N/A 1600-7Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00607411100253), received between Oct 20, 2023 and Nov 6, 2025 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fire” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryNov 6, 2025Partial Blockage; Obstruction of Flow; Partial Blockage; Obstruction of Flow

  IT WAS REPORTED THAT THE TUBING OF WHAT THEY RECEIVED IS EXPIRED BECAUSE IT'S DRIED OUT AND IT RESTRICTED THE OXYGEN FLOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23493536 ↗
• InjuryJan 22, 2025Fire; Patient Device Interaction Problem; Fire; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT WAS SMOKING DURING INHALATION AND BURNED HIMSELF. ONE INCIDENT WAS REPORTED FOR THIS DEVICES. IT WAS STATEED THAT " ON (B)(6) 2024 AROUND 9 PM PATIENT INHALED OXYGEN PRODUCED BY PHILIPS -EVERFLO. PATIENT SMOKED DURING INHALATION AND BURNED HIMSELF. ACCORDING TO THE INFORMATION HE HAS 2ND DEGREE BURNS IN THE HEAD AND UPPER BODY. HIS CONDITION WAS STABILIZED, AND HE WAS HOSPITALIZED IN THE HOSPITAL IN PILSEN. ACCORDING TO THE INFORMATION, THE FIRE BRIGADE WAS PRESENT AT THE SCENE. CHIEF PHYSICIAN REFERRED THE PATIENT AND AGREED WITH HOMECARE SERVICE MANAGER TO STOP THE OXYGEN TREATMENT."

  Patient problems: Burn(s); Partial thickness (Second Degree) Burn

  MAUDE report 21211811 ↗
• MalfunctionSep 4, 2024Fire; Off-Label Use; Fire; Off-Label Use

  IT WAS REPORTED, THE PATIENT LIT A CANDLE NEXT TO HER OXYGEN GOGGLES, DESPITE THE TRAINING SHE RECEIVED WHEN THE DEVICE WAS INSTALLED. AS A RESULT, THE OXYGEN CONCENTRATOR AND ALL THE HOSES LEADING TO THE DEVICE WERE BURNED AND DAMAGED. THE PATIENT WAS UNHARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20141066 ↗
• InjuryOct 20, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  WHEN HIS OXYGEN WAS INSTALLED, HE WAS PROVIDED WITH GLASSES WHICH CAUSED HIM AN ALLERGY, WITH ITCHY ECZEMA-LIKE LESIONS AT THE LEVEL OF THE TUBING (UNDER THE CHIN, AND IN THE NECK). NO CHANGE IN COSMETIC PRODUCT HABITS THAT COULD EXPLAIN AN ALLERGY. NO MISUSE OF THE GLASSES. THE PATIENT SAW THE LESIONS DISAPPEAR AS SOON AS SHE CHANGED HER GLASSES MODEL.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 17978299 ↗
• MalfunctionOct 20, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  "THE NASAL TIP BECAME SEPARATED FROM THE TUBES DURING THE NIGHT. THE TELESCOPE WAS INSTALLED NEW ON SUNDAY EVENING (B)(6) BEFORE BEDTIME AND THE INCIDENT OCCURRED ON THE NIGHT OF JUNE (B)(6). THE BATCH NUMBER HAS NOT BEEN PRESERVED. NO CLINICAL CONSEQUENCES."

  Patient problems: Unspecified Respiratory Problem

  MAUDE report 17978264 ↗