Portex 0552Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 50351688600118), received between Jun 22, 2018 and Jun 22, 2018 — classified as 1 death.

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

Recent adverse event reports

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

• DeathJun 22, 2018Break; Gas Output Problem; Break; Gas Output Problem

  IT WAS REPORTED THAT A PATIENT WAS ADMITTED TO HOSPITAL CARE AND PATIENT LATER EXPIRED. THE DEVICE A PORTEX® O2 HUMIDIFIER; STERILE WATER FOR INHALATION USP BOTTLE WAS IN THE PATIENT'S HOME FOR "FIRST AID" USE. IT WAS FURTHER REPORTED THAT "ON (B)(6) 2018 THE SON-IN-LAW WAS CALLED BY THE NURSE OF HIS MOTHER-IN-LAW, BECAUSE SHE SUFFERED A HEART ATTACK. WHEN HE ARRIVED AT HER, SHE BREATHED HEAVILY. HE WANTED TO SUPPLY HER WITH OXYGEN [USING THE DEVICE], BUT THE OXYGEN DID NOT COME OUT OF THE OXYGEN GOGGLES, BUT CAME OFF AT THE COUPLING PIECE (ADAPTER) OF THE HUMIDIFIER BOTTLE BECAUSE IT WAS BROKEN. THE HOSPITALIZATION FOLLOWING THE EVENT WILL AT LEAST MAKE THE ASSESSMENT A SERIOUS EVENT, REGARDLESS OF WHETHER THE HEART ATTACK ITSELF OR THE LACK OF OXYGEN WAS THE REASON." THE ORIGINAL COMPLAINT INFORMATION RECEIVED WAS THAT THE PATIENT'S SUBSEQUENT DEATH WAS "BEYOND DOUBT UNRELATED TO THE EVENT".

  Patient problems: Death; Hypoxia; Myocardial Infarction

  MAUDE report 7630832 ↗