Attachment, Breathing, Positive End Expiratory Pressure
FDA adverse event reports and recall history for attachment, breathing, positive end expiratory pressure (product code BYE), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 253
- Deaths
- 34
- Injuries
- 77
- Malfunctions
- 123
Reports per year
Source: FDA adverse event reports by year received, 2011–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2015-12-24TerminatedNonconforming Material/Component
Airways Development LLC WaterPAP Positive Airway Pressure Device Reference #WP-7700.
Airways Development LLC has received a complaint about a canister leaking from WaterPAP Lot 8605A. During a review with their supplier it could not be determined if this was an isolated incident or if the whole lot is impacted.
- 2008-07-16TerminatedNonconforming Material/Component
Smiths Medical FLO2 Emergency Non-rebreather High Flow O2 System; Positive end expiratory pressure breathing attachment; Reference Number: P60000; Smiths Medical, Rockland, MA 02370.
Incorrect Oxygen Level: Device may not provide expected oxygen concentration or the expected flow rate due to incorrectly molded part. Patient will not receive proper amounts of air/oxygen when in need.
- 2008-07-16TerminatedNonconforming Material/Component
Smiths Medical Oxy-PEEP High Flow O2 with PEEP; Positive end expiratory pressure breathing attachment; Reference Number: P63000; Smiths Medical, Rockland, MA 02370.
Incorrect Oxygen Level: Device may not provide expected oxygen concentration or the expected flow rate due to incorrectly molded part. Patient will not receive proper amounts of air/oxygen when in need.
- 2007-12-22TerminatedProcess design
Ambu, Positive End Expiratory Pressure (PEEP) Valves, PEEP Valve 10, 30 mm, REF 000 137 000, Manufacturer: Ambu International A/S, DK2750 Ballerup USA: Ambu Inc. (Ambu USA) Linthicum, MD 21090-1356 USA, Made in Denmark
Lower pressure than expected: Medical device for respiratory care may leak and not register accurate flow settings that affect patient respiration.
- 2007-12-22TerminatedProcess design
Ambu, Positive End Expiratory Pressure (PEEP) Valves, PEEP Valve 10, 22/18 mm, REF 000 138 000, Manufacturer: Ambu International A/S, DK2750 Ballerup USA: Ambu Inc. (Ambu USA) Linthicum, MD 21090-1356 USA, Made in Denmark
Lower pressure than expected: Medical device for respiratory care may leak and not register accurate flow settings that affect patient respiration.
- 2007-12-22TerminatedProcess design
Ambu, Positive End Expiratory Pressure (PEEP) Valves, PEEP Valve 10, 22/18 mm, 30mm connector, REF 137 001 000, Manufacturer: Ambu International A/S, DK2750 Ballerup USA: Ambu Inc. (Ambu USA) Linthicum, MD 21090-1356 USA, Made in Denmark
Lower pressure than expected: Medical device for respiratory care may leak and not register accurate flow settings that affect patient respiration.
- 2007-12-22TerminatedProcess design
Ambu, Positive End Expiratory Pressure (PEEP) Valves, PEEP Valve Spare Part, REF 137 000 501, Manufacturer: Ambu International A/S, DK2750 Ballerup USA: Ambu Inc. (Ambu USA) Linthicum, MD 21090-1356 USA, Made in Denmark
Lower pressure than expected: Medical device for respiratory care may leak and not register accurate flow settings that affect patient respiration.
- TerminatedDevice Design
Neo-Vent Infant T-Piece Resuscitation Circuit;Circuit for use on compatible Infant Resuscitators. 15mm OD x 10mm ID connector; REF 0415, Qty:10, Length: 60" (1.5cm), Rx Only.
A repair was made to an adapter mold resulting in parts being produced with compliant 10mm ID connections and non-compliant 15mm OD connections. This resulted in facilities with infant resuscitators that connect via the 15mm OD fitting not being able to use those circuits.
- TerminatedDevice Design
Neo-Vent Infant T-Piece Resuscitation Circuit With Infant Mask; Circuit for use on compatible Infant Resuscitators. 15mm OD x 10mm ID connector; REF 0420, Qty:10, Length: 60" (1.5cm), Rx Only.
A repair was made to an adapter mold resulting in parts being produced with compliant 10mm ID connections and non-compliant 15mm OD connections. This resulted in facilities with infant resuscitators that connect via the 15mm OD fitting not being able to use those circuits.
- TerminatedDevice Design
Neo-Vent Infant T-Piece Resuscitation Circuit With Neonatal Mask; Circuit for use on compatible Infant Resuscitators. 15mm OD x 10mm ID connector; REF 0421, Qty:10, Length: 60" (1.5cm), Rx Only.
A repair was made to an adapter mold resulting in parts being produced with compliant 10mm ID connections and non-compliant 15mm OD connections. This resulted in facilities with infant resuscitators that connect via the 15mm OD fitting not being able to use those circuits.
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