AirFlow AF2142MBS-45ERecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10889483565643), received between Mar 25, 2025 and Dec 18, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Output Problem” (2 reports).

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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 18, 2025Output Problem; Output Problem

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 1314417-2025-00105 FOR THE SECOND REPORT. IT WAS REPORTED, DURING A RESPIRATORY CALL, THE MEDICAL DIRECTOR ATTEMPTED TO USE THE CAPNO-LINE, PACKAGED WITH THE BAG VALVE MASK (BVM), AND NOTED IT DID NOT PROVIDE ANY READINGS. THE LINE WAS DISCONNECTED AND RECONNECTED WITH AN ADDED EXTRA TWIST; HOWEVER, IT STILL DID NOT PROVIDE ANY READINGS. THE LINE WAS SWITCHED TO A NEW DEVICE, WHICH WORKED IMMEDIATELY. THE LACK OF READING HINDERED PATIENT CARE AND DELAYED TREATMENT ON SCENE; HOWEVER, IT WAS NOTED THE PATIENT WAS NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23846179 ↗
• MalfunctionDec 18, 2025Output Problem; Output Problem

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 1314417-2025-00104 FOR THE FIRST REPORT. IT WAS REPORTED, DURING A RESPIRATORY CALL, THE MEDICAL DIRECTOR ATTEMPTED TO USE THE CAPNO-LINE, PACKAGED WITH THE BAG VALVE MASK (BVM), AND NOTED IT DID NOT PROVIDE ANY READINGS. THE LINE WAS DISCONNECTED AND RECONNECTED WITH AN ADDED EXTRA TWIST; HOWEVER, IT STILL DID NOT PROVIDE ANY READINGS. THE LINE WAS SWITCHED TO A NEW DEVICE, WHICH WORKED IMMEDIATELY. THE LACK OF READING HINDERED PATIENT CARE AND DELAYED TREATMENT ON SCENE; HOWEVER, IT WAS NOTED THE PATIENT WAS NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23846178 ↗
• MalfunctionMar 25, 2025Material Deformation; Material Deformation

  IT HAS BEEN REPORTED THAT THE AIRFLOW PEDIATRIC RESUSCITATOR MASK BEING OVAL-SHAPED, MAKING IT DIFFICULT TO CONNECT TO THE BVM, IS A REPORTABLE INCIDENT. THIS ISSUE OCCURS DURING EMERGENCY SITUATIONS, LEADING TO DELAYS IN OXYGEN DELIVERY DUE TO THE MISSHAPEN CONNECTION. SUCH DELAYS COULD RESULT IN SERIOUS HARM OR INJURY IF THE PATIENT DOES NOT RECEIVE OXYGEN QUICKLY ENOUGH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21692355 ↗