Electrode for ABL analyzers 945-605Recalls & reported problems
Radiometer Medical ApS · E5250-0 TC pO2 electrode · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05700699456052), received between Jan 28, 2019 and Nov 15, 2019 — classified as 3 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 16, 2026.
Most reported problems
Device problems
- Insufficient Device Problem Information3
Patient problems
- Burn(s)2
- Burn, Thermal2
- Burning Sensation1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryNov 15, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
ACCORDING TO THE COMPLAINT, THE SKIN OF THE PATIENT WAS SLIGHTLY BURNED DURING TRANSCUTANEOUS OXYGEN MEASUREMENT ULTIMATELY LEAVING A BLISTER.
Patient problems: Burning Sensation
MAUDE report 9326072 ↗InjuryJan 28, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
ACCORDING TO THE COMPLAINT RECEIVED, A PATIENT SENSOR BURN FROM A TCPO2 SENSOR USED WITH A TCM400 MONITOR WAS REPORTED. A (B)(6) YEAR-OLD FEMALE PATIENT BEING TREATED FOR CHRONIC REFRACTORY OSTEOMYELITIS WAS SUBJECTED TO IN-CHAMBER TREATMENT ON (B)(6) 2019, WHERE A TCM400 MONITOR WAS APPLIED. ON (B)(6) 2019 THE PATIENT CAME BACK FROM HYPERBARIC OXYGEN TREATMENT AND A WOUND WAS IDENTIFIED ON HER LEG IN THE AREA WHERE THE SENSOR WAS PLACED. THE PATIENT WAS ADMITTED TO THE WOUND CARE CENTER WHERE THE WOUND CURRENTLY IS BEING TREATED.
Patient problems: Burn(s); Burn, Thermal
MAUDE report 8280937 ↗InjuryJan 28, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
ACCORDING TO THE COMPLAINT RECEIVED, A PATIENT SENSOR BURN FROM A TCPO2 SENSOR USED WITH A TCM400 MONITOR WAS REPORTED. A (B)(6) YEAR-OLD FEMALE PATIENT BEING TREATED FOR CHRONIC REFRACTORY OSTEOMYELITIS WAS SUBJECTED TO IN-CHAMBER TREATMENT ON (B)(6) 2019, WHERE A TCM400 MONITOR WAS APPLIED. ON (B)(6) 2019, THE PATIENT CAME BACK FROM HYPERBARIC OXYGEN TREATMENT AND A WOUND WAS IDENTIFIED ON HER LEG IN THE AREA WHERE THE SENSOR WAS PLACED. THE PATIENT WAS ADMITTED TO THE WOUND CARE CENTER WHERE THE WOUND CURRENTLY IS BEING TREATED.
Patient problems: Burn(s); Burn, Thermal
MAUDE report 8280617 ↗
Other Monitor, oxygen, cutaneous, for uses other than for infant not under gas anesthesia devices
- Multi-Site Attachment Ring for mature/intact skin MARe-MISenTec AG · Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia1 death1 report
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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