Fisher & Paykel Healthcare BC306-05Recalls & reported problems
Fisher & Paykel Healthcare Limited · Infant Bonnet · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 09420012432513), received between Dec 14, 2022 and Jan 6, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break1
- Detachment of Device or Device Component1
Patient problems
- Low Oxygen Saturation1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 6, 2025Break; Break
A HEALTHCARE FACILITY IN OHIO REPORTED VIA A FISHER & PAYKEL HEALTHCARE FIELD REPRESENTATIVE THAT THE FRONT STRAP ON A BC306-05 INFANT BONNET WAS GETTING PEELED OFF. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21088264 ↗MalfunctionDec 14, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
A DISTRIBUTOR IN COLOMBIA REPORTED ON BEHALF OF A HEALTHCARE FACILITY VIA A FISHER AND PAYKEL (F&P) HEALTHCARE REPRESENTATIVE THAT A CONNECTOR OF A BC306 FLEXITRUNK NASAL CPAP BONNET WAS BROKEN. IT WAS FURTHER REPORTED THAT THE MASK WAS DETACHED AS THE RESULT OF THE CONNECTOR BEING BROKEN. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: Low Oxygen Saturation
MAUDE report 15983867 ↗
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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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