Fisher & Paykel Healthcare 400476Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 09420012426161), received between Jan 18, 2017 and Dec 15, 2022 — classified as 1 death, 1 malfunction.

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

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• DeathDec 15, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  ON (B)(6) 2022, A DISTRIBUTOR IN (B)(6) REPORTED THAT ON (B)(6) 2020 A PATIENT VOMITED WHILE WEARING A SIMPLUS FULL FACE MASK. THE PATIENT SUBSEQUENTLY PASSED AWAY. IT IS UNKNOWN IF THERE IS ANY CAUSAL RELATIONSHIP BETWEEN THE SUBJECT DEVICE AND THE PATIENT DEATH. FURTHER INFORMATION HAS BEEN REQUESTED FROM THE DISTRIBUTOR REGARDING THE SEQUENCE OF EVENTS AND THE MEDICAL CAUSE OF DEATH.

  Patient problems: Unspecified Heart Problem; Vomiting

  MAUDE report 15992989 ↗
• MalfunctionJan 18, 2017Device Issue; Device Issue

  A HEALTHCARE PROVIDER IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE (FPH) REPRESENTATIVE THAT THE NON-REBREATHING VALVE (NRV) FLAP OF A 400476 SIMPLUS FULL FACE MASK BROKE OFF AND ENTERED THE PATIENT'S MOUTH. THE PATIENT THEN COUGHED AND REMOVED THE BROKEN FLAP FROM HIS MOUTH. THE SUBJECT MASK IS NO LONGER IN USE BY THE PATIENT. NO FURTHER PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6262458 ↗