inforMED
MalfunctionIYN

EPIQ 7C ULTRASOUND SYSTEM

Received Apr 14, 2023 · Event occurred Mar 23, 2023

Report 16742279 · MDR key 16742279

Device

Generic name

System, Imaging, Pulsed Doppler, Ultrasonic

Model number

795201

Product problems

  • Display or Visual Feedback Problem
  • Unexpected Shutdown

Patient

16425 DA · Unknown

  • Insufficient Information
  • Insufficient Information

Narrative

Description of Event or Problem

THE ECHO ULTRASOUND DEVICE SHUT DOWN DURING A STRUCTURAL HEART CASE. THE ERROR CODE ON THE UNIT STATED, "RECONNECT THE TRANSDUCER AND RESELECT. DIAGCODE: 007". THE ECHO TECH HAD TO BRING IN A NEW UNIT IN THE ROOM TO FINISH THE CASE. MANUFACTURER RESPONSE FOR ULTRASOUND SYSTEM, EPIQ 7C (PER SITE REPORTER). THE PHILIPS SERVICE REP WAS CALLED OUT TO REPAIR THE UNIT. WE ARE WAITING ON RESPONSE.