AirLife™ 001350Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10190752116252), received between Oct 24, 2022 and Nov 7, 2025 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (4 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 7, 2025Connection Problem; Connection Problem

  IT WAS REPORTED THAT A MEDICAL DEVICE INCIDENT (MDI) WITH HARM OR WITH THE POTENTIAL FOR SERIOUS HARM/DEATH HAS BEEN REPORTED. - CARDINAL HEALTH CANADA PRODUCT COMPLAINT (B)(4). UNKNOWN PATIENT ARRIVED VIA EMS IN CRITICAL CONDITION FOLLOWING A SEVERE BURN INJURY. INTERMITTENT SPO2 CHALLENGES INCLUDING DURING INTUBATION WITH MANUAL VENTILATION VIA MASK, AND MANUAL VENTILATION VIA ETT. SPO2 54% AT THE LOWEST. PATIENT REQUIRING CONTINUOUS HIGH FLOW O2 THERAPY (15LPM VIA NON-REBREATHER, FOLLOWED BY CONTINUOUS MANUAL VENTILATION VIA MASK THEN ETT FOR 45 MINUTES, THEN EVENTUALLY 100% ON VENTILATOR, DUE TO PATIENT'S INJURIES. DURING THIS TIME ON 3 OCCASIONS, RRTS NOTICED BAGGER WAS DISCONNECTED FROM O2 TUBING ON THE BAGGER SIDE.

  Patient problems: Low Oxygen Saturation

  MAUDE report 23501763 ↗
• InjuryNov 7, 2025Connection Problem; Connection Problem

  IT WAS REPORTED THAT A MEDICAL DEVICE INCIDENT (MDI) WITH HARM OR WITH THE POTENTIAL FOR SERIOUS HARM/DEATH HAS BEEN REPORTED. - CARDINAL HEALTH CANADA PRODUCT COMPLAINT PCS251008IOELIY . UNKNOWN PATIENT ARRIVED VIA EMS IN CRITICAL CONDITION FOLLOWING A SEVERE BURN INJURY. INTERMITTENT SPO2 CHALLENGES INCLUDING DURING INTUBATION WITH MANUAL VENTILATION VIA MASK, AND MANUAL VENTILATION VIA ETT. SPO2 54% AT THE LOWEST. PATIENT REQUIRING CONTINUOUS HIGH FLOW O2 THERAPY (15LPM VIA NON-REBREATHER, FOLLOWED BY CONTINUOUS MANUAL VENTILATION VIA MASK THEN ETT FOR 45 MINUTES, THEN EVENTUALLY 100% ON VENTILATOR, DUE TO PATIENT'S INJURIES. DURING THIS TIME ON 3 OCCASIONS, RRTS NOTICED BAGGER WAS DISCONNECTED FROM O2 TUBING ON THE BAGGER SIDE. .

  Patient problems: Low Oxygen Saturation

  MAUDE report 23501762 ↗
• InjuryNov 7, 2025Connection Problem; Connection Problem

  IT WAS REPORTED THAT A MEDICAL DEVICE INCIDENT (MDI) WITH HARM OR WITH THE POTENTIAL FOR SERIOUS HARM/DEATH HAS BEEN REPORTED. - CARDINAL HEALTH CANADA PRODUCT COMPLAINT (B)(4). UNKNOWN PATIENT ARRIVED VIA EMS IN CRITICAL CONDITION FOLLOWING A SEVERE BURN INJURY. INTERMITTENT SPO2 CHALLENGES INCLUDING DURING INTUBATION WITH MANUAL VENTILATION VIA MASK, AND MANUAL VENTILATION VIA ETT. SPO2 54% AT THE LOWEST. PATIENT REQUIRING CONTINUOUS HIGH FLOW O2 THERAPY (15LPM VIA NON-REBREATHER, FOLLOWED BY CONTINUOUS MANUAL VENTILATION VIA MASK THEN ETT FOR 45 MINUTES, THEN EVENTUALLY 100% ON VENTILATOR, DUE TO PATIENT'S INJURIES. DURING THIS TIME ON 3 OCCASIONS, RRTS NOTICED BAGGER WAS DISCONNECTED FROM O2 TUBING ON THE BAGGER SIDE.

  Patient problems: Low Oxygen Saturation

  MAUDE report 23501759 ↗
• MalfunctionJul 18, 2025Connection Problem; Connection Problem

  IT WAS REPORTED: LOOSE CONNECTION BETWEEN THE TUBING AND THE EQUIPMENT; IT LITERALLY FALLS OFF WITH THE SLIGHTEST BIT OF MOTION THE MATERIAL FEELS STIFF. NO REPORTED INJURY. WHILE NO HARM OR INJURY WAS REPORTED, ANY COMPONENT THAT IS PART OF THE VENT CIRCUIT (FLEX CONNECTOR, DOUBLE SWIVEL ELBOW, Y-ADAPTER, T-PIECE, ETT ADAPTER, ETC.) BREAKS, CRACKS, OR LEAKS AFTER THE VENT CIRCUIT HAS BEEN ESTABLISHED ON THE PATIENT COULD CAUSE A DELAY IN CARE AND OR LEAD TO A SERIOUS INJURY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22549423 ↗
• MalfunctionOct 24, 2022Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE TUBING OXYGEN 7FT CRUSH RESISTANT 50/CS HAD AN ISSUE WITH THE NEBULIZERS THAT DO NOT PRODUCE MIST AND SOME JUST BUBBLES. AT THIS TIME, THERE IS NO INFORMATION REGARDING PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15664094 ↗