Fisher & Paykel Healthcare OPT980ERecalls & reported problems
Fisher & Paykel Healthcare Limited · Optiflow Mask Interface Adapter (Single) · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 09420012436948), received between Jan 27, 2021 and Apr 27, 2023 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Break” (6 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 18, 2026.
Most reported problems
Device problems
- Break6
- Detachment of Device or Device Component2
- Material Split, Cut or Torn2
Patient problems
- No Clinical Signs, Symptoms or Conditions7
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 27, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
A CONSUMER REPORTED THAT THE TUBING OF AN OPT980E OPTIFLOW + MASK INTERFACE ADAPTER WAS FOUND DAMAGED DURING USE. THERE WERE NO REPORTED PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16828558 ↗MalfunctionJan 20, 2022Detachment of Device or Device Component; Break; Detachment of Device or Device Component
A DISTRIBUTOR IN (B)(4) REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE TUBING OF AN OPT980E OPTIFLOW + MASK INTERFACE ADAPTER WAS FOUND DAMAGED DURING PATIENT USE. THERE WERE NO REPORTED PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13310192 ↗MalfunctionDec 22, 2021Break; Material Split, Cut or Torn; Material Split, Cut or Torn
A DISTRIBUTOR REPORTED ON BEHALF OF AN END-USER IN KANSAS, VIA A FISHER & PAYKEL HEALTHCARE (F&P) REPRESENTATIVE, THAT THE TUBING OF FOUR OPT980E OPTIFLOW + MASK INTERFACE ADAPTERS WERE FOUND DAMAGED DURING USE. THERE WERE NO REPORTED PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13066493 ↗MalfunctionSep 12, 2021Break; Detachment of Device or Device Component; Detachment of Device or Device Component
A DISTRIBUTOR IN CANADA REPORTED VIA A FISHER AND PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE TUBING OF AN OPT980E OPTIFLOW + MASK INTERFACE ADAPTOR WAS FOUND DAMAGED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12458024 ↗MalfunctionApr 15, 2021Break
A DISTRIBUTOR IN CANADA REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) REPRESENTATIVE THAT AN OPT980 MASK INTERFACE ADAPTER BROKE BETWEEN THE TUBING AND CONNECTOR. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11676207 ↗MalfunctionJan 27, 2021Break
A DISTRIBUTOR IN CANADA REPORTED, VIA A FISHER & PAYKEL HEALTHCARE (F&P) REPRESENTATIVE, THAT TWO OPT980E OPTIFLOW + MASK INTERFACE ADAPTERS WERE "COMING APART AT THE BASE OF THE TUBING" DURING USE. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11241286 ↗MalfunctionJan 27, 2021Break
A DISTRIBUTOR IN (B)(4) REPORTED, VIA A FISHER & PAYKEL HEALTHCARE (F&P) REPRESENTATIVE, THAT OPT980 MASK INTERFACE ADAPTERS WERE "COMING APART AT THE BASE OF THE TUBING" DURING USE. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11240994 ↗
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- 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 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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