONAL PLASTIC AROUND THE INPUT THAT CAUSED IT NOT TO FIT. THEY OPENED A NEW KIT, AND EVERYTHING WORKED FINE. PER FOLLOW UP INFORMATION RECEIVED VIA MAIL ON 12FEB2026, THE DEFECTIVE PAD WAS THE RIGHT LEG PAD. THEY HAD TO OPEN ANOTHER ENTIRE SET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24388977 ↗
• MalfunctionDec 16, 2025Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT THEY WERE HAVING TROUBLE GETTING THE PADS TO FILL. THEY FILLED THE RESERVOIR, RESTARTED THERAPY, AND STILL ARE NOT GETTING ANY FLOW. THEY ARE GETTING FLUID DELIVERY LINE (FDL) OPEN MESSAGE. FLOW RATE WAS 0LPM, INLET PRESSURE (IP) WAS -0.1PSI, CIRCULATION PUMP COMMAND (CPC) WAS 100 PERCENTAGE, PUMP HOURS WERE 139.1 AND SYSTEM HOURS WERE 3845. STOPPED THERAPY. DISCONNECTED PADS AND STARTED MANUAL MODE. WITH NO PADS CONNECTED, 1.8LPM, -6.8PSI, 56 PERCENTAGE. CONNECTED THE LEFT CHEST PAD. 0.4LPM, -0.1PSI, 100 PERCENTAGE. DISCONNECTED CHEST PAD. NURSE CONNECTED A UNIVERSAL PAD. IT WAS NOT ON THE PATIENT. THEY JUST BROUGHT IT IN TO TROUBLESHOOT WITH. 0.6LPM, -6.9PSI, 36 PERCENTAGE. CONNECTED LEFT THIGH PAD. 1.3LPM, -7.2PSI, 40 PERCENTAGE. CONNECTED RIGHT THIGH PAD. 2LPM, -7.2PSI, 53 PERCENTAGE. CONNECTED RIGHT CHEST PAD. 2.5LPM, -7.3PSI, 65 PERCENTAGE. RECONNECTED LEFT CHEST PAD AND INLET PRESSURE (IP) AND FLOW DROPPED TO 0. REMOVED LEFT CHEST PAD NGKR1122 AND ASKED NURSE TO PLACE IT BEHIND THE NURSE'S STATION FOR RETURN. DISABLED MANUAL MODE AND STARTED THERAPY. EXPLAINED COULD USE 1-2 UNIVERSAL PADS IN PLACE OF THE LEFT CHEST PAD IF IT OFFERS ADEQUATE BODY SURFACE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23822586 ↗
• MalfunctionDec 5, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT THE HYDROGEL DID NOT STAY INTACT, PEELED OFF WITH THE PLASTIC FILM IN AN ARCTIC GEL PAD. THE INCIDENT OCCURRED DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23728599 ↗
• MalfunctionOct 24, 2025Restricted Flow rate; Gas/Air Leak; Restricted Flow rate; Gas/Air Leak

  IT WAS REPORTED THAT WHEN OPENED THE ARCTIC GEL PAD, IT APPEARED NORMAL. HOWEVER, DURING USE WITH THE ARCTIC SUN MACHINE, THE SYSTEMS SHOWED A NO FLOW ALARM. UPON CHECKING, THEY FOUND THAT THE GEL PAD WAS PUNCTURED INTERNALLY AND COULD NOT MAINTAIN THE PRESSURE OF -7.0 PSI, RESULTING IN NO WATER FLOW THROUGH THE PAD, REFER TO THE ATTACHED VIDEO. THE ISSUE DETECTED DURING INSTALLATION. PER FOLLOW UP INFORMATION RECEIVED VIA TASK ON (B)(6) 2025, THE ISSUE DETECTED WHEN THEY HELPED APPLY TO PATIENT'S SKIN, AND THE MACHINE TRIGGER "LOW FLOW", THEN THE APPLICATION SPECIALIST FOUND OUT LEAKAGE WITH BUBBLE AS VIDEO ATTACHED. THEY CHANGED NEW GEL PAD, AND PATIENT WAS NOT IMPACTED. THERE WAS NO INJURY TO PATIENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23383086 ↗
• MalfunctionOct 16, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT THE ARCTIC GEL CAME OFF THE PAD WITH THE BACKING PAPER. THE INCIDENT OCCURRED BEFORE USE. WHEN REMOVING THE BACKING PAPER PRIOR TO PLACING THE PAD ON THE PATIENT THE HYDROGEL CAME AWAY FROM THE PAD WITH THE BACKING PAPER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23308870 ↗
• MalfunctionOct 15, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT THE ARCTIC GEL PAD HYDROGEL PEELED OFF THE PAD WITH THE LINER AND WAS NOT ABLE TO BE USED. HAD TO OPEN NEW PADS TO TREAT THE PATIENT. PAD COVERAGE WAS NOT APPROPRIATE WITH GEL PEELING OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23301116 ↗
• MalfunctionOct 10, 2025Inaccurate Flow Rate; Nonstandard Device; Inaccurate Flow Rate; Nonstandard Device

  IT WAS REPORTED THAT THE NURSE STATED THEY HAD BEEN TRYING TO INITIATE TTM AND HAD TRIED ALL OF THE TROUBLESHOOTING STEPS FOR THE FLOW RATE ALERT02) BUT HAD BEEN UNSUCCESSFUL. FLOW RATE (FR) WAS 0.5LPM. GUIDED TO SYSTEM DIAGNOSTICS, SYSTEM HOURS 8679, PUMP HOURS 7929, INLET PRESSURE (IP) WAS -2.6PSI, CIRCULATION PUMP COMMAND (CPC) WAS100 PERCENT. DISCONNECTED AND RECONNECTED PADS USING PROPER TECHNIQUE. NO CHANGE IN VALUES. THERAPY HAS BEEN ONGOING FOR ABOUT 36 HOURS. EXPLAINED ONE OR MORE OF THE PADS COULD HAVE BEEN DAMAGED AND THEY CAN TEST EACH PAD INDIVIDUALLY AND TRY TO DETERMINE WHICH ONE/ONES NEED TO BE REPLACED. THEY OPTED TO CHANGE THE WHOLE SET OF PADS. ADVISED PRODUCT COMPLAINTS MAY FOLLOW UP REGARDING GETTING THE PADS BACK FOR INVESTIGATION. PAD LOT NUMBER NGJU3967. NO FURTHER CALLS FROM THIS ACCOUNT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23268598 ↗
• MalfunctionSep 26, 2025Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT THE BIOMED TROUBLESHOOTING LOW FLOW ALERT02) WHILE ARCTIC SUN DEVICE WAS ON PATIENT. THEY WERE DRAINING THE PADS. HAD THEY CANCELLED THIS PROCESS AND RESTART. THE FLOW RATE (FR) WAS INITIALLY 1.8LPM BUT QUICKLY DROPPED TO 0.4LPM. GUIDED TO DIAGNOSTICS SCREEN SHOWED THAT THE SYSTEM HOURS WERE 2894, PUMP HOURS, INLET PRESSURE (IP) WAS -1.7PSI, CIRCULATION PUMP COMMAND (CPC) WAS 100 PERCENTAGE, FLOW RATE (FR) WAS 0.1LPM. DISCONNECTED AND RECONNECTED, BUT THEY CLAIM THE RIGHT THIGH PAD WILL NOT CONNECT TO ANY PORT. TRIED TO START AGAIN WITH JUST THREE PADS: INLET PRESSURE (IP) WAS -3.8PSI, CIRCULATION PUMP COMMAND (CPC) WAS 100 PERCENTAGE, FLOW RATE (FR) WAS 1.2LPM. ASKED IF THEY HAD ANOTHER DEVICE TO CHECK THESE PADS AGAINST AND STATED THAT DEVICE WAS ALSO ALERTING LOW FLOW. NURSE CONFIRMED PATIENT CAME IN AT 10PM LAST NIGHT AND HAS NOT LEFT THE ROOM. STOPPED THERAPY, DRAINED AND DISCONNECTED PADS AND PLACED DEVICE IN MANUAL CONTROL MANUAL WAS NOT DISABLED ON THIS DEVICE. JUST FLUID DELIVERY LINE (FDL) INLET PRESSURE (IP) WAS -7.1PSI, CIRCULATION PUMP COMMAND (CPC) 49 PERCENTAGE, FLOW RATE (FR) WAS 1.8LPM. ADDED RIGHT CHEST PAD, INLET PRESSURE (IP) WAS -0 PSI, CIR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23154928 ↗
• MalfunctionSep 24, 2025Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT THEY WERE TRYING TO INITIATE THERAPY USING ARCTIC SUN DEVICE S/N: (B)(6) BUT CANNOT GET THE PADS TO PRIME. ALSO, THERE WERE NO BLUE AND WHITE STICKERS ON THE CONNECTORS. FLOW 0LPM, INLET PRESSURE (IP) WAS -0.2PSI, CIRCULATION PUMP COMMAND (CPC) WAS 100%. PUMP HOURS 3200. SYSTEM HOURS 3500. EXPLAINED THE PADS WERE REDESIGNED AND NO LONGER CONTAIN THE BLUE AND WHITE STICKERS. THE PADS CAN NOW CONNECT IN EITHER ORIENTATION. STOPPED THERAPY, DISCONNECTED PADS AND STARTED MANUAL CONTROL. FLOW 2LPM, INLET PRESSURE (IP) WAS -7.0PSI, CIRCULATION PUMP COMMAND (CPC) WAS 64%. CONNECTED PADS ONE AT A TIME. RIGHT THIGH 0.9LPM, -7.0PSI, CIRCULATION PUMP COMMAND (CPC) WAS 42%. LEFT THIGH FLOW 2LPM, INLET PRESSURE (IP) WAS -7.0PSI, CIRCULATION PUMP COMMAND (CPC) WAS 50%. RIGHT CHEST FLOW 2LPM, INLET PRESSURE (IP) WAS -7.0PSI, CIRCULATION PUMP COMMAND (CPC) WAS69%. LEFT CHEST FLOW 0LPM, INLET PRESSURE (IP) WAS -0.2PSI, CIRCULATION PUMP COMMAND (CPC) WAS 100%. FLOW DID NOT IMPROVE WHEN THE LEFT CHEST PAD WAS MOVED TO ANOTHER VALVE SET. LOT#: NGJX2433. REMOVED LEFT CHEST PAD AND RESUMED THERAPY IN AUTOMATIC MODE. FLOW RATE WAS 1.6LPM. SUGGESTED PLACING A UNIVERSAL PAD OR TWO ON T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23134498 ↗
• MalfunctionSep 17, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THEY HAD THIS SIMILAR SITUATION HAPPEN RECENTLY ON A DIFFERENT ARCTIC SUN DEVICE. THEY REPLACED THE PADS AND WERE ABLE TO CONTINUE THERAPY LAST TIME. THERAPY WAS GOING WELL UNTIL THE PATIENT WENT TO CT. NOW, THEY ARE GETTING A FLUID DELIVERY LINE (FDL) OPEN MESSAGE, AND THE FLOW RATE WAS 0LPM, INLET PRESSURE (IP) WAS -1.1PSI, CIRCULATION PUMP COMMAND (CPC) WAS 100 PERCENTAGE. S/N (B)(6) ASKED NURSE TO STOP THERAPY, EMPTY AND DISCONNECT THE PADS. IN MANUAL MODE FLOW 1.7LPM, INLET PRESSURE (IP) WAS -7.0PSI, CIRCULATION PUMP COMMAND (CPC) WAS 47 PERCENTAGE, PUMP HOURS WERE 529 AND SYSTEM HOURS WERE 685. CONNECTED THE RIGHT THIGH PAD USING PROPER TECHNIQUE. 1.7LPM, INLET PRESSURE (IP) WAS -2.3PSI, CIRCULATION PUMP COMMAND (CPC) WAS 100 PERCENTAGE. MOVED TO ANOTHER VALVE SET AND GOT SIMILAR VALUES. REMOVED THE RIGHT THIGH PAD AND CONNECTED RIGHT CHEST PAD.1.9LPM, INLET PRESSURE (IP) WAS -2.0PSI, CIRCULATION PUMP COMMAND (CPC) WAS 100 PERCENTAGE. LOT NUMBER NGKR2375. REMOVED CHEST PAD AND CONNECTED UNIVERSAL PAD (NGKS0035). 2.2LPM, INLET PRESSURE (IP) WAS -3.0PSI, 100 PERCENTAGE. NURSE WOULD CHANGE OUT THE PADS. CALLED BACK 30 MINUTES LATER. THEY WERE TRYING TO LOCAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23080658 ↗
• MalfunctionSep 17, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT THEY HAD THIS SIMILAR SITUATION HAPPEN RECENTLY ON A DIFFERENT ARCTIC SUN DEVICE. THEY REPLACED THE PADS AND WERE ABLE TO CONTINUE THERAPY LAST TIME. THERAPY WAS GOING WELL UNTIL THE PATIENT WENT TO CT. NOW THEY ARE GETTING A FLUID DELIVERY LINE (FDL) OPEN MESSAGE, AND THE FLOW RATE WAS 0LPM, INLET PRESSURE (IP) WAS -1.1PSI, CIRCULATION PUMP COMMAND (CPC) WAS 100 PERCENTAGE. S/N (B)(6) ASKED NURSE TO STOP THERAPY, EMPTY AND DISCONNECT THE PADS. IN MANUAL MODE FLOW 1.7LPM, INLET PRESSURE (IP) WAS -7.0PSI, CIRCULATION PUMP COMMAND (CPC) WAS 47 PERCENTAGE, PUMP HOURS WERE 529 AND SYSTEM HOURS WERE 685. CONNECTED THE RIGHT THIGH PAD USING PROPER TECHNIQUE. 1.7LPM, INLET PRESSURE (IP) WAS -2.3PSI, CIRCULATION PUMP COMMAND (CPC) WAS 100 PERCENTAGE. MOVED TO ANOTHER VALVE SET AND GOT SIMILAR VALUES. REMOVED THE RIGHT THIGH PAD AND CONNECTED RIGHT CHEST PAD.1.9LPM, INLET PRESSURE (IP) WAS -2.0PSI, CIRCULATION PUMP COMMAND (CPC) WAS 100 PERCENTAGE. LOT NUMBER NGKR2375. REMOVED CHEST PAD AND CONNECTED UNIVERSAL PAD (NGKS0035). 2.2LPM, INLET PRESSURE (IP) WAS -3.0PSI, 100 PERCENTAGE. NURSE WOULD CHANGE OUT THE PADS. CALLED BACK 30 MINUTES LATER. THEY WERE TRYING TO LOCATE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23072204 ↗
• MalfunctionSep 5, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT THE GEL AND PAD WERE DETACHED AND THERE WERE BEADS FALLING OUT STICKING ON PATIENT'S SKIN. NURSE HAS TO PREMATURELY TERMINATE THE THERAPY DUE TO THE ARCTIC GEL PADS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22978008 ↗
• MalfunctionAug 29, 2025Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE NURSE STATED THAT THEY WERE GETTING LOW FLOW ALERTS (02). FLOW RATE (FR) WAS 0.9LPM WITH LARGE PADS IN PLACE. ASKED IF PATIENT HAS BEEN TO CT AND THEY STATED THAT THEY WERE ACTUALLY TAKING THEM TO CT VERY SHORTLY. GUIDED TO SYSTEM DIAGNOSTICS SHOWED THAT THE SYSTEM HOURS WERE 556, PUMP HOURS WERE 403, INLET PRESSURE (IP) WAS -3.6PSI, CIRCULATION PUMP COMMAND (CPC) WAS 100 PERCENTAGE. DISCONNECTED AND RECONNECTED TUBING USING PROPER TECHNIQUE AND THERE WAS NO CHANGE IN THE VALUES. CHECKED FLUID DELIVERY LINE (FDL) AND OBSERVED NO DAMAGE. BUBBLES IN ALL THE CLAMP CONNECTORS. ADVISED TO OFTEN SEE DAMAGE TO THE PADS DURING CT SO RATHER THAN TESTING OR REPLACING PADS NOW AND POTENTIALLY AGAIN LATER, WHEN THEY COME BACK FROM CT TRY CONNECTING ONE PAD AT A TIME. EXPLAINED HOW TO WATCH FOR INLET PRESSURE TO STABILIZE AT NEGATIVE 7. ADVISED THEY ARE WELCOME TO PAGE AGAIN UPON PATIENT'S RETURN BUT RECEIVED NO FURTHER CALLS DURING THE NIGHT. PAD LOT PER FOLLOW UP INFORMATION RECEIVED VIA TASK ON 11SEP2025, SPOKE WITH NURSE WHO STATED THE PATIENT DID GO TO CT AND AFTER RETURNING, THE FLOW RATE DID NOT RISE ABOVE 0.9 LPM. THE CHARGE NURSE ORDERED ONE CHEST PAD REPLACED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22926150 ↗
• InjuryAug 19, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT THE HYDROGEL SURFACE WAS REMOVED PRIOR TO USAGE CAUSING PATIENT SKIN DAMAGE. IT WAS DISCOVERED THAT THE PATIENT HAD A LARGE BLUISH AREA ON THE LEFT SIDE OF THE BACK, CONSISTENT WITH THE AREA WHERE THE ARCTIC GEL PADS WERE APPLIED. THE SKIN WAS LIKELY FROSTBITTEN. WHEN THE PADS WERE BEING APPLIED TO THE PATIENT, AND THE COLLEAGUE ATTEMPTED TO REMOVE THE PROTECTIVE FILM FROM THE UPPER BODY PAD (ON THE LEFT SIDE), THE HYDROGEL LAYER OF THE PRODUCT ALSO DETACHED. ONLY THE PATIENT'S BACK AND SIDE APPEAR TO HAVE SUSTAINED POSSIBLE FROSTBITE. INCIDENT OCCURRED DURING USE. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS REPORTED. PER ADDITIONAL INFORMATION RECEIVED VIA MAIL ON 04SEP2025, IN THIS CASE, ELECTRODES WERE PLACED ON THE PATIENT AND THE PATIENT SUSTAINED INJURIES. THE INJURIES HAVE HEALED ON THEIR OWN AND THE PATIENT HAS RECOVERED. IT WAS BOTH A PRODUCT DEFECT AS THE GEL WAS LOOSE AND A USER ERROR AS THESE DAMAGED ELECTRODES SHOULD NOT HAVE BEEN PLACED ON THE PATIENT. THE ENTIRE TREATMENT WAS DONE WITH THE SAME ELECTRODES, AND THE INJURY WAS NOT DISCOVERED UNTIL AFTER THE ARCTIC SUN TREATMENT WAS COMPLETED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Skin Discoloration

  MAUDE report 22843273 ↗
• MalfunctionAug 11, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A SET OF LARGE ARCTIC GEL PADS 3 OUT OF 4 OK, BUT THE ONE PAD WHEN THEY REMOVED THE BACKING, THE ADHESIVE LAYER ALSO CAME AWAY. GEL PEELED AWAY WITH BACKING FILM BEFORE USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22776556 ↗
• MalfunctionAug 4, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT THE (B)(6) HOSPITAL (B)(6), SD HAD EXPERIENCED A DEFECT WITH REFERENCE # 317-05 (LOT # NGJX2721) ARCTIC GEL PAD. WHEN THE NURSING STAFF WENT TO REMOVE THE WRAPPER ON THE STICKY PART OF THE PADS IT REMOVES THE ENTIRE STICKY PART OF THE PAD, MAKING THEM UNABLE TO USE. THEY HAVE THE PRODUCT AND PACKAGING SAVED FROM THIS. PLEASE LET THEM KNOW WHAT OTHER INFORMATION NEED FROM THEM. PER ADDITIONAL INFORMATION RECEIVED VIA MAIL ON 01AUG2025, THEY HAVE THE ONE ITEM THAT THEY REPORTED BACK ON JULY 16 (REF # 317-05). JUST YESTERDAY, THEY HAD AN ISSUE WITH A DIFFERENT SIZE PAD, BUT THE SAME ISSUE AS THE ONE REPORTED. THIS WAS REF # 317-09. WHEN THE STAFF REMOVED THE TAB, JUST THE TAB POPPED OFF. THE BLUE LAYER THAT WAS SUPPOSED TO PEEL OFF DID NOT PEEL OFF WITH THE TAB. THE STAFF TOOK ALL THE STICKY PART OFF AND USED THE REST OF THE PAD BUT HAD TO AFFIX TO PATIENT USING COBAN. THEY HAVE JUST THE STICKY PART AND TAB FROM THIS ITEM AS THE PAD ITSELF WAS CURRENTLY ON A PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22708454 ↗