A5 Anesthesia SystemRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 06944904030272), received between Jul 8, 2025 and Jul 8, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K123211, K171311); they may or may not involve this specific model.

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

• MalfunctionJul 8, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING FIRST USE OF THEIR MACHINE AFTER A PREVENTIVE MAINTENANCE, WHEN VENTILATING A PATIENT, THE A5 PRODUCED A CONTINUOUS AIRWAY PRESSURE ALARM AND WOULD NOT VENTILATE PROPERLY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22435985 ↗
• MalfunctionJul 8, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING FIRST USE OF THEIR MACHINE AFTER A PREVENTIVE MAINTENANCE, WHEN VENTILATING A PATIENT, THE A5 PRODUCED A CONTINUOUS AIRWAY PRESSURE ALARM AND WOULD NOT VENTILATE PROPERLY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22435979 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K123211, K171311. One submission often covers many models, so check the product and lot details in each record.

• Z-0846-2018 · Jul 14, 2017 · Terminated
  A-Series A3/A5 Anesthesia Delivery System; Model Numbers: 0633F-01000-0X (A3) and 0631F-01000-0X (A5) Product Usage: The A-Series Anesthesia System is a device used to administer