F&P FlexiTrunk BC801-10Recalls & reported problems
Fisher & Paykel Healthcare Limited · Infant Nasal Mask · Class 1
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 09420012432681), received between Sep 18, 2024 and Apr 6, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Gas/Air Leak” (3 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Gas/Air Leak3
- Failure to Seal1
- Insufficient Device Problem Information1
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 6, 2025Gas/Air Leak; Gas/Air Leak
A HEALTHCARE FACILITY IN OHIO HAS REPORTED THAT THE TWO UNITS OF BC801-10 INFANT NASAL MASK MEDIUM BCPAP COULD NOT HOLD A SEAL AND LEAKS. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21782727 ↗MalfunctionNov 28, 2024Leak/Splash; Failure to Seal; Leak/Splash; Failure to Seal
A HEALTHCARE FACILITY IN OHIO REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT TWO BC801 INFANT NASAL MASK MEDIUM BCPAP WERE NOT CREATING A SEAL DURING PATIENT USE. THERE WERE NO REPORTED PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20808224 ↗MalfunctionNov 27, 2024Gas/Air Leak; Gas/Air Leak
A HEALTHCARE FACILITY IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) REPRESENTATIVE THAT THE BC801-10 INFANT NASAL MASK MEDIUM BCPAP COULD NOT HOLD A SEAL AND LEAKS. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20803005 ↗MalfunctionSep 18, 2024Gas/Air Leak; Insufficient Device Problem Information; Gas/Air Leak; Insufficient Device Problem Information
A HEALTHCARE FACILITY IN SAN DIEGO HAS REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) REPRESENTATIVE THAT THE BC801-10 INFANT NASAL MASK MEDIUM BCPAP COULD NOT HOLD A SEAL AND LEAKS. THERE WAS NO REPORTED PATIENT CONSEQUENCE AS THE MASK WAS REPLACED IMMEDIATELY AFTER NOTICING THE REPORTED FAILURE. THE HEALTHCARE FACILITY FURTHER REPORTED THAT THEY CURRENTLY HAVE NINETY UNUSED MASKS FROM TWO DIFFERENT BATCHES. FISHER & PAYKEL HEALTHCARE (F&P) HAS REQUESTED THE HEALTHCARE FACILITY TO RETURN ALL THE MASKS FOR AN INVESTIGATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20243278 ↗
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- Disposable Face Mask 000252956Ambu A/S · MASK, OXYGEN4 reports
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- AcuCare 60786Resmed Pty Ltd · Mask, Oxygen2 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.