MalfunctionOWQ
SOUNDSTAR ECO 8F DIAGNOSTIC ULTRASOUND CATHETER
Received Jun 27, 2023 · Event occurred Jun 12, 2023
Report 17208379 · MDR key 17208379
Device
Generic name
Reprocessed Intravascular Ultrasound Catheter
Manufacturer
Sterilmed, Inc.Model number
R10439011Catalog number
R10439011
Lot number
2191753
Product problems
- Erratic or Intermittent Display
- Defective Device
- Protective Measures Problem
Patient
17155 DA · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
SOUNDSTAR ECO DIAGNOSTIC ULTRASOUND CATHETER "ICE" CATHETER WAS IN USE, THEN FROZE ON THE SCREEN AND MESSAGE SAID: "NO TRANSDUCER". WE TRIED UNPLUGGING AND PLUGGING IN AGAIN, RESTARTING THE MACHINE, TRYING A NEW DONGLE. WHEN WE GOT A NEW CATHETER, THE ERROR MESSAGE WENT AWAY, SO IT WAS DEDUCED THAT THE CATHETER STOPPED WORKING. THE PATIENT WAS NOT HARMED.