TOSCA sensor 92 5621000Recalls & reported problems
Radiometer Medical ApS · TOSCA sensor 92 · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05700693096131), received between Sep 12, 2018 and Jun 26, 2019 — classified as 2 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).
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 16, 2026.
Most reported problems
Device problems
- Insufficient Device Problem Information1
- Use of Device Problem1
Patient problems
- Burn(s)2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 26, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT A PATIENT RECEIVED A SKIN BURN ON THE EARLOBE. THE HOSPITAL CONFIRMED THAT THE SKIN BURN CAUSED A BLISTER.
Patient problems: Burn(s)
MAUDE report 8735497 ↗InjurySep 12, 2018Use of Device Problem; Use of Device Problem
IT IS REPORTED THAT AN ELDERLY PATIENT RECEIVED A BURN MARK ON THE EARLOBE FROM A TC SENSOR. IN THE TCM TOSCA/COMBIM OPERATOR'S MANUAL (SOFTWARE VERSION 3.00, PUBLICATION 201504, EDITION E) IT IS STATED THAT THE RECOMMENDED MAXIMUM APPLICATION TIME IS 8 HOURS AT A SENSOR SKIN INTERFACE TEMPERATURE OF 42 DEGREES CELSIUS. ACCORDING TO THE HOSPITAL THE SENSOR WAS APPLIED FOR 12 HOURS OR MORE AT A TEMPERATURE OF 42 DEGREES CELSIUS AND THIS IS BELIEVED TO BE THE CAUSE OF THE BURN. THE DEVICE WAS CHECKED, BUT NO PROBLEMS WAS FOUND. THE SENSOR AND MONITOR HAS BEEN SENT TO RADIOMETER FOR INVESTIGATION.
Patient problems: Burn(s)
MAUDE report 7867822 ↗
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- HAMILTON-G5 159002Hamilton Medical AG · Oximeter3 deaths451 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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