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 HealthModel number
WCAEX9605ACatalog 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.