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F&P Optiflow+ OPT944ERecalls & reported problems

Fisher & Paykel Healthcare Limited · Optiflow Nasal Cannula Medium (Single) · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 09420012429735), received between Jan 17, 2022 and Jan 17, 2022 — classified as 1 malfunction.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Break1
  • Material Split, Cut or Torn1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJan 17, 2022Material Split, Cut or Torn; Break; Material Split, Cut or Torn

    A DISTRIBUTOR IN (B)(4) REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT AN OPT944 OPTIFLOW + ADULT NASAL CANNULA WAS FOUND DAMAGED DURING USE. THERE WAS NO REPORTED PATIENT CONSEQUENCE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13269915 ↗

Other Humidifier, Respiratory Gas, (Direct Patient Interface) devices

All Humidifier, Respiratory Gas, (Direct Patient Interface) devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.