Arctic Sun® Temperature Management System, Temperature Out Cable Philips 73556Recalls & reported problems
Medivance, Inc. · Arctic Sun® Temperature Management System, Temperature Out Cable Philips · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741080388), received between Aug 31, 2023 and May 11, 2026 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Device Sensing Problem” (4 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.
Reports received per month
Most reported problems
Device problems
- Device Sensing Problem4
- Failure to Sense3
- Material Fragmentation1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 11, 2026Device Sensing Problem
IT WAS REPORTED THAT THE NURSE WAS TRYING TO CONNECT PATIENT OUT CABLE TO THE PHILIPS MONITOR. IT PLUGGED INTO THE MONITOR, BUT PATIENT TEMPERATURE WAS NOT DISPLAYING IN AN ARCTIC SUN DEVICE. NURSE WAS NOT SURE IF THEY SHOULD CALL PHILIPS TO TROUBLESHOOT. CONFIRMED THEY WERE USING THE BLACK TEMPERATURE OUT CABLE. IT WAS PLUGGED INTO THE TEMPERATURE OUT PORT ON BACK OF MACHINE. EXPLAINED IT MIGHT BE SOMETHING THEY NEED TO ENABLE ON THE PHILIPS MONITOR. SUGGESTED THEY ALSO TRY ANOTHER TEMPERATURE OUT CABLE TO ENSURE IT WAS NOT A CABLE ISSUE IF THEY WERE STILL HAVING TROUBLE. PER FOLLOW UP INFORMATION RECEIVED VIA TASK ON 06MAY2026, SPOKE WITH NURSE WHO CONFIRMED A FAULTY CABLE WAS IDENTIFIED. THEY USED A CABLE FROM ANOTHER DEVICE AND THE TEMPERATURE DISPLAYED ON THE MONITOR. THE CABLE WAS DISPOSED OF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25144098 ↗MalfunctionSep 22, 2025Failure to Sense; Device Sensing Problem; Failure to Sense; Device Sensing Problem
IT WAS REPORTED THAT THERE WAS A DIFFERENCE IN THE PATIENT TEMPERATURE DISPLAYED ON THE PATIENT MONITOR CONNECTED TO ARCTIC SUN DEVICE STAT. PER REVIEW OF WO ON 10SEP2025, THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23109125 ↗MalfunctionSep 12, 2025Failure to Sense; Device Sensing Problem; Failure to Sense; Device Sensing Problem
IT WAS REPORTED THAT PATIENT TEMPERATURE WAS NOT DISPLAYED ON THE PATIENT MONITOR CONNECTED TO ARCTIC SUN DEVICE STAT. PER REVIEW OF WO ON 10SEP2025, THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23038650 ↗MalfunctionSep 12, 2025Failure to Sense; Device Sensing Problem; Failure to Sense; Device Sensing Problem
IT WAS REPORTED THAT THE PATIENT TEMPERATURE WAS NOT DISPLAYED ON THE PATIENT MONITOR CONNECTED TO ARCTIC SUN DEVICE STAT. PER REVIEW OF WO ON 10SEP2025, THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23038493 ↗MalfunctionAug 31, 2023Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE BIOMED STATED THAT THEY HAD A CABLE WITH THE ARCTIC SUN DEVICE THAT THE END WAS PULLED OFF. BIOMED DESCRIBED IT AS A GREY CABLE WITH ONE WHITE END AND ONE GREY AND BLACK END. BIOMED STATED THAT IT HAD A NUMBER ON THE CABLE, BUT IT DID NOT PULL UP IN THE SYSTEM AS THE PRODUCT CODE. BIOMED PROVIDED THE NUMBER DY00073556. CONFIRMED WITH BIOMED IT SOUNDS LIKE A TEMPERATURE OUT CABLE. PRODUCT CODE 735-56 WAS THE PRODUCT CODE FOR THE PHILIPS CONNECTION TEMPERATURE OUT CABLE. EMAILED THE TTM TEMPERATURE CABLES BROCHURE AND DIRECTED TO THE PAGE IN THE SERVICE MANUAL FOR BIOMED TO CONFIRM IT WAS THE APPROPRIATE CONNECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17661250 ↗
Other System, thermal regulating devices
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- Arctic Sun® 5000 50000000LMedivance, Inc. · System, thermal regulating1 recall388 reports
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- Altrix 8001Stryker Corporation · System, thermal regulating1 recall160 reports
- Arctic Sun Stat 60000000LMedivance, Inc. · System, thermal regulating1 recall104 reports
- HotDog Temperature Management System WC77Augustine Temperature Management LLC · System, Thermal Regulating2 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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