MalfunctionOWQ
SOUNDSTAR ECO 8F DIAGNOSTIC ULTRASOUND CATHETER
Received Nov 17, 2022 · Event occurred Nov 3, 2022
Report 15814381 · MDR key 15814381
Device
Generic name
Reprocessed Intravascular Ultrasound Catheter
Manufacturer
Sterilmed, Inc.Model number
R10439011Catalog number
R10439011
Lot number
2179353
Product problems
- Poor Quality Image
Patient
25185 DA · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IMAGE QUALITY NOT ACCEPTABLE. GRAINY. IN BODY. NO PATIENT HARM.