Cardinal Health

Description of Event or Problem

It was reported that the circuits were disconnecting during procedures, resulting in patients remaining inadequately anesthetized and not receiving the required anesthetic gas. There was no reported serious harm or injury associated with this event. AirLife received a single report that referenced two different incidents, which were associated with separate units. This is the first of two reports. Refer to 2028807-2026-00016 for the second report.

Additional Manufacturer Narrative

The product involved in the report has NOT been returned for evaluation. A review of the Device History Record is in-progress. All information reasonably known as of 24 July 2026 has been included in this Health Authority Report. Should additional information be obtained, a Follow-up Health Authority Report will be provided. The information provided by AirLife represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to AirLife. AirLife has no independent knowledge of the event reported, but is relaying the information that was provided by the user facility where the incident occurred. This product incident is documented in the AirLife complaint database and identified as (b)(4). This information is submitted pursuant to 21 CFR 803, in compliance with the medical device reporting requirement, and should not be considered to be an admission that an AirLife product is defective or caused serious injury.