Provox Life Night HME 8262Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07331791014512), received between Feb 22, 2021 and Feb 22, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Use of Device Problem” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 22, 2021Use of Device Problem; Use of Device Problem

  AN (B)(6) MAN ((B)(6)) WAS BROUGHT TO THE HOSPITAL DUE TO RESPIRATORY PROBLEMS AFTER A VERY SEVERE COUGHING FIT. FIBERSCOPE VERIFIES A NIGHT HME OCCLUDING THE RIGHT MAIN BRONCHUS. IN GA THE HME HAD BEEN TAKEN UP WITH SOME DAMAGE TO THE MUCOUS MEMBRAN. ANTIBIOTIC MEDICINE WAS GIVEN PER AND POST OPERATION. THE MAN WAS BACK HOME AFTER 12 HOURS. AS THE USER RECALLS, THE HME WAS VERY SLIPPERY WITH MUCUS. AFTER A HUGE COUGH THE USER TRIED TO REATTACH THE HME, AND IT GOT PUSHED OR SUCKED INTO THE TRACHEA. DESCRIPTION OF THE PRODUCT: PROVOX LIFE HMES ARE SINGLE-USE DEVICES FOR PULMONARY REHABILITATION. THEY COME IN DIFFERENT LEVELS OF HUMIDIFICATION, BREATHING RESISTANCE AND FILTRATION THAT MAKES THEM SUITABLE FOR DIFFERENT SITUATIONS. THE DIFFERENT PROVOX LIFE HMES ARE: HOME: WHEN TAKING IT EASY, GO: WHEN YOU ARE OUT AND ABOUT, ENERGY: WHEN PHYSICALLY ACTIVE, PROTECT: WHEN YOU NEED PROTECTION FROM BACTERIA, VIRUS, DUST AND POLLEN, NIGHT: WHEN SLEEPING. INTENDED USE: PROVOX LIFE HMES ARE SINGLE USE HEAT- AND MOISTURE EXCHANGERS FOR PATIENTS BREATHING THROUGH A TRACHEOSTOMA.

  Patient problems: Foreign Body Reaction

  MAUDE report 11357349 ↗