Fisher & Paykel Healthcare OPT842Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 09420012432117), received between Apr 8, 2020 and Oct 14, 2021 — classified as 7 malfunctions.

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

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 14, 2021Break; Break

  A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN (B)(4), THAT THE CONNECTOR HOOKS OF TWO OPT842 OPTIFLOW ADULT NASAL CANNULAS WERE FOUND DAMAGED DURING PATIENT USE. THERE WERE NO REPORTED PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12637266 ↗
• MalfunctionSep 8, 2021Break; Detachment of Device or Device Component; Detachment of Device or Device Component

  A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA THAT AN OPT842 OPTIFLOW ADULT NASAL CANNULA WAS FOUND DAMAGED DURING USE. THE HEALTHCARE FACILITY FURTHER REPORTED THAT THE PATIENT PULLED THE SUBJECT OPT842 DEVICE. THERE WERE NO REPORTED PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12437332 ↗
• MalfunctionAug 5, 2021Break; Break

  A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN (B)(6) THAT THE OPT842 OPTIFLOW ADULT NASAL CANNULA BROKE DURING PATIENT USE. IT WAS FURTHER REPORTED THAT THE DAMAGE WAS CAUSED BY THE PATIENT PULLING AT THE TUBING OF THE SUBJECT OPT842. THERE WERE NO REPORTED PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12285684 ↗
• MalfunctionJul 1, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN (B)(6) THAT THE OPT842 NASAL CANNULA WAS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12104667 ↗
• MalfunctionMay 5, 2021Break; Break

  A HEALTHCARE FACILITY IN (B)(6) REPORTED ON BEHALF OF A DISTRIBUTOR VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE OPT842 OPTIFLOW ADULT NASAL CANNULA CONNECTOR WAS DAMAGED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11780340 ↗
• MalfunctionNov 11, 2020Break; Break

  A DISTRIBUTOR IN (B)(4) REPORTED ON BEHALF OF A HEALTHCARE FACILITY, VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THE OPT844 NASAL CANNULA WAS DAMAGED DURING PATIENT USE. THERE WAS NO REPORTED PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10826793 ↗
• MalfunctionApr 8, 2020Break; Device Handling Problem; Device Handling Problem

  A DISTRIBUTOR IN COLOMBIA REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE TUBING OF A OPT842 NASAL CANNULA WAS DAMAGED. THE DAMAGE WAS FOUND OUT OF BOX. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9936487 ↗