Companion 5 15067005Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI M766150670050), received between Aug 12, 2024 and Feb 20, 2026 — classified as 1 death, 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Use of Device Problem” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 20, 2026Use of Device Problem

  AS REPORTED TO CAIRE: PATIENT WAS SMOKING WITH OXYGEN ON IGNITING OXYGEN CANNULA. PATIENT SUSTAINED 2ND DEGREE URNS TO NARES, LEFT CHEEK, AND LIPS WHICH ARE SCABBED OVER. PATIENT HAD FLUID TO LEFT WRIST AND MIDDLE FINGER FROM THIS INCIDENT. PATIENT RECEIVED TREATMENT IN ER TO INCLUDE A TETANUS INJECTION, MORPHINE AND BACITRACIN TO NARES. PATIENT RETURNED HOME AFTER ER VISIT.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 24408161 ↗
• MalfunctionOct 24, 2024Particulates; Particulates

  THE UNIT WAS RETURNED DISPLAYING ALARM CODE AL-P08, INDICATING LOW OXYGEN. THE USER MANUAL INSTRUCTS THE USER TO NOT IGNORE THE ALARM, TO SWITCH TO THE BACKUP SOURCE OF OXYGEN, AND TO NOTIFY THE HEALTHCARE PROVIDER IMMEDIATELY. A BACKUP SOURCE OF OXYGEN IS RECOMMENDED PER USER MANUAL. THE UNIT SHOWED THE SIEVE DUST BEING EXPELLED FROM THE OUTLET BARB, SUGGESTING THAT THE UNIT WAS ALLOWED TO RUN WHILE ALARMING FOR AN EXTENDED AMOUNT OF TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20529467 ↗
• DeathAug 12, 2024Use of Device Problem; Use of Device Problem

  AS REPORTED: PATIENT FELL ASLEEP WHILE SMOKING WITH OXYGEN ON, IGNITING OXYGEN. PATIENT SUSTAINED GRADE THREE INHALATION BURNS AND ADDITIONAL PARTIAL THICKNESS BURNS TO HANDS AND FEET. SOOT NOTED THROUGH THE MOUTH AND NOSE, AND BILATERAL CORNEAL ABRASIONS. PATIENT TAKEN TO TRANSFERRED TO ORLANDO REGIONAL MEDICAL CENTER BURN UNIT. PATIENT IS CURRENTLY INTUBATED WITH VENTILATOR SUPPORT. UPDATED 17 JULY: PATIENT DEATH DATE (B)(6) 2024.

  Patient problems: Burn(s)

  MAUDE report 19964481 ↗