MalfunctionOWQ
SOUNDSTAR ECO 8F DIAGNOSTIC ULTRASOUND
Received Apr 9, 2021 · Event occurred Apr 5, 2021
Report 11640484 · MDR key 11640484
Device
Generic name
Reprocessed Intravascular Ultrasound Catheter
Manufacturer
Sterilmed, Inc.Model number
R10439011Catalog number
R10439011
Lot number
2147431
Product problems
- Erratic or Intermittent Display
Patient
21535 DA
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
IMAGE WAS REVERSED WHEN REPROCESSED SOUNDSTAR ECO DIAGNOSTIC ULTRASOUND CATHETER WAS CONNECTED. NEW CATHETER USED WORKED PROPERLY.