Fisher & Paykel Healthcare 900PT563Recalls & reported problems
Fisher & Paykel Healthcare Limited · AirSpiral Tube and Chamber Kit with Nebulizer Adapter · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 09420012463159), received between Jan 25, 2024 and Apr 2, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Melted” (2 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.
Reports received per month
Most reported problems
Device problems
- Melted2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 2, 2024Melted; Melted
A HEALTHCARE FACILITY IN PENNSYLVANIA REPORTED VIA A FISHER AND PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE HEATED BREATHING TUBE AS PART OF THE 900PT563 AIRVO TUBE AND CHAMBER KIT WITH NEBULISER ADAPTER WAS FOUND MELTED DURING USE. THE HEALTHCARE FACILITY ALSO REPORTED THAT THE HEATED BREATHING TUBE WAS PLACED UNDER A PILLOW. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19029068 ↗MalfunctionJan 25, 2024Melted; Melted
A HEALTHCARE FACILITY IN GEORGIA VIA A FISHER AND PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE HEATED BREATHING TUBE AS PART OF THE 900PT563 AIRVO TUBE AND CHAMBER KIT WITH NEBULISER ADAPTER WAS FOUND MELTED DURING USE. THE HEALTHCARE FURTHER REPORTED THAT THE SUBJECT DEVICE WAS COVERED BY A PILLOW THAT THE PATIENT WAS LAYING ON. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18585150 ↗
Other Nebulizer (Direct Patient Interface) devices
- HUDSON RCI IPN049807Teleflex Incorporated · NEBULIZER (DIRECT PATIENT INTERFACE)62 reports
- Circulaire™ 0330Sunmed, LLC · Nebulizer (Direct Patient Interface)1 recall0 reports
- I neb 00Respironics Respiratory Drug Delivery (Uk) Ltd · NEBULIZER (DIRECT PATIENT INTERFACE)3 deaths15 reports
- VixOne 0209Westmed, Inc. · Nebulizer (Direct Patient Interface)13 reports
- HUDSON RCI IPN040620Teleflex Incorporated · NEBULIZER (DIRECT PATIENT INTERFACE)12 reports
- HUDSON RCI IPN049808Teleflex Incorporated · NEBULIZER (DIRECT PATIENT INTERFACE)6 reports
- HUDSON RCI HUD05014Medline Industries, Inc. · Nebulizer (direct patient interface)6 reports
- VixOne 0210Westmed, Inc. · Nebulizer (Direct Patient Interface)5 reports
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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