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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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 3 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 1 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520263
Last 36 months. The most recent month may be incomplete.

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 ↗

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Sources and updates

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