FISHER & PAYKEL HEALTHCARE RT041MRecalls & reported problems
Fisher & Paykel Healthcare Limited · Non Vented Mask · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 09420012429865), received between Mar 17, 2022 and Dec 21, 2023 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component6
- Disconnection2
Patient problems
- No Clinical Signs, Symptoms or Conditions6
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 21, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
A HEALTHCARE FACILITY IN GERMANY REPORTED VIA A FISHER AND PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE SEAL OF A RT041M NON-VENTED HOSPITAL FULL FACE MASK DISCONNECTED FROM THE MASK FRAME. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18379807 ↗MalfunctionMay 23, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
A HEALTHCARE FACILITY IN FRANCE REPORTED THAT THE SEAL OF A RT041M NON-VENTED HOSPITAL FULL FACE MASK DISCONNECTED FROM THE MASK FRAME. THERE WAS NO REPORTED PATIENT CONSEQUENCE. FURTHER INFORMATION WITH REGARDS TO THE REPORTED EVENT WAS REQUESTED FROM THE HEALTHCARE FACILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16989977 ↗MalfunctionJan 15, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
A HEALTHCARE FACILITY IN GERMANY REPORTED VIA A FISHER AND PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE, THAT THE SEAL OF A RT041M FULL FACE MASK DISCONNECTED FROM THE MASK FRAME. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16172193 ↗MalfunctionAug 14, 2022Disconnection; Detachment of Device or Device Component; Detachment of Device or Device Component
A DISTRIBUTOR REPORTED ON BEHALF OF HEALTHCARE FACILITY IN CHINA THAT THE SEAL OF A RT041 FULL FACE MASK DISCONNECTED FROM THE MASK FRAME. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15223043 ↗MalfunctionApr 13, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN (B)(4) THAT THE SEAL OF A RT041 NON-VENTED HOSPITAL FULL FACE MASK WAS SEPARATED FROM THE MASK BASE DURING USE. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14107398 ↗MalfunctionMar 17, 2022Disconnection; Detachment of Device or Device Component; Detachment of Device or Device Component
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT THE SEAL OF A RT041 FULL FACE MASK DISCONNECTED FROM THE MASK FRAME. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13794893 ↗
Other Ventilator, Continuous, Facility Use devices
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- 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.
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