Arctic Sun® Temperature Management System, ArcticGel™ Pads 31707Recalls & reported problems

Summary

The FDA's MAUDE database contains 90 adverse event reports that list this exact device (DI 00801741080081), received between Oct 23, 2020 and Jul 27, 2026 — classified as 1 injury, 89 malfunctions.

The most frequently reported specific device problem is “Inaccurate Flow Rate” (21 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.

• MalfunctionJul 27, 2026Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50022353 ↗
• MalfunctionApr 20, 2026Material Separation

  IT WAS REPORTED THAT THE GEL AND PATCH PEELING IN AN ARCTIC GEL PAD. CHANGE TO ANOTHER SET. THE INCIDENT OCCURRED DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24933485 ↗
• MalfunctionApr 7, 2026Inaccurate Flow Rate

  IT WAS REPORTED THAT THE NURSE WAS TRYING TO START THERAPY, BUT DEVICE PRIMED AND STOPPED. DISCONNECTED AND RECONNECTED PADS USING PROPER TECHNIQUE AND RESTARTED THERAPY IN AN ARCTIC SUN DEVICE. GUIDED TO DIAGNOSTICS SHOWED THAT THE SYSTEM HOURS WERE 945, PUMP HOURS WERE 853, INLET PRESSURE (IP) WAS -1.3PSI, CIRCULATION PUMP COMMAND (CPC) WAS 100 PERCENTAGE, FLOW RATE (FR) WAS 0LPM, PRIMED THEN STOPPED. STOPPED THERAPY, DRAINED AND DISCONNECTED PADS AND PLACED DEVICE IN MANUAL CONTROL, NO PADS ATTACHED INLET PRESSURE (IP) WAS -6.9PSI, CIRCULATION PUMP COMMAND (CPC) WAS 47 PERCENTAGE, FLOW RATE (FR) WAS 1.7LPM. SOMEONE CAME IN WITH A NEW DEVICE AT THIS TIME (B)(6). TRIED TO START THERAPY ONE MORE TIME ON THE FIRST DEVICE, BUT IT PRIMED AND STOPPED AGAIN. MOVED PADS AND PROBE TO NEW DEVICE. DEVICE DID NOT STOP, BUT FLOW RATE (FR) WAS ONLY 0.2LPM. GUIDED TO DIAGNOSTICS SHOWED THAT THE SYSTEM HOURS WERE 1109, PUMP HOURS WERE 1091, INLET PRESSURE (IP) WAS -1.5PSI, CIRCULATION PUMP COMMAND (CPC) WAS 100 PERCENTAGE, FLOW RATE (FR) WAS 0.2LPM. THEY WOULD CHANGE PADS AT THIS TIME AND CALL BACK IF THEY CONTINUE TO HAVE ISSUES. PAD LOT NGKX3637. ADVISED THEY SHOULD HOLD ONTO THESE PADS FOR IN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24801210 ↗
• MalfunctionMar 21, 2026Inaccurate Flow Rate; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT DURING TTM TREATMENT IN AN ARCTIC SUN DEVICE, A LOW-FLOW ALARM WAS ACTIVATED, AND WATER LEAKAGE WAS OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24657045 ↗
• MalfunctionMar 21, 2026Inaccurate Flow Rate; Component Misassembled

  IT WAS REPORTED THAT POOR FLOW RATE WAS PREVENTING WATER CIRCULATION IN THE ARCTIC GEL PAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24656962 ↗
• MalfunctionFeb 26, 2026Inaccurate Flow Rate

  IT WAS REPORTED THAT THEY COULD NOT GET A FLOW RATE WITH THE ARCTIC GEL PADS. TRIED SWITCHING DEVICE AND STILL COULD NOT GET FLOW. PER ADDITIONAL INFORMATION UPDATED FROM TTM ON 19FEB2026, THEY WERE UNABLE TO GET A FLOW RATE. THEY HAVE ALREADY CHANGED THE ARCTIC SUN DEVICE, MADE SURE THERE WERE NO KINKS, AND THE CONFIRMED THE RESERVOIR WAS FULL. THEY WERE CURRENTLY TRYING S/N (B)(6). FLOW RATE (FR) WAS 0LPM, INLET PRESSURE (IP) WAS -0.1PSI, CIRCULATION PUMP COMMAND (CPC) WAS 100%. SYSTEM HOURS 3969. PUMP HOURS 455. STOPPED THERAPY. EMPTIED AND DISCONNECTED PADS. STARTED MANUAL MODE, FLOW RATE (FR) WAS 1.7LPM, INLET PRESSURE (IP) WAS -7.1PSI, CIRCULATION PUMP COMMAND (CPC) WAS 54%. CONNECTED PADS ONE AT A TIME. LOT FOR FULL SET OF MEDIUM PADS WAS NGKW1608. UNIVERSAL PAD NGKU1400. CONNECTED UNIVERSAL PAD. FLOW RATE (FR) WAS 0.5LPM, INLET PRESSURE (IP) WAS -7.2PSI, CIRCULATION PUMP COMMAND (CPC) WAS 29%. CONNECTED LEFT CHEST PAD. FLOW RATE (FR) WAS 1.2LPM, INLET PRESSURE (IP) WAS -7.3PSI, CIRCULATION PUMP COMMAND (CPC) WAS 39%. CONNECTED LEFT THIGH PAD. FLOW RATE (FR) WAS 0LPM, INLET PRESSURE (IP) WAS -0.3PSI, CIRCULATION PUMP COMMAND (CPC) WAS 100%. REMOVED LEFT THIGH PAD. CONNECTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24464311 ↗
• MalfunctionFeb 26, 2026Restricted Flow rate

  IT WAS REPORTED THAT THEY COULD NOT GET A FLOW RATE WITH THE ARCTIC GEL PADS. TRIED SWITCHING DEVICE AND STILL COULD NOT GET FLOW. PER ADDITIONAL INFORMATION UPDATED FROM TTM ON 19FEB 2026, THEY WERE UNABLE TO GET A FLOW RATE. THEY HAVE ALREADY CHANGED THE ARCTIC SUN DEVICE, MADE SURE THERE WERE NO KINKS, AND THE CONFIRMED THE RESERVOIR WAS FULL. THEY WERE CURRENTLY TRYING S/N (B)(6). FLOW RATE (FR) WAS 0LPM, INLET PRESSURE (IP) WAS -0.1PSI, CIRCULATION PUMP COMMAND (CPC) WAS 100%. SYSTEM HOURS 3969. PUMP HOURS 455. STOPPED THERAPY. EMPTIED AND DISCONNECTED PADS. STARTED MANUAL MODE, FLOW RATE (FR) WAS 1.7LPM, INLET PRESSURE (IP) WAS -7.1PSI, CIRCULATION PUMP COMMAND (CPC) WAS 54%. CONNECTED PADS ONE AT A TIME. LOT FOR FULL SET OF MEDIUM PADS WAS (B)(6). UNIVERSAL PAD (B)(6). CONNECTED UNIVERSAL PAD. FLOW RATE (FR) WAS 0.5LPM, INLET PRESSURE (IP) WAS -7.2PSI, CIRCULATION PUMP COMMAND (CPC) WAS 29%. CONNECTED LEFT CHEST PAD. FLOW RATE (FR) WAS 1.2LPM, INLET PRESSURE (IP) WAS -7.3PSI, CIRCULATION PUMP COMMAND (CPC) WAS 39%. CONNECTED LEFT THIGH PAD. FLOW RATE (FR) WAS 0LPM, INLET PRESSURE (IP) WAS -0.3PSI, CIRCULATION PUMP COMMAND (CPC) WAS 100%. REMOVED LEFT THIGH PAD. CONNECTED RIG

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24464309 ↗
• MalfunctionFeb 18, 2026Restricted Flow rate

  IT WAS REPORTED THAT THE NURSE NOTED THAT THEY WERE GETTING NO FLOW IN AN ARCTIC SUN DEVICE. THEY CHANGED THE PADS BECAUSE IT APPEARED THE HYDROGEL WAS COMING OFF OF THEM. STARTING THERAPY WITH NEW PADS, FLOW RATE (FR) WAS 3.2 LPM. THEY HAD DISPOSED OF THE PADS BUT PULLED ONE PAD AND THE PACKAGING FROM THE BIN. LOT NUMBER NGKQ3434. FLOW RATE (FR) WAS 3.2 LPM. GUIDED TO DIAGNOSTICS SHOWED THAT THE SYSTEM HOURS WERE 3776, PUMP HOURS WERE 3425, INLET PRESSURE (IP) WAS -7.3PSI, CIRCULATION PUMP COMMAND (CPC) WAS 87 PERCENTAGE. ADVISED SHOULD HOLD ONTO PADS FOR RETURN. EMAILED CASE TO PRODUCT COMPLAINTS. PER FOLLOW UP INFORMATION RECEIVED VIA TASK ON 05FEB2026, SPOKE WITH NURSE WHO CONFIRMED THE PAD WAS TIED UP IN A PLASTIC BAG BEHIND THE TRIAGE DESK. THEY WOULD MOVE IT TO THE SUPPLIES OFFICE SO IT WOULD NOT BE THROWN AWAY. CONFIRMED MAIN ADDRESS WITH ATTENTION TO THE ICU AND WAS UNABLE TO CONFIRM THE SIZE OF THE PAD THROUGH THE BAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24381323 ↗
• MalfunctionFeb 9, 2026Restricted Flow rate

  IT WAS REPORTED THAT THE NURSE HAS BEEN TRYING TO START THERAPY FOR SOME TIME. THEY TRIED TWO ARCTIC SUN DEVICES AND TWO BRAND NEW SETS OF PADS ALREADY. HAD DISCONNECT AND RECONNECT USING PROPER TECHNIQUE. RESTARTED THERAPY AND FLOW RATE (FR) WENT TO 0LPM. GUIDED TO DIAGNOSTICS SHOWED THAT THE SYSTEM HOURS WERE 2256, PUMP HOURS WERE 2070, INLET PRESSURE (IP) WAS -0.6PSI, CIRCULATION PUMP COMMAND (CPC) WAS 100 PERCENTAGE, FLOW RATE (FR) WAS 0LPM. TRIED SECOND DEVICE (DYCWY527). SYSTEM HOURS WERE 162, PUMP HOURS WERE 95, INLET PRESSURE (IP) WAS -4.2PSI, CIRCULATION PUMP COMMAND (CPC) WAS 100 PERCENTAGE, FLOW RATE (FR) WAS 1.2LPM (MEDIUM SIZE PADS). STOPPED THERAPY, DRAINED PADS AND PLACED DEVICE IN MANUAL CONTROL. NO PADS ATTACHED, INLET PRESSURE (IP) WAS -7PSI, CIRCULATION PUMP COMMAND (CPC) WAS 65 PERCENTAGE, FLOW RATE (FR) WAS 1.9LPM. THE NEXT PAD GOT ANOTHER PAGE. SINCE THIS WAS A TIME-CONSUMING PROCESS AND DID NOT WISH TO LEAVE THE OTHER CUSTOMERS WAITING, THEY INSTRUCTED ON HOW TO WATCH FOR STABLE INLET PRESSURE (IP) WAS AT -7PSI AND ADDED THE PADS ONE AT A TIME. AFTER SPEAKING TO THE OTHER CUSTOMER, THEY CALLED BACK, THEN ADDED THE RIGHT CHEST AND THIGH AND BOTH STABILIZED AT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24292027 ↗
• MalfunctionFeb 9, 2026Inaccurate Flow Rate

  IT WAS REPORTED THAT THE NURSE HAS BEEN TRYING TO START THERAPY FOR SOME TIME. THEY TRIED TWO ARCTIC SUN DEVICES AND TWO BRAND NEW SETS OF PADS ALREADY. HAD DISCONNECT AND RECONNECT USING PROPER TECHNIQUE. RESTARTED THERAPY AND FLOW RATE (FR) WENT TO 0LPM. GUIDED TO DIAGNOSTICS SHOWED THAT THE SYSTEM HOURS WERE 2256, PUMP HOURS WERE 2070, INLET PRESSURE (IP) WAS -0.6PSI, CIRCULATION PUMP COMMAND (CPC) WAS 100 PERCENTAGE, FLOW RATE (FR) WAS 0LPM. TRIED SECOND DEVICE ((B)(6)). SYSTEM HOURS WERE 162, PUMP HOURS WERE 95, INLET PRESSURE (IP) WAS -4.2PSI, CIRCULATION PUMP COMMAND (CPC) WAS 100 PERCENTAGE, FLOW RATE (FR) WAS 1.2LPM (MEDIUM SIZE PADS). STOPPED THERAPY, DRAINED PADS AND PLACED DEVICE IN MANUAL CONTROL. NO PADS ATTACHED, INLET PRESSURE (IP) WAS -7PSI, CIRCULATION PUMP COMMAND (CPC) WAS 65 PERCENTAGE, FLOW RATE (FR) WAS 1.9LPM. THE NEXT PAD GOT ANOTHER PAGE. SINCE THIS WAS A TIME-CONSUMING PROCESS AND DID NOT WISH TO LEAVE THE OTHER CUSTOMERS WAITING, THEY INSTRUCTED ON HOW TO WATCH FOR STABLE INLET PRESSURE (IP) WAS AT -7PSI AND ADDED THE PADS ONE AT A TIME. AFTER SPEAKING TO THE OTHER CUSTOMER, THEY CALLED BACK, THEN ADDED THE RIGHT CHEST AND THIGH AND BOTH STABILIZED AT -7

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24292017 ↗
• MalfunctionFeb 4, 2026Inaccurate Flow Rate; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT AT THE ARCTIC GEL PAD WAS APPLIED TO PATIENT, BUT CONTINUOUS LOW FLOW RATE WAS OBSERVED. AFTER REPLACING WITH NEW GEL PAD, THE FLOW RATE RETURNED TO NORMAL. THE INITIAL PAD WAS DETERMINED TO BE DEFECTIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24264502 ↗
• MalfunctionFeb 3, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE ARCTIC GEL PAD LEAKAGE. THE INCIDENT OCCURRED DURING USE. PER FOLLOW UP INFORMATION RECEIVED VIA MAIL ON 28JAN2026, THE NUMBER OF PRODUCTS AFFECTED WAS 1. NO IMPACT TO THE PATIENT, PATIENT WAS SAFE. GET THE PICTURE FROM HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24254716 ↗
• MalfunctionDec 17, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE ARCTIC SUN DEVICE ALERTING LOW AIR LEAK. SIZE MEDIUM PADS. NORMOTHERMIA PATIENT TEMPERATURE (PT) WAS 35.6C, TARGETED TEMPERATURE (TT) WAS 37C, WATER TEMPERATURE (WT) WAS 0 L/M. NURSE STATED DEVICE JUST KEEPS PRIMING TO 0 L/M AND ALERTING AIR LEAK. THEY'VE ALREADY TRIED DISCONNECTING AND RECONNECTING WITH NO RESOLUTION. WALKED THROUGH STOP THERAPY, EMPTY PADS AND DISCONNECT. PLACED DEVICE IN MANUAL CONTROL AT 36C WITH NO PADS. SYSTEM DIAGNOSTICS: OUTLET MONITOR TEMPERATURE (T1) WAS 17.3C, OUTLET CONTROL TEMPERATURE (T2) WAS 17C, INLET TEMPERATURE (T3) WAS 17.6C, CHILLER TEMPERATURE (T4) WAS 5.5C, WATER FLOW RATE (WFR) WAS 1.7 L/M, INLET PRESSURE (IP) WAS -7 PSI, CIRCULATION PUMP COMMAND (CPC) WAS 52%, MIXING PUMP COMMAND (MPC) WAS 0, HEATER 100%, WATER RESERVOIR LEVEL (WRL) WAS 5, SYSTEM HOURS 1539.8, PUMP HOURS 1311.2. RECONNECTED PADS AND DEVICE SHUT OFF. CONFIRMED DEVICE WAS PLUGGED INTO BED. HAD THEM PLUG IN GROUNDED WALL OUTLET. WATER FLOW RATE (WFR) WAS 1.1 L/M IN MANUAL CONTROL WITH INLET PRESSURE (IP) WAS -1 PSI. WALKED THROUGH DISABLING MANUAL CONTROL. RESTARTED THERAPY AND WATER FLOW RATE (WFR) PRIMED TO 0 L/M WITH LOW AIR LEAK ALERT. ADVISED TO SW

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23832101 ↗
• MalfunctionNov 26, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE ARCTIC GEL PAD WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23660256 ↗
• MalfunctionOct 17, 2025Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT IN NEW THERAPY, ARCTIC SUN DEVICE PRIMED AND STOPPED. FLOW RATE (FR) WAS 0LPM. GUIDED TO DIAGNOSTICS, SYSTEM HOURS 1719, PUMP HOURS 1422, INLET PRESSURE (IP) WAS -0.7PSI, CIRCULATION PUMP COMMAND (CPC) WAS 100%, FLOW RATE (FR) WAS 0LPM. ADJUSTED TUBING, DISCONNECTED AND RECONNECTED USING PROPER TECHNIQUE. DEVICE PRIMED AND STOPPED. NO OTHER DEVICES AVAILABLE PER NURSE. STOPPED THERAPY, DRAINED/DISCONNECTED PADS AND PLACED DEVICE IN MANUAL CONTROL, INLET PRESSURE (IP) WAS -7PSI, CIRCULATION PUMP COMMAND (CPC) WAS 55%, INLET PRESSURE (IP) WAS 1.6LPM. ADDED PADS BACK ONE AT A TIME AND INLET PRESSURE (IP) WOULD NEVER GET ABOVE -1.1LPM, CIRCULATION PUMP COMMAND (CPC) WAS 100% ALL PADS, INLET PRESSURE (IP) WOULD NOT GET ABOVE .08LPM. THEY WERE CHANGING THE FULL SET OF PADS RATHER THAN DO MORE TROUBLESHOOTING. DISABLED MANUAL CONTROL. CONTACT DAY CHARGE NURSE FOR PAD RETURN (NGKQ3434).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23328838 ↗
• MalfunctionSep 15, 2025Fluid/Blood Leak; Gel Leak; Fluid/Blood Leak; Gel Leak

  IT WAS REPORTED THAT THE ARCTIC GEL PAD LEAKAGE CAUSED ABNORMAL DEVICE OPERATION, WHICH WAS RESOLVED BY REPLACING IT WITH A NEW GEL PAD. THE ISSUE WAS NOTICED AT THE MOMENT OF USE. THE AFFECTED PRODUCT WAS USED ON A PATIENT. NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23053512 ↗
• MalfunctionSep 9, 2025Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT WHILE ATTEMPTING TO PLACE PATIENT ON ARCTIC SUN COOLING SYSTEM. STAFF WENT THROUGH 3 SETS OF MEDIUM PADS, BUT PADS WERE FAULTY. FIRST FAILURE WAS PUMP MACHINE INDICATING FLOW ERROR, SPECIFICALLY NO WATER WAS FLOWING THROUGH PADS. SECOND FAILURE WAS PADS HAD FAULTY/MISSING GLUE/STICKY LAYER FOR ATTACHING TO SKIN. THIRD FAILURE WAS SET ALSO HAD FLOW ERROR MESSAGE ON MACHINE. NO INJURY WAS FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23008516 ↗
• MalfunctionSep 9, 2025Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE WHILE ATTEMPTING TO PLACE PATIENT ON ARCTIC SUN COOLING SYSTEM. STAFF WENT THROUGH 3 SETS OF MEDIUM PADS, BUT PADS WERE FAULTY. FIRST FAILURE WAS PUMP MACHINE INDICATING FLOW ERROR, SPECIFICALLY NO WATER WAS FLOWING THROUGH PADS. SECOND FAILURE WAS PADS HAD FAULTY/MISSING GLUE/STICKY LAYER FOR ATTACHING TO SKIN. THIRD FAILURE WAS SET ALSO HAD FLOW ERROR MESSAGE ON MACHINE. NO INJURY WAS FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23005293 ↗
• MalfunctionAug 29, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT THE RN OPENED BRAND NEW ARCTIC SUN PAD AND THE ADHESIVE COVER WAS NOT ON THE PAD CORRECTLY. THE STICKY MATERIAL WAS DEFECTIVE. PER FOLLOW UP INFORMATION RECEIVED VIA MAIL ON 10JUN2025, THEY RECEIVED ONE KIT WHICH THEY SENT BACK WITH SAMPLE. RECENTLY THEY RECEIVED ANOTHER DEFECTED PAD AND IN NEED FOR ANOTHER KIT TO MAIL IT BACK. SAMPLE WILL BE RETURNING.

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

  MAUDE report 22926152 ↗
• MalfunctionAug 19, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT ON (B)(6), THEY RECEIVED NEGATIVE FEEDBACK FROM THEIR CUSTOMERS REGARDING THE QUALITY OF THE ARCTIC GEL PADS. THEY REPORTED THAT WHEN THEY OPENED A NEW PACK, THE GEL PAD WAS IN VERY POOR CONDITION FLABBY, WITH THE HYDROGEL LAYER NEARLY PEELING OFF. PER FOLLOW UP INFORMATION RECEIVED VIA MAIL ON 19MAR2025, NURSE HAD THROWN AWAY THE GEL PAD, SO THEY DON¿T HAVE THE SAMPLE TO RETURN TO BD APPROVED FACILITY. THE ISSUE WAS RESOLVED. SINCE THAT WAS AN EMERGENCY AND THEY DID NOT HAVE ANOTHER GEL PAD, SO THE DOCTOR DECIDED TO USE THE FLABBY GEL PAD FOR PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22842326 ↗
• MalfunctionAug 11, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THERE WAS A POOR ADHESION IN AN ARCTIC GEL PAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22773227 ↗
• MalfunctionAug 11, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE RN OPENED BRAND NEW ARCTIC SUN PAD AND THE ADHESIVE COVER WAS NOT ON THE PAD CORRECTLY. THE STICKY MATERIAL WAS DEFECTIVE. PER FOLLOW UP INFORMATION RECEIVED VIA MAIL ON 10JUN2025, THEY RECEIVED ONE KIT WHICH THEY SENT BACK WITH SAMPLE. RECENTLY THEY RECEIVED ANOTHER DEFECTED PAD AND IN NEED FOR ANOTHER KIT TO MAIL IT BACK. SAMPLE WILL BE RETURNING.

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

  MAUDE report 22773221 ↗
• MalfunctionAug 11, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT THE LEG PAD WAS DEFECTIVE. THE GEL LAYER REMOVED FROM THE ARCTIC GEL PAD BEFORE USING. PER FOLLOW UP INFORMATION RECEIVED VIA TASK ON 31MAR2025, LOT# OF THE DEFECTIVE PRODUCT WAS NGHV1057.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22771018 ↗
• MalfunctionAug 7, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE ARCTIC GEL PAD HAD A LEAK AIR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22741593 ↗
• MalfunctionJul 31, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT THE ARCTIC GEL LAYER WAS STILL USED BECAUSE THERE WERE NO OTHER SPARE PARTS. GEL LAYER SEPARATION. THE INCIDENT OCCURRED BEFORE USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22675991 ↗