Vital Signs™ 54039VSRecalls & reported problems
Airlife · Vital Signs™ baby safe flow-inflating resuscitation · Class 2
All models of Vital Signs (48)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10889483585825), received between Apr 3, 2026 and Apr 3, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Gas/Air Leak” (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.
Reports received per month
Most reported problems
Device problems
- Gas/Air Leak1
Patient problems
- Low Oxygen Saturation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 3, 2026Gas/Air Leak
IT WAS REPORTED THAT ON (B)(6) 2026, WHILE PREPARING TO TRANSFER THE PATIENT TO THE NICU, A FLOW INFLATING RESUSCITATION (FIR) DEVICE WAS CONNECTED TO THE OXYGEN TANK. UPON ACTIVATION, THE PATIENT BEGAN TO DESATURATE. THE ANESTHESIOLOGIST OBSERVED THAT THE DEVICE WAS LEAKING OXYGEN THROUGH A HOLE, RESULTING IN INEFFECTIVE OXYGEN DELIVERY. THE ANESTHESIOLOGIST PROMPTLY RECONNECTED THE ANESTHESIA MACHINE, PROVIDED APPROPRIATE OXYGEN, AND STABILIZED THE PATIENT. A NEW FIR DEVICE WAS THEN OBTAINED AND CONNECTED, ALLOWING THE TEAM TO PROCEED WITH THE TRANSFER. NO SERIOUS HARM OR INJURY WAS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Low Oxygen Saturation
MAUDE report 24776337 ↗
Other Ventilator, Non-Continuous (Respirator) devices
- REMstar System One 60 Series REMstar Auto A-Flex, w/Humid System One 60 Series USRespironics, Inc. · VENTILATOR, NON-CONTINUOUS (RESPIRATOR)117 deaths10,075 reports
- DreamStation DreamStation Auto BiPAP w/Humidifier, w/Cell, USRespironics, Inc. · VENTILATOR, NON-CONTINUOUS (RESPIRATOR)106 deaths5,937 reports
- DreamStation DreamStation Auto CPAP with Humidifier, USRespironics, Inc. · VENTILATOR, NON-CONTINUOUS (RESPIRATOR)44 deaths5,793 reports
- REMstar System One 60 Series REMstar Auto A-Flex System One 60 Series USRespironics, Inc. · VENTILATOR, NON-CONTINUOUS (RESPIRATOR)64 deaths5,138 reports
- REMstar System One 60 Series REMstar Pro C-Flex+, w/Humid System One 60 Series USRespironics, Inc. · VENTILATOR, NON-CONTINUOUS (RESPIRATOR)65 deaths4,520 reports
- REMstar System One 60 Series REMstar Auto A-Flex w/HT Humid System One 60 Series, USRespironics, Inc. · VENTILATOR, NON-CONTINUOUS (RESPIRATOR)43 deaths4,149 reports
- DreamStation DreamStation Auto CPAP w/Humid w/Heated Tube, USRespironics, Inc. · VENTILATOR, NON-CONTINUOUS (RESPIRATOR)30 deaths3,981 reports
- DreamStation DreamStation Auto CPAP w/Humidifier, w/Cell, USRespironics, Inc. · VENTILATOR, NON-CONTINUOUS (RESPIRATOR)86 deaths3,516 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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