Arctic Sun® Temperature Management System, Calibration Test Unit 74100Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00801741080418), received between Aug 31, 2018 and Sep 4, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Defective Component” (2 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 4, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE BIOMED NEEDS QUOTE TO SEND IN CALIBRATION TEST UNIT (CTU) FOR CALIBRATION AND REPAIR STATED CLIP ON BLACK CABLE WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22964642 ↗
• MalfunctionApr 13, 2023Wrong Label; Wrong Label

  IT WAS REPORTED THAT THE CALIBRATION TESTING UNIT HAS THE WRONG CALIBRATION LABEL ON IT. IT WAS MARKED AS SERIAL NUMBER (B)(6) WHEN OPENED THE INNER LABEL WAS SERIAL NUMBER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16732359 ↗
• MalfunctionMar 21, 2023Inadequate Instructions for Healthcare Professional; Inadequate Instructions for Healthcare Professional

  IT WAS REPORTED THAT THE AFTER CALIBRATION DURING RELABELING OF THE UNIT IT WAS FOUND THAT THE LABELS ON THE OUTSIDE OF THE UNIT WITH SERIAL NUMBER (B)(6) DO NOT MATCH WHAT WAS ON THE INSIDE OF THE UNIT SERIAL NUMBER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16582193 ↗
• MalfunctionFeb 8, 2023Inaccurate Flow Rate; Defective Component; Inaccurate Flow Rate; Defective Component

  IT WAS REPORTED THAT THE CALIBRATION TEST UNIT FAILED INITIAL ELECTRICAL SAFETY TESTING, REQUIRING THE HEATER HARNESS TO BE REPLACED WHICH WAS DUE TO AN UNKNOWN FAILURE IN THE HEATER HARNESS. THE ROOT CAUSE WAS DUE TO THE CALIBRATION OF THE UNIT HAD EXPIRED. PER SAMPLE EVALUATION RESULTS RECEIVED ON 20-JAN-2023, THE ROOT CAUSE OF THE REPORTED ISSUE WAS A FAILED HEATER POWER HARNESS. IT WAS STATED THAT DURING FLOW CALIBRATION OF THE UNIT, IT EXHIBITED LOW FLOW, WHICH REQUIRED THE MANIFOLD TO BE REPLACED. IT WAS STATED THAT THE POWER ENTRY MODULE NEEDED TO BE REPLACED DUE TO PREVENTATIVE MAINTENANCE. IT WAS NOTED THAT THE HEATER POWER HARNESS, MANIFOLD, AND POWER ENTRY MODULE WERE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16325864 ↗
• MalfunctionJan 13, 2023Defective Component; Defective Component

  IT WAS REPORTED THAT THE ARCTIC SUN DEVICE FAILED ELECTRICAL SAFETY TEST AND HEATER POWER HARNESS WOULD BE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16159222 ↗
• MalfunctionDec 2, 2022Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE CALIBRATION TEST UNIT FAILS THE TEMPERATURE PROBE TEST. THE ROOT CAUSE WAS FAULTY CCA BOARD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15902210 ↗
• MalfunctionOct 27, 2022Inadequate Instructions for Healthcare Professional; Improper or Incorrect Procedure or Method; Inadequate Instructions for Healthcare Professional; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PICTURE OF CALIBRATION TESTING UNIT LABEL SHOWING THAT ONE OF THE DIGITS WAS INCORRECTLY TYPED ONTO THE LABEL MAKING IT IMPOSSIBLE TO BE USED TO CALIBRATE DEVICE. IT APPEARED THAT AN ERROR WAS MADE WHEN CREATING THE LABEL DURING THE PREVIOUS CALIBRATION. MSS STATED WE WOULD BRING BACK THE CALIBRATION TESTING UNIT UNDER WARRANTY AND RECALIBRATE IT. PER EMAIL RESPONSE RECEIVED ON (B)(6) 2022. THERE WAS NO PATIENT INVOLVEMENT. DEVICE WOULD BE RETURNED WITH LABEL, AND PHOTO OF LABEL WAS ATTACHED. LETTER D ON LABEL APPEARED TO BE INCORRECT, VALUE WAS LISTED AS .9.96. PER TECH SUPPORT THE VALUE SHOULD BE 39.96.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15679466 ↗
• MalfunctionSep 17, 2018Electrical /Electronic Property Problem; Calibration Problem; Failure of Device to Self-Test

  IT WAS REPORTED THAT THE UNIT WAS RETURNED FOR CALIBRATION AND IT FAILED THE ELECTRICAL SAFETY TEST. UPON COMPLETION ON THE INVESTIGATION, THE ISSUE WAS FOUND TO BE A FAULTY HEATER HARNESS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7880819 ↗
• MalfunctionSep 14, 2018Device Difficult to Program or Calibrate; Temperature Problem

  IT WAS REPORTED THAT THE UNIT WAS COMING BACK FOR RE-CALIBRATION, AND THE HEATER HARNESS FAILED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7876792 ↗
• MalfunctionAug 31, 2018Defective Device

  IT WAS REPORTED THAT THE UNIT WAS COMING BACK FOR CALIBRATION, AND THE HEATER HARNESS FAILED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7839182 ↗