F&P Optiflow+ OPT946ERecalls & reported problems
Fisher & Paykel Healthcare Limited · Optiflow Nasal Cannula Large (Single) · Class 2
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 09420012429742), received between Sep 22, 2021 and Dec 4, 2022 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (4 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Material Split, Cut or Torn4
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Low Oxygen Saturation1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 4, 2022Material Split, Cut or Torn; Material Split, Cut or Torn
A DISTRIBUTOR IN POLAND REPORTED, VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE TUBING OF AN OPT946E OPTIFLOW + ADULT NASAL CANNULA WAS FOUND DAMAGED DURING USE. THERE WERE NO REPORTED PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15912746 ↗MalfunctionNov 23, 2022Material Split, Cut or Torn; Material Split, Cut or Torn
A DISTRIBUTOR REPORTED IN POLAND VIA A FISHER AND PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE TUBING OF AN OPT946E OPTIFLOW + ADULT NASAL CANNULA WAS FOUND DAMAGED DURING PATIENT USE. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15850066 ↗MalfunctionOct 31, 2022Material Split, Cut or Torn; Material Split, Cut or Torn
A DISTRIBUTOR IN POLAND REPORTED, VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE TUBING OF AN OPT946E OPTIFLOW + ADULT NASAL CANNULA WAS FOUND DAMAGED DURING USE. THERE WERE NO REPORTED PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15705304 ↗MalfunctionSep 22, 2021Break; Material Split, Cut or Torn; Break
A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT AN OPT946 OPTIFLOW + ADULT NASAL CANNULA HAD TORN. THE PATIENT'S OXYGEN SATURATION DECREASED TO 84% SPO2 AND IMPROVED ONCE THE OPT946 OPTIFLOW + ADULT NASAL CANNULA WAS REPLACED. NO FURTHER PATIENT CONSEQUENCES WAS REPORTED.
Patient problems: Low Oxygen Saturation
MAUDE report 12517129 ↗
Other Humidifier, Respiratory Gas, (Direct Patient Interface) devices
- Fisher & Paykel Healthcare PT101USFisher & Paykel Healthcare Limited · Humidifier, Respiratory Gas, (Direct Patient Interface)2 recalls5 deaths1,068 reports
- HUDSON RCI IPN913776Teleflex Incorporated · HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)436 reports
- F&P Optiflow+ OPT944Fisher & Paykel Healthcare Limited · Humidifier, Respiratory Gas, (Direct Patient Interface)5 deaths392 reports
- Fisher & Paykel Healthcare PT100USFisher & Paykel Healthcare Limited · Humidifier, Respiratory Gas, (Direct Patient Interface)2 recalls59 reports
- MR850 MR850JHUFisher & Paykel Healthcare Limited · Humidifier, Respiratory Gas, (Direct Patient Interface)93 reports
- HUDSON RCI HUD42500Medline Industries, Inc. · HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)87 reports
- F&P Optiflow Junior 2 OJR412Fisher & Paykel Healthcare Limited · Humidifier, Respiratory Gas, (Direct Patient Interface)80 reports
- F&P Optiflow Junior 2 OJR414Fisher & Paykel Healthcare Limited · Humidifier, Respiratory Gas, (Direct Patient Interface)56 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.