Ventlab AF2142MBRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10889483090237), received between Apr 3, 2024 and Apr 3, 2024 — classified as 1 death.

The most frequently reported specific device problem is “Connection 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• DeathApr 3, 2024Disconnection; Connection Problem; Disconnection; Connection Problem

  PRODUCT COMPLAINT # (B)(4) REGARDING OUR ITEM # 87-AF2142MBEA- RESUS, PED, AIRFL, MAN, POP-OFF (SUNMED # AF2142MB). OUR CUSTOMER, STEPHANIE EDWARDS, HAS REPORTED "AMBU BAGS / TAPED TO BACK / O2 TUBE THRU INSIDE COMES OUT END HOOK TO O2 SOURCE / TUBE THT GOES TO BACK/EXHAST TEETHIN IS NOT CONNECTED TUBE IS COMING OUT. CUSTOMER STATES THE PAITENT DID EXPIRE BUT DID NOT FEEL BECAUSE OF THIS . THEY HAD TO USE 4 BAGS DUE TO TUBE COMING OUT." PER THE CONVERSATION WITH PRODUCT QUALITY, NO INJURY/DEATH WAS INVOLVED - (B)(6) (COMPLAINTANT).

  Patient problems: No Clinical Signs, Symptoms or Conditions; Respiratory Failure

  MAUDE report 19038189 ↗