inforMED
MalfunctionCAH

CARDINAL HEALTH

Received Jul 12, 2026 · Event occurred Jun 4, 2026

Report 2028807-2026-00011 · MDR key 25791696

Device

Generic name

Adult Circuit, 96in Expandable Tbg

Manufacturer

Cardinal Health

Model number

WCAEX9605A

Catalog number

WCAEX9605A

Lot number

UNKNOWN

Product problems

  • Loose or Intermittent Connection
  • Connection Problem

Patient

Not reported

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

IT WAS REPORTED THAT THE CERTIFIED RESPIRATORY NURSING ASSISTANT (CRNA'S) REPORTED THAT THE CIRCUITS WERE DISCONNECTING DURING CASES WHICH RESULTED IN THE PATIENTS REMAINING "LIGHT" AND NOT GETTING THE GAS THEY NEED. THERE WAS NO REPORT OF A DELAY IN THERAPY, HARM OR INJURY AS A RESULT OF THIS REPORTED EVENT.

Additional Manufacturer Narrative

THE PRODUCT INVOLVED IN THE REPORT HAS NOT BEEN RETURNED.A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS.ALL INFORMATION REASONABLY KNOWN AS OF 11 JULY 2026 HAS BEEN INCLUDED IN THE HEALTH AUTHORITY REPORT. SHOULD ADDITIONALINFORMATION BE OBTAINED A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY AIRLIFE. REPRESENTS ALLOF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WASUNABLE 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 FACILITYWHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AIRLIFE COMPLAINT DATABASE AND IS IDENTIFIED AS COMPLAINT(b)(4)THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOTBE CONSIDERED TO BE AN ADMISSION THAT A AIRLIFE PRODUCT IS DEFECTIVE OR CAUSES SERIOUS INJURY.