Arctic Sun® Temperature Management System, ArcticGel™ Pads 31705Recalls & reported problems

Summary

The FDA's MAUDE database contains 90 adverse event reports that list this exact device (DI 00801741080067), received between Oct 23, 2020 and Sep 24, 2026 — classified as 5 injuries, 85 malfunctions.

The most frequently reported specific device problem is “Inaccurate Flow Rate” (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 90 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50889816 ↗
• InjuryJul 2, 2026Patient Device Interaction Problem

  IT WAS REPORTED BY CRITICAL CARE NURSES IN AN ONLINE SURVEY THAT A NURSE STATED THAT THE PATIENT EXPERIENCED OTHER ASSOCIATED ADVERSE EVENTS, LOCALIZED SKIN EFFECTS THERMAL DERMATITIS, HYDROGEL RELATED SKIN IRRITATION, PRESSURE RELATED INJURIES. SKIN IRRITATION, SKIN TEARS UNDER PADS. PATIENT SHIVERING, AND THE MEDICAL INTERVENTION WAS MEDICATION ADMINISTRATION INCREASED SEDATION, BAIR HUGGER PLACED ON TOP OF PATIENT WHILE COOLING, MAGNESIUM ADMINISTRATION. WHILE USING ARCTIC SUN 5000 WITH PADS SMALL (S). THE PATIENT DID HAVE DIABETES, PERIPHERAL VASCULAR DISEASE OR POOR NUTRITIONAL STATUS. THE PATIENT WAS ON STEROIDS OR HIGH DOSE VASOPRESSOR THERAPY.

  Patient problems: Chills; Skin Tears

  MAUDE report 25691306 ↗
• MalfunctionMay 20, 2026Missing Information

  IT WAS REPORTED THAT THE MANUFACTURE LABEL, WHICH SHOULD BE AFFIXED TO THE BOTTOM RIGHT OF THE PRODUCT, WAS MISSING IN AN ARCTIC GEL PAD. THE INCIDENT OCCURRED BEFORE USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25235804 ↗
• MalfunctionMay 11, 2026Inaccurate Flow Rate

  IT WAS REPORTED THAT THEY WERE GETTING ALARM 01 (PATIENT LINE OPEN) AND ALARM 02 (LOW FLOW) WHILE TRYING TO INITIATE THERAPY USING ARCTIC SUN DEVICE. FLOW RATE WAS 0LPM, INLET PRESSURE (IP) WAS -0PSI, CIRCULATION PUMP COMMAND (CPC) WAS 0 PERCENTAGE. DEVICE READS PRIMING. PUMP HOURS WERE 2102.1, SYSTEM HOURS WERE 2912.9. STOPPED THERAPY, EMPTIED AND DISCONNECTED PADS. INITIATED MANUAL CONTROL. FLOW RATE WAS 1.8LPM, INLET PRESSURE (IP) WAS -7.1PSI, CIRCULATION PUMP COMMAND (CPC) WAS 55 PERCENTAGE. CONNECTED RIGHT THIGH PADS. INLET PRESSURE (IP) WAS -4.4PSI. DISCONNECTED RIGHT THIGH PAD. CONNECTED RIGHT CHEST PAD. INLET PRESSURE (IP) WAS -1.9PSI. CONFIRMED NO VISIBLE DAMAGE TO PADS OR FLUID DELIVERY LINE (FDL). SUGGESTED REPLACING PADS AND PUTTING THIS SET BEHIND THE NURSING STATION FOR RETURN. LOT NGKY3272. PER FOLLOW UP INFORMATION RECEIVED VIA TASK ON 07MAY2026, SPOKE WITH CHARGE NURSE WHO CONFIRMED PAD REPLACEMENT WAS APPROVED BUT WAS NOT ATTENDING THIS PATIENT DURING THE ISSUE SO THEY COULD NOT CONFIRM IF THIS ACTION HAD BEEN COMPLETED OR IF IT RESOLVED ANY ISSUES. THERE WERE CURRENTLY NO PATIENTS ON AN ARCTIC SUN DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25144099 ↗
• MalfunctionFeb 20, 2026Inaccurate Flow Rate

  IT WAS REPORTED THAT THE PATIENT WAS PRONE. THEIR PATIENT HAS BEEN COOLING IN AN ARCTIC SUN DEVICE FOR ABOUT 6 HOURS. THEY WERE GETTING A LOW FLOW ALARM (ALARM 02). FLOW RATE (FR) WAS 0.5LPM, INLET PRESSURE (IP) WAS -6.8PSI, CIRCULATION PUMP COMMAND (CPC) WAS 40 PERCENTAGE. PUMP HOURS WERE 1503.8 AND SYSTEM HOURS WERE 4652. ADULT PATIENT WITH A SET OF FOUR PADS CONNECTED. ASKED NURSE TO LOOK FOR ANY KINKS, COMPRESSION, OR TWISTS IN THE TUBING. NONE NOTED. STOPPED THERAPY, EMPTIED AND DISCONNECTED PADS, AND STARTED MANUAL MODE. FLOW RATE (FR) WAS 1.9LPM, - INLET PRESSURE (IP) WAS 7.0PSI, CIRCULATION PUMP COMMAND (CPC) WAS 57 PERCENTAGE. CONNECTED LEFT THIGH PAD. FLOW RATE (FR) WAS 0.4LPM, INLET PRESSURE (IP) WAS -7.1PSI, CIRCULATION PUMP COMMAND (CPC) WAS 25 PERCENTAGE. CONNECTED TO THE LEFT CHEST PAD. FLOW RATE (FR) WAS 1.2LPM, INLET PRESSURE (IP) WAS -7.1PSI, CIRCULATION PUMP COMMAND (CPC) WAS 43 PERCENTAGE. CONNECTED LEFT THIGH PAD. FLOW RATE (FR) WAS 1.0LPM, INLET PRESSURE (IP) WAS -6.8PSI, CIRCULATION PUMP COMMAND (CPC) WAS 37 PERCENTAGE. MOVED TO ANOTHER POSITION ON THE FLUID DELIVERY LINE (FDL) AND FLOW DROPPED TO 0.6LPM, INLET PRESSURE (IP) WAS -7.0PSI. ASKED NURSE TO FEEL U

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24400343 ↗
• MalfunctionFeb 9, 2026Inaccurate Flow Rate; Fitting Problem

  IT WAS REPORTED THAT THE GEL ARCTIC GEL PAD WAS CONNECTED AND PATIENT USE WAS INITIATED; HOWEVER, NO FLOW WAS DETECTED. UPON CHECKING THE CONNECTION, THE TUBING AND CONNECTOR WERE FOUND TO BE DISCONNECTED. THE GEL PAD WAS SECURED WITH AN INSULOCK (CABLE TIE) AS A FIRST-AID MEASURE, AND IT WAS USED IN THAT CONDITION. PER FOLLOW UP INFORMATION RECEIVED VIA TASK ON 21JAN2026, SAMPLE WILL BE RETURNED AND LET KNOW THE TRACKING ID IN NEAR FUTURE. PHOTO SAMPLE WAS NOT PROVIDED, WILL LET KNOW IF IT IS ATTACHED LATER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24294716 ↗
• MalfunctionFeb 5, 2026Inaccurate Flow Rate; Nonstandard Device

  IT WAS REPORTED THAT THE FLOW RATE COULD NOT INCREASE, PRELIMINARY ASSESSMENT INDICATES A PATCH AIR LEAK. REPLACING ONE SET OF ARCTIC GEL PAD SHOULD RESOLVE THE ISSUE, WATER LEAKAGE. THE INCIDENT OCCURRED DURING USE. PER FOLLOW UP INFORMATION RECEIVED VIA TASK ON 02FEB2026, THE NUMBER OF PRODUCTS AFFECTED WAS ONE. NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24268772 ↗
• MalfunctionJan 28, 2026Restricted Flow rate; Component Misassembled

  IT WAS REPORTED THAT AFTER ATTACHING FOUR ARCTIC GEL PADS AND STARTING USE, WATER FAILED TO FLOW INTO THE LEFT THIGH PAD, THE CONNECTION POINT BETWEEN THE WATER INLET LINE AND THE PAD WAS NOT FILLED WITH WATER DUE TO THE INLET CONNECTION NOT FILLING, AND CIRCULATION DID NOT OCCUR EVEN WHEN TESTED INDIVIDUALLY, SO A REPLACEMENT WAS USED. THE INCIDENT OCCURRED DURING USE. PER FOLLOW UP INFORMATION RECEIVED VIA TASK ON 12FEB2026, COMPLAINT PRODUCT NOT RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24206416 ↗
• MalfunctionJan 28, 2026Material Separation

  IT WAS REPORTED THAT THE RCC RECEIVED A COMPLAINT VIA EMAIL. THEY WERE WRITING TO REPORT AN ISSUE WITH A DEFECTIVE ARCTIC GEL PAD. IT APPEARS THE DEFECT WAS WITH THE RIGHT CHEST PAD. DETAILS REGARDING THE INCIDENT ON (B)(6) 2026, A NEW SMALL ARCTIC SUN PACKAGE WAS OPENED FOR USE ON A ROSC PATIENT. UPON REMOVING THE FILM FROM THE ADHESIVE SIDE, THE ADHESIVE REMAINED ON THE PROTECTIVE FILM. THIS CAUSED AN INADEQUATE SEAL ON THE PATIENT, RESULTING IN TEMPERATURE FLUCTUATIONS DURING TTM. GIVEN THIS DEFECT, THEY WERE ASKING WHETHER THEY CAN BE ABLE TO RECEIVE A REPLACEMENT PAD SET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24205992 ↗
• MalfunctionNov 4, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT THIS WAS A MEMO TO INFORM, THAT THEY HAVE RECEIVED A COMPLAINT REGARDING, ARCTIC GEL PAD WHOSE ADHESIVE PART HAS COME OFF DESPITE REMOVING THE PROTECTIVE FILM IN THE RIGHT PLACE. PRODUCT NUMBER: 31705, COOLING SET FOR MAINTAINING BODY TEMPERATURE SMALL ARCTIC, LOT NUMBER: NGJX2089. SUBOPTIMAL THERAPY DUE TO PRODUCT FAILURE. FURTHERMORE, THE EQUIPMENT IN PLACE WAS EXPENSIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23471906 ↗
• MalfunctionOct 26, 2025Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT THEY WERE GETTING A LOW FLOW ALARM ON ARCTIC SUN DEVICE S/N (B)(6). THEY FILLED THE RESERVOIR, BUT THAT DID NOT RESOLVE THE ISSUE. FLOW RATE (FR) WAS 0LPM, INLET PRESSURE (IP) WAS -0PSI, CIRCULATION PUMP COMMAND (CPC) WAS 0%. PUMP HOURS WERE 388, SYSTEM HOURS WERE 578. SMALL PADS IN USE. STOPPED THERAPY. DISCONNECTED AND RECONNECTED THE PADS USING PROPER TECHNIQUE. FLOW RATE WAS 1PM, INLET PRESSURE (IP) WAS -0.7PSI, CIRCULATION PUMP COMMAND (CPC) WAS 100%. STOPPED THERAPY. DISCONNECTED PADS. STARTED DEVICE IN MANUAL MODE. FLOW RATE WAS 1.8LPM, INLET PRESSURE (IP) WAS -7.1PSI, CIRCULATION PUMP COMMAND (CPC) WAS 48%. CONNECTED PADS (LOT NGJV0901) ONE AT A TIME. LEFT THIGH INLET PRESSURE (IP) WAS -0.7PSI. DISCONNECTED LEFT THIGH. CONNECTED LEFT CHEST FLOW RATE WAS 0.9LPM, INLET PRESSURE (IP) WAS -7PSI, CIRCULATION PUMP COMMAND (CPC) WAS 31%. RIGHT CHEST FLOE RATE WAS 2.1LPM, INLET PRESSURE WAS-7.2PSI, CIRCULATION PUMP COMMAND (CPC) WAS 51%. RIGHT THIGH FLOW RATE 2.8LPM, INLET PRESSURE WAS-7.2PSI, CIRCULATION PUMP COMMAND (CPC) WAS 65%. PLACED DEVICE BACK IN AUTOMATIC MODE. SUGGESTED REPLACING THE LEFT THIGH WITH A UNIVERSAL PAD. ASKED TO PLACE LEFT THIGH PAD BEHIN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23387948 ↗
• MalfunctionOct 24, 2025Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT LOW FLOW ALARM OCCURRED IMMEDIATELY AFTER USED THE ARCTIC SUN DEVICE AND NO FLOW. PER REVIEW OF WO ON (B)(6) 2025, DEVICE WAS USED ON PATIENT AND THERE WAS NO PATIENT INJURY REPORT. PER FOLLOW UP INFORMATION RECEIVED VIA MAIL ON 17OCT2025, DEVICE WAS NOT SENT FOR EVALUATION BECAUSE IT WAS FOUND THAT GEL PAD FAILURE WAS CAUSED OF ISSUE. ISSUE WAS GEL PAD MALFUNCTION. PATIENT THERAPY COMPLETION STATUS WAS UNDER INVESTIGATION. PER ADDITIONAL INFORMATION RECEIVED VIA MAIL ON 24OCT2025, ACCORDING TO IMI, GEL PAD'S LOT WAS NGJZ2081. AND ITS SIZE WAS (S).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23378493 ↗
• MalfunctionOct 23, 2025Loss of or Failure to Bond; Restricted Flow rate; Loss of or Failure to Bond; Restricted Flow rate

  IT WAS REPORTED THAT A LOW FLOW ALARM OCCURRED IMMEDIATELY AFTER STARTING USE OF THE ARCTIC GEL PADS, AND NO FLOW WAS OBSERVED. PER FOLLOW UP INFORMATION RECEIVED VIA TASK ON 23OCT2025, NUMBER OF PRODUCTS AFFECTED WAS 1. NO PATIENT HARM OR INJURY. SAMPLE WOULD BE RETURNED AND LET KNOW THE TRACKING ID IN NEAR FUTURE. PHOTO SAMPLE WAS NOT PROVIDED AND ATTACHED LATER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23369519 ↗
• MalfunctionOct 15, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE CONNECTION PART OF THE ARCTIC GEL PAD WAS CRUSHED AND DEFORMED, SO IT COULD NOT BE CONNECTED TO THE CIRCULATION HOSE. THE CUSTOMER WISHES TO RETURN IT FOR AN EXCHANGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23301295 ↗
• MalfunctionOct 2, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT DURING PATIENT USE, THE ARCTIC SUN DEVICE HAD ERROR 113 (REDUCED WATER TEMPERATURE CONTROL) SOUNDED, AND THE FLOW RATE WAS LOW AT 2.2 L/MIN. HEALTH PROFESSIONAL CHECKED THE CONNECTOR SECTION OF THE GEL PAD AND FOUND BUBBLES (AIR) HAD ENTERED. TO DETERMINE WHETHER THE CAUSE WAS ON THE MAIN UNIT SIDE OR THE PAD SIDE, IT WAS CONNECTED TO THE VERIFICATION LINE, CONFIRMING IT WAS THE PAD SIDE. AFTER REINSTALLING THE PAD CONNECTOR ONTO THE ARCTIC SUN UNIT, THE AIR DISAPPEARED, AND THE FLOW RATE INCREASED TO 3 L/MIN. TREATMENT CONTINUED AS IS TO MONITOR THE SITUATION. SUBSEQUENTLY, A SIMILAR ISSUE RECURRED APPROXIMATELY THREE HOURS LATER. BODY TEMPERATURE CONTROL WAS MAINTAINED, SO PATIENT TREATMENT CONTINUED. AFTER TREATMENT COMPLETION, THE RESPONSIBLE STAFF MEMBER VISITED WHILE THE HEALTH PROFESSIONAL WAS PERFORMING A RUNNING CHECK. TO INVESTIGATE THE PAD DEFECT, THE PAD HOSE WAS STRIPPED, REVEALING MULTIPLE LOCATIONS WHERE THE TUBE WAS CRUSHED. FURTHER CRUSHING OF THE TUBE DURING OPERATION WAS OBSERVED. THE STORAGE BOX SHOWED NO ABNORMALITIES. IT WAS UNLIKELY THE TUBE WAS CRUSHED BY CONTACT WITH THE PATIENT, BED, OR OTHER PERIPHERAL EQUIPMENT DURING TREATMENT, RAIS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23200523 ↗
• MalfunctionSep 17, 2025Inaccurate Flow Rate; Inaccurate Flow Rate

  A SLOW FLOW RATE ISSUE OCCURED WHEN OPERATING THE EQUIPMENT FOR TTM. PER FOLLOW UP INFORMATION RECEIVED VIA TASK ON 18SEP2025, THE NUMBER OF QUANTITIES AFFECTED WAS 1 AND ATTACHED A PHOTO OF THE ARCTIC GEL PAD SAMPLE WITH THE PAD INFORMATION FOR (B)(4). PER SAMPLE EVALUATION RESULTS RECEIVED VIA TASK ON 15JAN2026, IT WAS REPORTED THAT THE IN THE PHOTO RETURNED BY THE CUSTOMER, THE HYDROGEL LAYER APPEARS TO BE ABSENT FROM THE PAD SURFACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23071058 ↗
• MalfunctionAug 29, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE ARCTIC GEL PAD CANNOT BE USED DUE TO POOR ADHESION. PER FOLLOW UP INFORMATION RECEIVED VIA MAIL ON 30MAY2025, IT WAS NOTED THAT THE EVENT OCCURRENCE AS ONE, EVENT OCCURRENCE DATE WAS MAY 29TH, 2025. REP WILL SEND THE PRODUCT TO THE BD-APPROVED FACILITY, ISSUE RESOLVED BY REPLACED WITH A NEW PRODUCT. COULDN'T RESOLVE IT SO, ICU STAFF EXCHANGED IT FOR A NEW ONE. NO PATIENT INVOLVEMENT. SAMPLE TRACKING INFORMATION THEY WILL SEND IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22926147 ↗
• MalfunctionAug 29, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT THEY HAD AN ISSUE WITH ARCTIC GEL PAD. END USER WAS REPORTING THAT THE ADHESIVE WAS COMING OFF WHEN REMOVING THE CELLOPHANE WRAPPING, THEY HAVE QUARANTINED THE PRODUCT AND 2 OTHERS WITH THE SAME LOT NUMBER (NGJW1496) AND WOULD APPRECIATE IF THEY COULD ARRANGE COLLECTION FOR INVESTIGATION AND REPLACEMENT OF THESE. PER FOLLOW UP INFORMATION RECEIVED VIA MAIL ON 22APR2025, THE FAULTY PRODUCT WAS NOTED ON THE (B)(6). THE PROCUREMENT DEPARTMENT HAS THE PRODUCT, IF THEY WOULD LIAISE WITH THEM TO COLLECT. THE SAMPLE WAS NEVER ATTACHED TO THE PATIENT, SO NO RISKS ATTACHED. THE PATIENT WAS UNHARMED, THANKFULLY THEY HAD ANOTHER SET OF PADS TO USE. PER FOLLOW UP INFORMATION RECEIVED VIA TASK ON 15MAY2025, THEY HAVE THE ACTUAL ITEM AND ONE UNOPENED ITEM FROM THE SAME BATCH THERE AT CENTRAL STORES IN (B)(6) AS CONFIRMED IN E-MAIL. THE ISSUE WAS IDENTIFIED DURING PREPARATION. PER SAMPLE EVALUATION RESULTS ON 01AUG2025, PADS FROM TWO LOTS WERE RECEIVED FOR THIS COMPLAINT. THE SAMPLE BAGS CONTAINED THREE OPENED PADS FROM LOT NGJW1496, ONE UNOPENED SET FROM LOT NGJW1496, AND ONE OPENED CHEST PAD WITH A LOT NGJS1987 STICKER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22923927 ↗
• MalfunctionAug 29, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT THEY HAD AN ISSUE WITH ARCTIC GEL PAD. END USER WAS REPORTING THAT THE ADHESIVE WAS COMING OFF WHEN REMOVING THE CELLOPHANE WRAPPING, THEY HAVE QUARANTINED THE PRODUCT AND 2 OTHERS WITH THE SAME LOT NUMBER (NGJW1496) AND WOULD APPRECIATE IF THEY COULD ARRANGE COLLECTION FOR INVESTIGATION AND REPLACEMENT OF THESE. PER FOLLOW UP INFORMATION RECEIVED VIA MAIL ON 22APR2025, THE FAULTY PRODUCT WAS NOTED ON THE 15TH APRIL. THE PROCUREMENT DEPARTMENT HAS THE PRODUCT, IF THEY WOULD LIAISE WITH THEM TO COLLECT. THE SAMPLE WAS NEVER ATTACHED TO THE PATIENT, SO NO RISKS ATTACHED. THE PATIENT WAS UNHARMED, THANKFULLY THEY HAD ANOTHER SET OF PADS TO USE. PER FOLLOW UP INFORMATION RECEIVED VIA TASK ON 15MAY2025, THEY HAVE THE ACTUAL ITEM AND ONE UNOPENED ITEM FROM THE SAME BATCH THERE AT CENTRAL STORES IN HAIRMYRES HOSPITAL AS CONFIRMED IN E-MAIL. THE ISSUE WAS IDENTIFIED DURING PREPARATION. PER SAMPLE EVALUATION RESULTS ON 01AUG2025, PADS FROM TWO LOTS WERE RECEIVED FOR THIS COMPLAINT. THE SAMPLE BAGS CONTAINED THREE OPENED PADS FROM LOT NGJW1496, ONE UNOPENED SET FROM LOT NGJW1496, AND ONE OPENED CHEST PAD WITH A LOT NGJS1987 STICKER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22923915 ↗
• MalfunctionAug 25, 2025Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE PATIENT ON THERAPY. STOPPED TO GO TO CT. RETURNED AND THEY HAVE BEEN GETTING CONSISTENT 02 LOW FLOW & PATIENT TEMPERATURE (PT) WAS LINE OPEN ALERTS IN AN ARCTIC SUN DEVICE. ADULT PATIENT. 4 SIZE SMALL PADS CONNECTED. PATIENT TEMPERATURE (PT) WAS 37.4C, TARGETED TEMPERATURE (TT) WAS 37C, WATER FLOW RATE (WFR) WAS 0.3 L/M. HAD THEM STOP THERAPY, DISCONNECT PADS AND PLACE THE DEVICE IN MANUAL CONTROL AT 10C WITH NO PADS. SYSTEM DIAGNOSTICS, OUTLET MONITOR TEMPERATURE (T1) WAS 12.8C, OUTLET CONTROL TEMPERATURE (T2) WAS 12.7C, INLET TEMPERATURE (T3) WAS 12.1C, CHILLER TEMPERATURE (T4) WAS 8.8C, WATER FLOW RATE (WFR) WAS 1.9 L/M, INLET PRESSURE (IP) WAS -6.9PSI, CIRCULATION PUMP COMMAND (CPC) WAS 55%, MIXING PUMP COMMAND (MPC) WAS 100%, HEATER COMMAND (HC) WAS 0, WATER RESERVOIR LEVEL (WRL) WAS 5, SYSTEM HOURS WERE 5502.6, PUMP HOURS WERE 1646.9. ADDED PADS TO DEVICE WHILE STILL IN MANUAL CONTROL WATER FLOW RATE (WFR) WAS 1.6 L/M, INLET PRESSURE (IP) WAS -1.4PSI. HAD THEM STOP THERAPY AND DISABLED MANUAL CONTROL. RESTARTED THERAPY AND WATER FLOW RATE (WFR) WAS PRIMED TO 0 L/M. ADVISED TO SWAP OUT THE PADS. THEY COULD HAVE BEEN DAMAGED IN TRANSPORT OR DURING CT. S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22890734 ↗
• MalfunctionAug 21, 2025Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE TSS CALLED HELPLINE AFTER HOURS ANSWERING SERVICE. NEEDS ASSISTANCE WITH LOW FLOW IN AN ARCTIC SUN DEVICE USED FOR TRAINING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22862786 ↗
• MalfunctionAug 14, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE WATER LEAKED FROM THE ARCTIC GEL PAD WHILE THE PATIENT WAS USING IT. PER SAMPLE EVALUATION RESULTS RECEIVED VIA (B)(4) ON (B)(6) 2026, IT WAS REPORTED THAT THE FLOW RATE WAS UNOBTAINABLE DUE TO AIR LEAK. WATER LEAK COULD NOT BE REPRODUCED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22806001 ↗
• MalfunctionAug 11, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT THE GEL HAD COME OFF THE ARCTIC GEL PAD. THE INCIDENT OCCURRED BEFORE USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22770040 ↗
• MalfunctionJul 31, 2025Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT THE CONNECTION PORT ON THE UPPER LEFT BODY OF ARCTIC GEL PAD WAS DEFORMED AND COULD NOT BE CONNECTED, SO ANOTHER SET WAS OPENED AND USED. PER FOLLOW UP INFORMATION RECEIVED VIA TASK ON 05AUG2025, SAMPLE WILL BE RETURNED, AND THEY LET KNOW THE TRACKING ID IN NEAR FUTURE. NO IMPACT TO THE PATIENT DUE TO THE USE OF THE PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22675979 ↗
• MalfunctionJul 30, 2025Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT THE NURSE STATED THAT THEY WERE TRYING TO INITIATE THERAPY, BUT THE ARCTIC SUN DEVICE WAS ALERTING FLUID DELIVERY LINE (FDL) AND LOW FLOW. WALKED THROUGH STOP THERAPY, EMPTY AND DISCONNECT PADS. VERIFIED FLUID DELIVERY LINE (FDL) SECURE AND LOCKED. RECONNECTED PADS AND STRAIGHTENED LINES. RESTARTED THERAPY WATER FLOW RATE (WFR) STABILIZED AT 0 L/M AND DEVICE ALERTED FLUID DELIVERY LINE (FDL) OPEN. WALKED THROUGH DISCONNECT PADS. PLACED IN MANUAL CONTROL AT 35C. SYSTEM DIAGNOSTICS SHOWED THAT THE OUTLET MONITOR TEMPERATURE (T1) WAS 6.7C, OUTLET CONTROL TEMPERATURE (T2) WAS 7.2C, INLET TEMPERATURE (T3) WAS 7.1C, CHILLER TEMPERATURE (T4) WAS 5.7C, WATER FLOW RATE (WFR) WAS 1.9 L/M, INLET PRESSURE (IP) WAS -8.9PSI, CIRCULATION PUMP COMMAND (CPC) WAS 55 PERCENTAGE, MIXING PUMP COMMAND (MPC) WAS 0, HEATER WAS 100, WATER RESERVOIR LEVEL (WRL) WAS 5, SYSTEM HOURS WERE 6741.3 AND PUMP HOURS WERE 819.8. ADDED PADS BACK WHILE STILL IN MANUAL CONTROL WATER FLOW RATE (WFR) WAS 0.3 L/M IP -2 PSI. ADVISED SWAP OUT DEVICE AND SEND TO BIOMED LABELED LOW FLOW AND FDL OPEN. ENCOURAGED NURSE TO CALL BACK IF ADDITIONAL ASSISTANCE IS NEEDED WITH THE NEW DEVICE. MSICU NURSE SPOKE TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22667090 ↗