inforMED
MalfunctionJAK

BRILLIANCE 64 CT

Received Sep 29, 2023 · Event occurred Sep 15, 2023

Report MW5146306 · MDR key 17852750

Device

Generic name

System, X-ray, Tomography, Computed

Model number

BRILLIANCE CT

Patient

20 YR · Male

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

ON (B)(6) 2023, AN X-RAY EXAMINATION WAS PERFORMED FOR THE PATIENT. WHEN ENTERING THE BED, THE RACK WAS POWERED OFF. AFTER COMMUNICATING WITH THE PATIENT, THE EXAMINATION WAS SUSPENDED WITHOUT ANY ADVERSE EFFECTS ON THE PATIENT. NOTIFIED THE EQUIPMENT DEPARTMENT TO ARRIVE ON SITE FOR REPAIRS. SITUATION OF COMBINED MEDICATION/DEVICE: NA. DISCLAIMER STATEMENT: THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).