FISHER & PAYKEL HEALTHCARE RT040MRecalls & reported problems
Fisher & Paykel Healthcare Limited · Vented Mask with Anti-Asphyxiation Valve · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 09420012429834), received between Jan 21, 2021 and Oct 18, 2023 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Break” (4 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
- Break4
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 18, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA REPORTED THAT THE SEAL OF A RT040M VENTED HOSPITAL FULL FACE MASK DISCONNECTED FROM THE MASK FRAME DURING PATIENT USE. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17962505 ↗MalfunctionOct 3, 2022Break; Break
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA THAT THE HEADGEAR STRAP OF A RT040M VENTED HOSPITAL FULL FACE MASK WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15534507 ↗MalfunctionJul 7, 2021Break; Break
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN (B)(6) THAT THE HEADGEAR STRAP OF A RT040M VENTED HOSPITAL FULL FACE MASK WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12126056 ↗MalfunctionMay 13, 2021Break
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA THAT THE HEADGEAR STRAP OF TWO RT040M VENTED HOSPITAL FULL FACE MASK WERE BROKEN. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11823622 ↗MalfunctionJan 21, 2021Break
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA, VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE HEADGEAR STRAP OF A RT040M VENTED HOSPITAL FULL FACE MASK WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11210765 ↗
Other Ventilator, Continuous, Minimal Ventilatory Support,Facility Use devices
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- PHILIPS 1053613Respironics California, Inc. · Ventilator, continuous, minimal ventilatory support, facility use2 recalls1 death161 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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