Fisher & Paykel Healthcare RT219Recalls & reported problems
Fisher & Paykel Healthcare Limited · Bi-level/CPAP circuit · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 09420012430311), received between Apr 9, 2021 and Apr 9, 2021 — classified as 1 death.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Improper or Incorrect Procedure or Method1
- Misconnection1
Patient problems
- Insufficient Information1
- Viral Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathApr 9, 2021Misconnection; Improper or Incorrect Procedure or Method; Misconnection
A HEALTHCARE FACILITY IN WISCONSIN REPORTED THAT THE RT219 ADULT BI-LEVEL/CPAP BREATHING CIRCUIT BECAME UNINTENTIONALLY DISCONNECTED FROM THE BIPAP MASK. IT WAS FURTHER REPORTED THAT THE CIRCUIT WAS RECONNECTED TO THE FILTER INSTEAD OF THE BIPAP MASK. THE PATIENT WAS IN COVID ISOLATION AND HAS SINCE PASSED AWAY.
Patient problems: Insufficient Information; Viral Infection
MAUDE report 11639470 ↗
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- 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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