MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS BRILLIANCE 64; SYSTEM, X-RAY, COMPUTED TOMOGRAPHY

Device Problems Display or Visual Feedback Problem (1184); Communication or Transmission Problem (2896)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/24/2018

Event Type  malfunction  

Event Description

The technician scanned the patient for his ct angiogram.After the scan, the computer would not reconstruct the images.Because no images could be seen, a report was unable to be dictated.The scanner and computer were not talking to each other.

• Brand Name: BRILLIANCE 64
• Type of Device: SYSTEM, X-RAY, COMPUTED TOMOGRAPHY
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 595 miner rd.; cleveland OH 44143
• MDR Report Key: 7323246
• MDR Text Key: 101856860
• Report Number: 7323246
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/30/2018,02/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/30/2018
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/30/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 20 YR