F&P Optiflow+ OPT942ERecalls & reported problems
Fisher & Paykel Healthcare Limited · Optiflow Nasal Cannula Small (Single) · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 09420012429711), received between Jul 12, 2023 and Jul 12, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Incomplete or Inadequate Connection” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Incomplete or Inadequate Connection1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 12, 2023Incomplete or Inadequate Connection; Incomplete or Inadequate Connection
A PATIENT IN NORTH CAROLINA REPORTED THAT THE MANIFOLD OF AN OPT942E OPTIFLOW + ADULT NASAL CANNULA HAD A LOOSE CONNECTION WITH THE INTERFACE. THE PATIENT REPORTED THAT THEY HAD BEEN USING THE SUBJECT CANNULA TWICE A DAY FOR SEVERAL MONTHS WITHOUT THE HEAD STRAP CLIP. THERE WERE NO REPORTED PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17313654 ↗
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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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