Fisher & Paykel Healthcare RT047MRecalls & reported problems

Fisher & Paykel Healthcare Limited · Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version- Medium · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 09420012455338), received between Dec 22, 2020 and Dec 22, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (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

Loose or Intermittent Connection1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionDec 22, 2020Loose or Intermittent Connection
A HEALTHCARE FACILITY IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE RT047 VENTED HOSPITAL FULL FACE MASK CAME LOOSE DURING PATIENT USE. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11060209 ↗

Device details

UDI-DI	`09420012455338`
Brand	Fisher & Paykel Healthcare
Model	RT047M
Company	Fisher & Paykel Healthcare Limited
Product code	MNT · Ventilator, Continuous, Minimal Ventilatory Support, Facility Use
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Mar 18, 2026

Device type (GMDN): CPAP/BPAP face mask, single-use

A non-sterile, flexible, form-shaped device designed to be placed over a user's nose and mouth to interface with a continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BPAP) unit to provide the respiratory tract with direct ambient air, or medical oxygen (O2) and air, at a higher pressure than ambient air for noninvasive positive pressure ventilation (NPPV). It is typically made of plastic/silicone materials that create an airtight seal around the nose and mouth. It is available in various designs and sizes and stabilized with a headstrap. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.

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All Ventilator, Continuous, Minimal Ventilatory Support, Facility Use devices →

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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