MalfunctionOWQ
SOUNDSTAR ECO 8F
Received Mar 19, 2021 · Event occurred Mar 10, 2021
Report 11527103 · MDR key 11527103
Device
Generic name
Reprocessed Intravascular Ultrasound Catheter
Manufacturer
Sterilmed, Inc.Model number
R10439011Catalog number
R10439011
Product problems
- No Display/Image
- Defective Device
Patient
26645 DA
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
NO ICE IMAGE AFTER TROUBLESHOOTING. DEFECTIVE ABLATION CATHETER.