MalfunctionCAD
TEC 7
Received Apr 23, 2026 · Event occurred Apr 3, 2026
Report 2112667-2026-02728 · MDR key 24972362
Device
Product problems
- Output below Specifications
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE CUSTOMER DECLINED SERVICE. NO REPAIR INFORMATION AVAILABLE. BLOCK A: NO REPORT OF PATIENT INVOLVEMENT. D4 PRIMARY UDI NUMBER: NO UDI AVAILABLE AS DEVICE WAS MANUFACTURED PRIOR TO UDI COMPLIANCE DATE. 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 AGENT DELIVERED LESS THAN 20% FROM SETTING. THERE WAS NO PATIENT INVOLVEMENT.