MalfunctionCBZ
TEC
Received Sep 18, 2024 · Event occurred Aug 23, 2024
Report 2112667-2024-05104 · MDR key 20247184
Device
Product problems
- Infusion or Flow Problem
- Infusion or Flow Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE CUSTOMER DECLINED SERVICE. NO REPAIR INFORMATION AVAILABLE.
Additional Manufacturer Narrative
A GE HEALTHCAREÂS INVESTIGATION INTO THE REPORTED OCCURRENCE IS ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED. NO REPAIR INFORMATION AVAILABLE. 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 AGENT DELIVERED LESS THAN 20% FROM SETTING. THERE WAS NO PATIENT INVOLVEMENT.