TEC 7
Received Jun 9, 2026 · Event occurred May 12, 2026
Report 2112667-2026-03769 · MDR key 25442684
Device
Product problems
- Insufficient Flow or Under Infusion
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE CUSTOMER DECLINED GE HEALTHCARE SERVICE. NO REPAIR INFORMATION AVAILABLE.
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: NO PATIENT INFORMATION PROVIDED TO DATE AFTER CALLS TO END USER 05/15/26 AND 05/22/26. BLOCK D4 PRIMARY UDI NUMBER: THERE IS NO UDI AVAILABLE AS THE DEVICE WAS MANUFACTURED PRIOR TO UDI COMPLIANCE REQUIREMENTS. LEGAL MANUFACTURER: HCS MADISON - 3030 OHMEDA DR, USA MADISON, WI 53718.
Description of Event or Problem
IT WAS REPORTED THAT THERE WAS A MALFUNCTION DURING A CASE RESULTING IN AGENT DELIVERED LESS THAN 20% FROM SETTING. THERE WAS NO PATIENT INJURY.