Ventlab AF5140MBPRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10889483074725), received between Dec 15, 2022 and Apr 5, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 5, 2024Inflation Problem; Inflation Problem

  OXYGEN WAS COMING THROUGH TUBING BUT BLOWING OUT OF SIDE VALVE. BAG WOULD NOT INFLATE & COULD NOT GET OXYGEN TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19055616 ↗
• MalfunctionNov 3, 2023Material Integrity Problem; Material Integrity Problem

  WHEN BAG WAS SQUEEZED NO AIR WAS BEING DELIVERED TO THE PATIENT. PATIENT STATS DROPPED RAPIDLY, RECOVERED FAST AFTER SWITCHING THE BAG. AMBU WAS NOT FUNCTIONING PROPERLY. AMBU WAS BEING SQUEEZED, NUT NO CHEST RISE VOLUME NOT BEING DELIVERED TO PT DESPITE ORAL AIRWAY IN PLACE AND A GOOD SEAL ON A MASK ON PT'S FACE. PT WAS BEING INTUBATED AND PT'S DESATED TO 74%, UNTIL A NEW AMBU WAS GRABBED FROM ANOTHER ROOM AND PT'S SATS INCREASED INTO THE 90'S AND PT WAS SUCCESSFULLY INTUBATED. OLD AMBU AND BAG OBTAINED FROM ROOM PULLED

  Patient problems: Respiratory Insufficiency

  MAUDE report 18068626 ↗
• MalfunctionJun 23, 2023Material Integrity Problem; Material Integrity Problem

  THE VALVE ATTACHED TO THE BVM WAS NOT FUNCTIONING. THE DOCTOR WAS IN THE PROCESS OF INTUBATING THIS PATIENT. THE RESPIRATORY THERAPIST WAS TRYING TO BAG THE PATIENT PRIOR TO THE DOCTOR PLACING THE TUBE. THE DOCTOR WAS HAVING SOME DIFFICULTY WITH THE INITIAL TUBE SIZE. HE OPTED TO SELECT A DIFFERENT SIZE. AT THIS TIME WE NOTICED THE PATIENT'S OXYGEN SATURATION STARTED TO DROP. THE RESPIRATORY THERAPIST SEEMED TO BE HAVING TROUBLE GETTING A GOOD SEAL WITH THE BAG VALVE MASK. AT THIS TIME PATIENT CARE TECH ASSISTED IN BAGGING WHILE THE RESPIRATORY THERAPIST HELD A GOOD CE CLAMP. THE TECH NOTICED THE BAG SEEMED TO BE A LITTLE EASY TO SQUEEZE AND WE DID NOT OBSERVE ANY CHEST RISE WHILE BAGGING. THE PATIENT'S OXYGEN SATURATION CONTINUED TO DROP. THE DOCTOR THEN FINISHED THE INTUBATION. THE TECH GOT ANOTHER BAG-VALVE-MASK (BVM) FROM THE OMNICELL. THE PATIENT'S OXYGEN SATURATION IMMEDIATELY CAME UP INTO THE UPPER 90S. AFTER COMPLETING THE INTUBATION STAFF CHECKED THE PREVIOUS BVM. IT APPEARS THE VALVE ATTACHED TO THE BVM WAS NOT FUNCTIONING. IT APPEARED THE AIR COMING THROUGH THE BAG ENTERED THE VALVE AND CAME OUT BETWEEN THE VALVE AND THE BAG INSTEAD OF THE EXITING THROUGH THE VALVE INTO

  Patient problems: Low Oxygen Saturation

  MAUDE report 17195277 ↗
• MalfunctionJun 1, 2023Material Integrity Problem; Material Integrity Problem

  BAGS NOT HOLDING PRESSURE.

  Patient problems: Unspecified Respiratory Problem

  MAUDE report 17043503 ↗
• MalfunctionDec 15, 2022Incorrect Measurement; Incorrect Measurement

  THE PATIENT WAS IN CRITICAL CONDITION IN THE ICU REQUIRING EMERGENT INTUBATION. FOLLOWING ADMINISTRATION OF RSI DRUGS, BVM VENTILATION WAS CARRIED OUT WITH NOTED CHEST RISE THIS WAS THE FIRST USE FOR THE RESUSCITATION BAG. THE PATIENT WAS INTUBATED AND VENTILATION WAS RESUMED WITH RESUSCITATION BAG. THE PATIENT THEN BEGAN TO DETERIORATE SUDDENLY. OXYGEN SATURATION WAS DECREASING AND BREATH SOUNDS COULD NOT BE VERIFIED. THERE WAS NO CHEST RISE. THE ENDOTRACHEAL TUBE WAS VISUALIZED TO BE IN PROPER POSITION. IT WAS NOTED THAT THERE WAS NO PRESSURE REGISTERING ON THE MANOMETER WHILE SQUEEZING THE RESUSCITATION BAG. THE BAG WAS DISCONNECTED AND THE BAG WAS SQUEEZED WHILE OCCLUDING PATIENT PORT. AGAIN, THERE WAS NO PRESSURE MEASUREMENT ON THE MANOMETER. STAFF OBTAINED A REPLACEMENT RESUSCITATION BAG AND RESUMED VENTILATION WITH IMMEDIATE IMPROVEMENT IN THE PATIENT CONDITION AND CHEST RISE AND BILATERAL BREATH SOUNDS WERE VERIFIED. PATIENT WAS STABILIZED AFTER APPROXIMATELY 2 MINUTES OF TROUBLESHOOTING AND TIME TO OBTAIN REPLACEMENT RESUSCITATION BAG. THERE WAS NO PRESSURE REGISTERING ON THE MANOMETER WHILE SQUEEZING THE RESUSCITATION BAG.

  Patient problems: Low Oxygen Saturation

  MAUDE report 15987832 ↗