F&P Optiflow+ OPT946Recalls & reported problems
Fisher & Paykel Healthcare Limited · Optiflow Nasal Cannula Large · Class 2
Quick summary
This Fisher & Paykel Optiflow+ nasal cannula is used to deliver warmed, humidified breathing gases. The 24 reports describe tubing that splits, tears or breaks and parts that detach, with a few mentions of low oxygen levels, and list no deaths and no injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 23
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 09420012429155), received between Jun 7, 2017 and Mar 5, 2026 — classified as 23 malfunctions.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (16 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.
Reports received per month
Most reported problems
Device problems
- Material Split, Cut or Torn16
- Break6
- Detachment of Device or Device Component3
- Degraded1
- Device Issue1
- Disconnection1
- Fitting Problem1
- Gas/Air Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions17
- Low Oxygen Saturation4
- No Consequences Or Impact To Patient1
- Pneumonia1
Recent adverse event reports
The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 5, 2026Material Split, Cut or Torn
A HEALTHCARE FACILITY IN FRANCE REPORTED VIA A FISHER AND PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE TUBING OF AN OPT946 OPTIFLOW + ADULT NASAL CANNULA WAS FOUND DAMAGED BEFORE PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT AS THE ISSUE WAS FOUND WHILST THE DEVICE WAS NOT IN USE ON A PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24527684 ↗MalfunctionMar 2, 2026Detachment of Device or Device Component
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN JAPAN VIA A FISHER AND PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE TUBING OF AN OPT946 OPTIFLOW + ADULT NASAL CANNULA WAS FOUND DETACHED. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24479719 ↗MalfunctionFeb 11, 2026Detachment of Device or Device Component; Material Split, Cut or Torn
A HEALTHCARE FACILITY IN ITALY REPORTED THAT THE HEADGEAR OF AN OPT946 OPTIFLOW + ADULT NASAL CANNULA WAS FOUND BROKEN AND DETACHED FROM THE INTERFACE. THERE WERE NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24317284 ↗MalfunctionFeb 14, 2024Detachment of Device or Device Component; Material Split, Cut or Torn; Detachment of Device or Device Component; Material Split, Cut or Torn
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN JAPAN VIA A FISHER AND PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE TUBING OF AN OPT946 OPTIFLOW + ADULT NASAL CANNULA WAS FOUND DAMAGED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT AS THE ISSUE WAS FOUND WHILST THE DEVICE WAS NOT IN USE ON A PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18707163 ↗MalfunctionDec 20, 2023Disconnection; Disconnection
A HEALTHCARE FACILITY IN THE UNITED KINGDOM REPORTED THAT ON (B)(6) 2023 THE OPT946 OPTIFLOW + ADULT NASAL CANNULA TUBE HAD DISCONNECTED FROM THE NASAL PRONGS DURING PATIENT USE. ON (B)(6) 2023, THE HEALTHCARE FACILITY FURTHER REPORTED THE FOLLOWING SEQUENCE OF EVENTS. ON (B)(6) 2023, THE NURSE OBSERVED THE OPT946 OPTIFLOW + ADULT NASAL CANNULA PRONGS TO BE FUNCTIONING AS INTENDED. AT EARLY HOURS OF THE MORNING, THE NURSE OBSERVED THE PATIENT TO HAVE UNUSUAL BREATHING, FURTHERMORE A DOCTOR OBSERVED THE PATIENT TO HAVE CYANOSIS AND AGONAL BREATHING. IT WAS REPORTED THAT THE OPT946 OPTIFLOW + ADULT NASAL CANNULA TUBE HAD DISCONNECTED FROM THE NASAL PRONGS AND WAS RECONNECTED IMMEDIATELY. IT WAS FURTHER REPORTED BY THE HEALTHCARE FACILITY THAT THE PATIENT PASSED AWAY, AND THE MEDICAL CAUSE OF DEATH WAS PNEUMONIA.
Patient problems: Pneumonia
MAUDE report 18367098 ↗MalfunctionFeb 9, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
A HEALTHCARE FACILITY IN QUEBEC REPORTED, VIA A FISHER AND PAYKEL HEALTHCARE FIELD REPRESENTATIVE, THAT THE TUBING OF AN OPT946 + ADULT NASAL CANNULAS WERE FOUND DAMAGED AFTER 4 DAYS USE ON A PATIENT AND THE PATIENT DESATURATED. THE HEALTHCARE FACILITY ALSO REPORTED THAT THE DAMAGED CANNULA WAS REPLACED AND THERE WAS NO HARM TO THE PATIENT.
Patient problems: Low Oxygen Saturation
MAUDE report 16345003 ↗MalfunctionFeb 9, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
A HEALTHCARE FACILITY IN CANADA REPORTED, VIA A FISHER AND PAYKEL HEALTHCARE FIELD REPRESENTATIVE, THAT THE TUBING OF TWO OPT946 + ADULT NASAL CANNULAS WERE FOUND DAMAGED AFTER 4 HOURS USE ON A PATIENT. THE HEALTHCARE FACILITY ALSO REPORTED THAT THE PATIENT DESATURATED, BUT THERE WAS NO HARM TO THE PATIENT.
Patient problems: Low Oxygen Saturation
MAUDE report 16344877 ↗MalfunctionFeb 6, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
A HEALTHCARE FACILITY IN TAIWAN REPORTED VIA A FISHER AND PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE TUBING OF AN OPT946 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 16309508 ↗MalfunctionFeb 6, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
A HEALTHCARE FACILITY IN TAIWAN REPORTED VIA A FISHER AND PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE TUBING OF AN OPT946 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 16309507 ↗MalfunctionFeb 6, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
A HEALTHCARE FACILITY IN TAIWAN REPORTED VIA A FISHER AND PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE TUBING OF AN OPT946 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 16309506 ↗MalfunctionJan 19, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
A HEALTHCARE FACILITY IN NETHERLANDS REPORTED VIA A FISHER AND PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE TUBING OF AN OPT946 OPTIFLOW + ADULT NASAL CANNULA WAS FOUND DAMAGED BEFORE PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT AS THE ISSUE WAS FOUND WHILST THE DEVICE WAS NOT IN USE ON A PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16210419 ↗MalfunctionJan 19, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
A HEALTHCARE FACILITY IN NETHERLANDS REPORTED VIA A FISHER AND PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE TUBING OF AN OPT946 OPTIFLOW + ADULT NASAL CANNULA WAS FOUND DAMAGED BEFORE PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT AS THE ISSUE WAS FOUND WHILST THE DEVICE WAS NOT IN USE ON A PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16210415 ↗MalfunctionSep 1, 2022Loose or Intermittent Connection; Fitting Problem; Loose or Intermittent Connection; Fitting Problem
A HEALTHCARE FACILITY IN TEXAS REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT AN OPT946 OPTIFLOW + ADULT NASAL CANNULA WAS FOUND TO HAVE A LOOSE CONNECTION WITH THE HEATED BREATHING TUBE AS PART OF THE 900PT561 HEATED BREATHING TUBE DURING DEVICE SET UP. THE CANNULA WAS REPLACED. IT WAS FURTHER REPORTED BY THE HEALTHCARE FACILITY THAT THE CANNULA WAS MANUFACTURED IN 2015. THERE WAS NO PATIENT CONSEQUENCE AS THE EVENT OCCURED DURING DEVICE SET UP WHILE THE PATIENT REMAINED ON NIV THERAPY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15343393 ↗MalfunctionAug 1, 2022Break; Gas/Air Leak; Material Split, Cut or Torn; Break
A DISTRIBUTOR IN JAPAN REPORTED ON BEHALF OF A HEALTHCARE FACILTY VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE TUBING OF AN OPT946 OPTIFLOW + ADULT NASAL CANNULA HAD TORN AND THERE WAS A LEAK. THE PATIENT DESATURATED TO THE 80% SPO2 RANGE. THE OPT946 OPTIFLOW + ADULT NASAL CANNULA WAS REPLACED WITH A NEW ONE AND THE PATIENTS SPO2 RECOVERED TO NORMAL RANGE. NO FURTHER PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: Low Oxygen Saturation
MAUDE report 15142990 ↗MalfunctionFeb 3, 2022Material Split, Cut or Torn; Break; Material Split, Cut or Torn
A HEALTHCARE FACILITY IN AUSTRIA REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE TUBING OF AN OPT946 OPTIFLOW + ADULT NASAL CANNULA WAS FOUND DAMAGED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13436922 ↗MalfunctionOct 14, 2021Material Split, Cut or Torn; Material Split, Cut or Torn
A HEALTHCARE FACILITY IN (B)(4) REPORTED THAT THE TUBING OF AN OPT946 OPTIFLOW + ADULT NASAL CANNULA WAS FOUND TORN AND THE PATIENT DESATURATED TO BELOW 90% SPO2. THE PATIENT WAS PROVIDED THERAPY WITH A NON-REBREATHER MASK WHILST THE CANNULA WAS REPLACED. THERE WAS NO FURTHER PATIENT CONSEQUENCE.
Patient problems: Low Oxygen Saturation
MAUDE report 12637455 ↗MalfunctionSep 9, 2021Degraded; Mechanical Problem; Degraded
A HEALTHCARE FACILITY IN MISSISSIPPI REPORTED VIA A FISHER AND PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THREE OPT946 OPTIFLOW + ADULT NASAL CANNULAS WERE FOUND DAMAGED DURING PATIENT USE. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12444551 ↗MalfunctionAug 12, 2021Break; Material Split, Cut or Torn; Material Split, Cut or Torn
A DISTRIBUTOR IN COLUMBIA REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT NASAL PRONG OF AN OPT946 OPTIFLOW + ADULT NASAL CANNULA WAS DAMAGED. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12316293 ↗MalfunctionJul 1, 2021Material Split, Cut or Torn; Material Split, Cut or Torn
A HEALTHCARE FACILITY IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE TUBING OF AN OPT946 OPTIFLOW + ADULT NASAL CANNULA WAS FOUND BROKEN BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12105244 ↗MalfunctionDec 22, 2020Break; Break
A HEALTHCARE FACILITY IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT AN OPT946 NASAL CANNULA BROKE AFTER TWO DAYS OF USE. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11060101 ↗MalfunctionDec 3, 2020Break; Stretched; Material Split, Cut or Torn; Material Split, Cut or Torn
A HEALTHCARE FACILITY IN WASHINGTON REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE TUBING OF TWO OPT944 NASAL CANNULA WERE STRETCHED OUT AND WERE DAMAGED. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10937592 ↗MalfunctionSep 24, 2020Break; Break
A DISTRIBUTOR IN AUSTRALIA REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE OPT946 OPTIFLOW + ADULT NASAL CANNULA NASAL PRONGS DISCONNECTED FROM THE MANIFOLD DURING PATIENT USE. IT WAS REPORTED THAT THERE WAS AN INTERRUPTION TO THE PATIENT'S THERAPY. THERE WERE NO FURTHER REPORTED PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10582408 ↗MalfunctionJun 7, 2017Device Issue; Device Issue
A HOSPITAL IN THE (B)(6) REPORTED VIA THE (B)(4) REGULATORY BODY, (B)(4) THAT THE TUBING OF AN OPT946 NASAL CANNULA DETACHED FROM THE DISTAL CONNECTOR THAT ATTACHES TO THE BREATHING CIRCUIT. IT WAS CONFIRMED THAT THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6617136 ↗
Other Humidifier, Respiratory Gas, (Direct Patient Interface) devices
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- 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
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.