MalfunctionOWQ
SOUNDSTAR ECO 8F DIAGNOSTIC ULTRASOUND CATHETER
Received Nov 9, 2021 · Event occurred Oct 25, 2021
Report 12778307 · MDR key 12778307
Device
Generic name
Reprocessed Intravascular Ultrasound Catheter
Manufacturer
Sterilmed, Inc.Model number
R10439011Catalog number
R10439011
Lot number
2161705
Product problems
- Defective Component
- Communication or Transmission Problem
Patient
27375 DA · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
SENSOR ERROR, NEW DONGLE USED, PROBLEM PERSISTED. NEW SOUNDSTAR OPENED, PROCEDURE COMPLETED WITHOUT INJURY TO PATIENT.