Fisher & Paykel Healthcare BC161-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 09420012412430), received between Nov 8, 2020 and Nov 20, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (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.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 20, 2025Unintended Movement; Unintended Movement

  A HEALTHCARE FACILITY IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE CPAP PROBE OF THE BUBBLE CPAP GENERATOR SLIPPED OUT OF POSITION. HOWEVER, THE UNIT WAS FURTHER INSPECTED BY THE HEALTHCARE FACILITY AND NO ISSUES WERE IDENTIFIED WITH THE DEVICE ITSELF. THE BUBBLE CPAP GENERATOR IS PART OF THE BC161-10, BUBBLE CPAP SYSTEM KIT (SUBJECT DEVICE). THERE WAS NO REPORTED PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23613135 ↗
• MalfunctionNov 6, 2025Unintended Movement; Unintended Movement

  A HEALTHCARE FACILITY IN TEXAS REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE CPAP PROBE OF THE THREE BUBBLE CPAP GENERATORS WAS SLIPPING DOWN OUT OF POSITION. THE BUBBLE CPAP GENERATOR IS PART OF THE BC161-10, BUBBLE CPAP SYSTEM KIT (SUBJECT DEVICE). THERE WAS NO REPORTED PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23489973 ↗
• MalfunctionOct 5, 2025Connection Problem; Connection Problem

  A HEALTHCARE FACILITY IN GEORGIA REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT A TEMPERATURE/FLOW PROBE WAS LOOSE AND "FALLING OUT" FROM THE TEMPERATURE PROBE PORT OF A BC161-10 BUBBLE CPAP SYSTEM BEFORE PATIENT USE. THERE WAS NO REPORTED PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23218949 ↗
• MalfunctionJun 8, 2025Connection Problem; Connection Problem

  A HEALTHCARE FACILITY IN ALASKA REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT TEMPERATURE/FLOW PROBES WERE "FALLING OFF" FROM A TEMPERATURE PROBE PORT OF A BC161-10 BUBBLE CPAP SYSTEM. THERE WAS NO REPORTED PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22164756 ↗
• MalfunctionMar 19, 2025Connection Problem; Device Dislodged or Dislocated; Connection Problem; Device Dislodged or Dislocated

  A HEALTHCARE FACILITY REPORTED VIA A FISHER & PAYKEL (F&P) HEALTHCARE FIELD REPRESENTATIVE, THAT A TEMPERATURE PROBE WAS OBSERVED TO BE LOOSE AND DISLODGING AT THE PATIENT-END TEMPERATURE PROBE PORT OF AN INFANT BREATHING CIRCUIT DURING PATIENT USE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21649597 ↗
• MalfunctionMar 19, 2025Connection Problem; Device Dislodged or Dislocated; Connection Problem; Device Dislodged or Dislocated

  A HEALTHCARE FACILITY REPORTED VIA A FISHER & PAYKEL (F&P) HEALTHCARE FIELD REPRESENTATIVE, THAT THE TEMPERATURE PROBE WAS OBSERVED TO BE LOOSE AND DISLODGING AT THE PATIENT-END TEMPERATURE PROBE PORT OF TWO INFANT BREATHING CIRCUITS DURING SET UP AND PRIOR TO PATIENT USE. THERE WAS NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21649596 ↗
• MalfunctionSep 26, 2024Unintended Movement; Unintended Movement

  A HEALTHCARE FACILITY IN TEXAS REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE PEEP GAUGE OF THE BC161 BUBBLE CPAP SYSTEM WAS NOT STAYING IN PLACE DURING PATIENT USE. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20315753 ↗
• MalfunctionJun 26, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  A HEALTHCARE FACILITY IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE BC161 BUBBLE CPAP SYSTEM HAD CUTS IN THE CIRCUITS. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19620688 ↗
• MalfunctionJun 19, 2023Unintended Movement; Unintended Movement

  A DISTRIBUTOR IN INDIA 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 BC161 BUBBLE CPAP SYSTEM KIT. THERE WAS NO REPORTED PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17159781 ↗
• MalfunctionNov 8, 2020Leak/Splash; Leak/Splash

  A DISTRIBUTOR IN (B)(4) REPORTED ON BEHALF OF A HEALTHCARE FACILITY VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT A MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER BASE WAS LEAKING WATER DURING USE. THERE WAS NO REPORTED PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10806672 ↗