MalfunctionCAD
TEC
Received Jul 13, 2026 · Event occurred Jun 15, 2026
Report 2112667-2026-04426 · MDR key 25795823
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 AND CONFIRMED THE REPORTED ISSUE. THE ACTUATOR ASSEMBLY WAS CALIBRATED TO RESOLVE THE ISSUE. BLOCK A: NO REPORT OF PATIENT INVOLVEMENT. LEGAL MANUFACTURER: HCS MADISON - 3030 OHMEDA DR, USA MADISON, WI 53718.
Description of Event or Problem
IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN INSUFFICIENT AGENT DELIVERY LESS THAT -20% OF SETTING. THERE WAS NO PATIENT INVOLVEMENT.