Ventlab AF2140MBPRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10889483088111), received between May 26, 2023 and Jan 26, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Material Integrity Problem” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Oct 11, 2023Open, Classified

   A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.

   Z-0361-2024 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 26, 2024Pressure Problem; Pressure Problem

  PATIENT PRESENTATION: AN UNRESPONSIVE PATIENT, HELMETED DRIVER OF A MOTORCYCLE STRUCK BY ANOTHER VEHICLE AT A HIGH RATE OF SPEED THEN STRUCK AND RUN OVER BY AN ADDITIONAL VEHICLE, WAS ASSESSED WITH A GLASGOW COMA SCALE (GCS) SCORE OF 3, INDICATIVE OF SEVERE CONSCIOUSNESS IMPAIRMENT. MEDICAL INTERVENTIONS: RAPID SEQUENCE INTUBATION (RSI) WAS PERFORMED TO ESTABLISH AIRWAY PATENCY. THE ENDOTRACHEAL TUBE (ETT) WAS VENTILATED WITH AN ADULT SUNMED (AF2140MBP) MANUAL RESUSCITATOR WITH A MANOMETER, POSITIVE END-EXPIRATORY PRESSURE (PEEP) VALVE SET AT 5 CMH2O, HEAT AND MOISTURE EXCHANGE FILTER (HMFE), IN-LINE END-TIDAL CO2 (ETCO2) SENSOR AND CONNECTED TO A 15 L/MIN OXYGEN SOURCE. FIC02 ELEVATION ISSUE: WHILE USING THE SUNMED MANUAL RESUSCITATOR, THE PATIENT'S FRACTION OF INSPIRED CO2 (FICO2) LEVELS INCREASED UNTIL THE CLINICAL TEAM PLACED THE PATIENT ON A VENTILATOR. THIS INCREASE BEGAN AT 14:38.36 (FIGURE 1) AND PEAKED AT 20 MMHG AT 14:42.13 (FIGURE 2). FICO2 LEVELS FLUCTUATED BETWEEN 10 AND 20 MMHG (FIGURE 3) UNTIL THE PATIENT WAS TRANSITIONED TO A VENTILATOR AT 14:49.51. THE ELEVATION IN FICO2 RESOLVED ONCE THE VENTILATOR WAS INITIATED (FIGURE 4). PRODUCT PROBLEM: SUSPICIONS ARISE THAT T

  Patient problems: Decreased Level of Consciousness

  MAUDE report 18592409 ↗
• MalfunctionMay 26, 2023Material Integrity Problem; Material Integrity Problem

  BAGS AREN'T HOLDING PRESSURE.

  Patient problems: Unspecified Respiratory Problem

  MAUDE report 17014849 ↗