Ventlab AF5140MBRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10889483103012), received between Oct 18, 2018 and Aug 15, 2025 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Defective Component” (2 reports).

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 15, 2025Component Missing; Component Missing

  IT WAS REPORTED, DURING A CODE BLUE EVENT IN THE CARDIAC PROGRESSIVE CARE UNIT 2E, THE MEDICAL TEAM OPENED THE KIT TO OBTAIN THE AIRFLOW BAG AND DISCOVERED ONLY THE RESUSCITATION BAG WAS IN THE KIT; THE MASK WAS MISSING. ANOTHER AIRFLOW BAG WAS OBTAINED; THE EVENT CAUSED A DELAY IN TREATMENT; HOWEVER, NO PATIENT HARM OR INJURY OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22819447 ↗
• MalfunctionMar 4, 2025Misassembled; Misassembled

  IT WAS REPORTED, DIRECTLY AFTER INTUBATION THE ANESTHESIOLOGIST COULD NOT CONNECT THE AMBU-BAG TO THE ENDOTRACHEAL TUBE (ETT). IT APPEARED THE DEVICE WAS INCORRECTLY ASSEMBLED; THERE WAS NO REPORTED INJURY TO THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 21520852 ↗
• MalfunctionFeb 16, 2024Disconnection; Disconnection

  THE END OF THE RESUSCITATION BAG POPPED OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18727884 ↗
• MalfunctionSep 21, 2023Gas/Air Leak; Gas/Air Leak

  AIR LEAKING DURING INTUBATION, NOT DELIVERING THE PATIENT O2.  OCCURRED DURING PATIENT USE, POSSIBLE DELAY IN TREATMENT.

  Patient problems: Decreased Respiratory Rate

  MAUDE report 17795871 ↗
• InjuryJan 6, 2023Loose or Intermittent Connection; Incomplete or Inadequate Connection; Loose or Intermittent Connection; Incomplete or Inadequate Connection

  PATIENT DISCONNECTED FROM THE VENTILATOR AND PLACED ON AMBU BAG BY ANESTHESIA RESIDENT TEAM. PATIENT MOVED OUT OF OPERATING ROOM AND DOWN H HALLWAYS TO TRANSFER TO ICU. BETWEEN H AND G IT WAS NOTED THE PATIENT WAS DESATURATING AND THE VITAL SIGNS WERE BEGINNING TO DECOMPENSATE. AT THIS TIME, IT WAS NOTED THE AMBU BAG WAS NOT VENTILATING THE PATIENT. ALL CONNECTION AND OXYGEN SUPPLY WERE VERIFIED AND CHECKED. A RESIDENT RAN TO THE OPERATING ROOM TO GET A NEW AMBU BAG AND THE TEAM RUSHED THE PATIENT BACK INTO THE OPERATING ROOM. THE NEW AMBU BAG APPEARED TO FUNCTIONING PROPERLY. VENTILATION WAS VERIFIED BY AUSCULTATION AND HE WAS VENTILATED UNTIL OXYGEN SATURATIONS IMPROVED. THE PATIENT WAS THEN TRANSFERRED TO THE ICU WITHOUT ISSUE.

  Patient problems: Decreased Respiratory Rate

  MAUDE report 16114398 ↗
• MalfunctionNov 18, 2022Defective Component; Defective Component

  BVM MALFUNCTIONED AND PATIENT WAS NOT ABLE TO BE VENTILATED FOR AN UNKNOWN REASON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15827984 ↗
• MalfunctionOct 17, 2022Defective Component; Difficult to Open or Close; Defective Component; Difficult to Open or Close

  THE DUCKBILLED VALVE WOULDN'T OPEN DURING A CODE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15614750 ↗
• MalfunctionOct 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER STATES THAT MASKS ON RESUS BAGS ARE WARPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 7980434 ↗