MalfunctionOWQ
SOUNDSTAR ECO 8F
Received Jun 9, 2023 · Event occurred May 31, 2023
Report 17097181 · MDR key 17097181
Device
Generic name
Reprocessed Intravascular Ultrasound Catheter
Manufacturer
Sterilmed, Inc.Model number
R10439011Catalog number
R10439011
Lot number
2191026
Product problems
- No Display/Image
Patient
30295 DA · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
ICE (INTRACARDIAC ECHOCARDIOGRAPHY) CATHETER INSERTED BUT DID NOT SHOW ON SCREEN. CABLE REPLACED. THEN CATHETER REPLACED. NO HARM TO PATIENT.