MalfunctionOWQ
SOUNDSTAR ECO 8F
Received Mar 29, 2021 · Event occurred Mar 24, 2021
Report 11580936 · MDR key 11580936
Device
Generic name
Reprocessed Intravascular Ultrasound Catheter
Manufacturer
Sterilmed, Inc.Model number
R10439011Catalog number
R10439011
Lot number
2148166
Product problems
- Therapeutic or Diagnostic Output Failure
Patient
31755 DA
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
STERILMED REPROCESSED BIOSENSE WEBSTER SOUNDSTAR ECO ULTRASOUND CATHETER SENSOR MALFUNCTION.