Fisher & Paykel Healthcare BC153-10Recalls & reported problems
Fisher & Paykel Healthcare Limited · BC153 Bubble CPAP System · 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 09420012412379), received between Sep 13, 2023 and Nov 27, 2023 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Unintended Movement” (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
- Unintended Movement6
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.
MalfunctionNov 27, 2023Unintended Movement; Unintended Movement
A HEALTHCARE FACILITY IN WISCONSIN REPORTED, VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE, THAT THE CPAP PROBE OF A BUBBLE CPAP GENERATOR WAS LOOSE. THE BUBBLE CPAP GENERATOR IS PART OF THE BC153 BUBBLE CPAP SYSTEM KIT. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18213706 ↗MalfunctionSep 13, 2023Unintended Movement; Unintended Movement
A HEALTHCARE FACILITY IN (B)(6) REPORTED, VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE, THAT THE CPAP PROBE OF A BUBBLE CPAP GENERATOR WAS LOOSE. THE BUBBLE CPAP GENERATOR IS PART OF THE BC153 BUBBLE CPAP SYSTEM KIT. THERE WAS NO PATIENT INVOLVEMENT AS THE ISSUE WAS FOUND WHILST THE DEVICE WAS NOT IN USE ON A PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17741949 ↗MalfunctionSep 13, 2023Unintended Movement; Unintended Movement
A HEALTHCARE FACILITY IN (B)(6) REPORTED, VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE, THAT THE CPAP PROBE OF A BUBBLE CPAP GENERATOR WAS LOOSE. THE BUBBLE CPAP GENERATOR IS PART OF THE BC153 BUBBLE CPAP SYSTEM KIT. THERE WAS NO PATIENT INVOLVEMENT AS THE ISSUE WAS FOUND WHILST THE DEVICE WAS NOT IN USE ON A PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17741948 ↗MalfunctionSep 13, 2023Unintended Movement; Unintended Movement
A HEALTHCARE FACILITY IN CALIFORNIA REPORTED, VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE, THAT THE CPAP PROBE OF A BUBBLE CPAP GENERATOR WAS LOOSE. THE BUBBLE CPAP GENERATOR IS PART OF THE BC153 BUBBLE CPAP SYSTEM KIT. THERE WAS NO PATIENT INVOLVEMENT AS THE ISSUE WAS FOUND WHILST THE DEVICE WAS NOT IN USE ON A PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17741945 ↗MalfunctionSep 13, 2023Unintended Movement; Unintended Movement
A HEALTHCARE FACILITY IN (B)(6) REPORTED, VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE, THAT THE CPAP PROBE OF A BUBBLE CPAP GENERATOR WAS LOOSE. THE BUBBLE CPAP GENERATOR IS PART OF THE BC153 BUBBLE CPAP SYSTEM KIT. THERE WAS NO PATIENT INVOLVEMENT AS THE ISSUE WAS FOUND WHILST THE DEVICE WAS NOT IN USE ON A PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17741944 ↗MalfunctionSep 13, 2023Unintended Movement; Unintended Movement
A HEALTHCARE FACILITY IN CALIFORNIA REPORTED, VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE, THAT THE CPAP PROBE OF A BUBBLE CPAP GENERATOR WAS LOOSE. THE BUBBLE CPAP GENERATOR IS PART OF THE BC153 BUBBLE CPAP SYSTEM KIT. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17741922 ↗
Other Ventilator, Non-Continuous (Respirator) devices
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- DreamStation DreamStation Auto CPAP with Humidifier, USRespironics, Inc. · VENTILATOR, NON-CONTINUOUS (RESPIRATOR)44 deaths5,793 reports
- REMstar System One 60 Series REMstar Auto A-Flex System One 60 Series USRespironics, Inc. · VENTILATOR, NON-CONTINUOUS (RESPIRATOR)64 deaths5,138 reports
- REMstar System One 60 Series REMstar Pro C-Flex+, w/Humid System One 60 Series USRespironics, Inc. · VENTILATOR, NON-CONTINUOUS (RESPIRATOR)65 deaths4,520 reports
- REMstar System One 60 Series REMstar Auto A-Flex w/HT Humid System One 60 Series, USRespironics, Inc. · VENTILATOR, NON-CONTINUOUS (RESPIRATOR)43 deaths4,149 reports
- DreamStation DreamStation Auto CPAP w/Humid w/Heated Tube, USRespironics, Inc. · VENTILATOR, NON-CONTINUOUS (RESPIRATOR)30 deaths3,981 reports
- DreamStation DreamStation Auto CPAP w/Humidifier, w/Cell, USRespironics, Inc. · VENTILATOR, NON-CONTINUOUS (RESPIRATOR)86 deaths3,516 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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