Fisher & Paykel Healthcare RT046MRecalls & reported problems
Fisher & Paykel Healthcare Limited · Non-vented Hospital Full Face Mask Standard Elbow Version - Medium · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 09420012436191), received between Jan 23, 2019 and Oct 25, 2023 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Connection Problem” (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.
Reports received per month
Most reported problems
Device problems
- Connection Problem1
- Detachment of Device or Device Component1
- Device Fell1
- Disconnection1
- Gas/Air Leak1
- Loose or Intermittent Connection1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 25, 2023Gas/Air Leak; Gas/Air Leak
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN JAPAN THAT THE ELBOW OF A RT046M NON-VENTED HOSPITAL FULL FACE MASK WAS LEAKING GAS DURING PATIENT USE. THERE WAS NO PATIENT CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18008526 ↗MalfunctionApr 6, 2021Disconnection; Connection Problem; Connection Problem
A DISTRIBUTOR IN JAPAN REPORTED THAT THE ELBOW OF THREE RT046 NON-VENTED HOSPITAL FULL FACE MASKS DISCONNECTED FROM THE SWIVEL CONNECTOR. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11625451 ↗MalfunctionJan 23, 2019Loose or Intermittent Connection; Detachment of Device or Device Component; Device Fell; Detachment of Device or Device Component
A HEALTHCARE FACILITY IN (B)(6) REPORTED TO A DISTRIBUTOR VIA A FISHER & PAYKEL HEALTHCARE (F&P) REPRESENTATIVE THAT THE SWIVEL CONNECTOR ELBOW OF A RT046 NON-VENTED HOSPITAL FULL FACE MASK WAS LOOSE AND FELL OFF DURING MASK FITTING. NO PATIENT CONSEQUENCE WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8272954 ↗
Other Ventilator, Continuous, Facility Use devices
- Trilogy Trilogy100 Ventilator, United StatesRespironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE92 deaths8,161 reports
- Trilogy Evo Trilogy Evo, USARespironics, Inc. · Ventilator, continuous, facility use6 recalls50 deaths4,393 reports
- Trilogy 100 Trilogy 100 W/ Bluetooth, USARespironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE65 deaths4,569 reports
- CARESCAPE R860Datex-Ohmeda Inc · VENTILATOR, CONTINUOUS, FACILITY USE1 recall1 death4,346 reports
- HAMILTON-C1 161001Hamilton Medical AG · Ventilator, Continuous, Facility Use2 recalls12 deaths1,849 reports
- Trilogy Trilogy O2 Ventilator JapanRespironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE7 deaths1,900 reports
- Trilogy Trilogy 202 Ventilator InternationalRespironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE11 deaths1,564 reports
- HAMILTON-C6 160021Hamilton Medical AG · Ventilator, Continuous, Facility Use5 recalls10 deaths1,175 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.
How reports and recalls are matched · Editorial policy · Report an error on this page