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Arctic Sun® Temperature Management System Assy, Cable, Temp Out, Phono Plug GE 73555Recalls & reported problems

Medivance, Inc. · Arctic Sun® Temperature Management System Assy, Cable, Temp Out, Phono Plug GE · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
3
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741080371), received between Mar 18, 2021 and Mar 18, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Inadequate Instructions for Healthcare Professional” (3 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

Device problems

  • Inadequate Instructions for Healthcare Professional3

Patient problems

  • No Clinical Signs, Symptoms or Conditions3

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMar 18, 2021Inadequate Instructions for Healthcare Professional; Inadequate Instructions for Healthcare Professional

    IT WAS REPORTED THAT THE ARCTIC SUN DEVICE CABLES WERE LABELED AS GE AND 735-55 BUT THE ACTUAL CABLE INSIDE THE PACKAGE WAS FOR PHILIPS. COMPLAINANT REPORTED THAT THEY HAVE RECEIVED TWO OF THESE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11519983 ↗
  • MalfunctionMar 18, 2021Inadequate Instructions for Healthcare Professional; Inadequate Instructions for Healthcare Professional

    IT WAS REPORTED THAT THE CUSTOMER ORIGINALLY ORDERED A QUANTITY OF 2 WITH PRODUCT NUMBER 735-55, TEMPERATURE OUT PHONO PLUG GE. STATED THAT THE ORDER RECEIVED THROUGH PARTSSOURCE, THE BOX CONTAINED 2 BAGS BOTH IDENTIFIED AS 735-55 HOWEVER THEY CONTAINED 2 DIFFERENT PARTS. ONE WAS THE GE PHONO JACK 735-55 WHAT WAS DEPICTED IN THE ATTACHMENT. THE OTHER WAS A 735-56, PHILIPS CONNECTOR IN WHICH THE BAG MARKED 755-55. THE USER JUST RECEIVED THE REPLACEMENT PART AND IT HAD THE SAME ISSUE, RECEIVED A BAG MARKED 735-55 WITH THE PHILIPS CONNECTOR, 735-56.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11517005 ↗
  • MalfunctionMar 18, 2021Inadequate Instructions for Healthcare Professional; Inadequate Instructions for Healthcare Professional

    IT WAS REPORTED THAT THE CUSTOMER ORIGINALLY ORDERED A QUANTITY OF 2 WITH PRODUCT NUMBER 735-55, TEMPERATURE OUT PHONO PLUG GE. STATED THAT THE ORDER RECEIVED THROUGH PARTSSOURCE, THE BOX CONTAINED 2 BAGS BOTH IDENTIFIED AS 735-55 HOWEVER THEY CONTAINED 2 DIFFERENT PARTS. ONE WAS THE GE PHONO JACK 735-55 WHAT WAS DEPICTED IN THE ATTACHMENT. THE OTHER WAS A 735-56, PHILIPS CONNECTOR IN WHICH THE BAG MARKED 755-55. THE USER JUST RECEIVED THE REPLACEMENT PART AND IT HAD THE SAME ISSUE, RECEIVED A BAG MARKED 735-55 WITH THE PHILIPS CONNECTOR, 735-56.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11517003 ↗

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Sources and updates

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