Microstream 015179_RMS1Recalls & reported problems
Oridion Medical 1987 Ltd. · ORIDION: SMART CAPNOLINE PLUS O2 ADULT/INT · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20884521551906), received between Sep 17, 2020 and Sep 17, 2020 — classified as 1 injury.
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Chest Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 17, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ACCORDING TO THE REPORTER, DURING USE, THERE WAS EXTREMELY STRONG CHEMICAL SMELL AS REPORTED TO QUALITY AND PATIENT SAFETY. SMELL GAVE PATIENT A HEAVY CHEST AND INCREASED SHORTNESS OF BREATH.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Chest Pain
MAUDE report 10545416 ↗
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- NA GF-210RNihon Kohden Corporation · ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE386 reports
- Trilogy IT2110X21BRespironics, Inc. · ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE5 recalls30 reports
- Trilogy Trilogy Evo Ventilator, GermanyRespironics, Inc. · ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE5 recalls26 reports
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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