TEC
Received Jul 10, 2026 · Event occurred Jun 12, 2026
Report 2112667-2026-04400 · MDR key 25778488
Device
Product problems
- Insufficient Flow or Under Infusion
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
A GE HEALTHCARE SERVICE REPRESENTATIVE PERFORMED A CHECKOUT OF THE SYSTEM BUT DID NOT CONFIRM THE REPORTED ISSUE. THERE WAS NO REPORTABLE MALFUNCTION.
Additional Manufacturer Narrative
GE HEALTHCARE¿S INVESTIGATION INTO THE REPORTED OCCURRENCE IS ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED. BLOCK A: PATIENT INFORMATION COULD NOT BE OBTAINED DUE TO COUNTRY PRIVACY LAWS. LEGAL MANUFACTURER: HCS MADISON - 3030 OHMEDA DR, USA MADISON, WI 53718.
Description of Event or Problem
IT WAS REPORTED THAT THERE WAS AN ERROR RESULTING IN INSUFFICIENT AGENT DELIVERY DURING A CASE. THERE WAS NO PATIENT INJURY REPORTED.