MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS, INC. BRILLIANCE CT; SYSTEM, X-RAY, TOMOGRAPHY

Model Number 455011009021

Device Problems Mechanical Problem (1384); Positioning Problem (3009)

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

Event Date 12/17/2018

Event Type  malfunction  

Event Description

During positioning phase with patient, the table locked at start of case.The table would not move.Patient moved to second ct table in department and procedure completed without incident.There was no harm to the patient.

• Brand Name: BRILLIANCE CT
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS, INC.; 595 miner road; cleveland OH 44143
• MDR Report Key: 8302104
• MDR Text Key: 134910093
• Report Number: 8302104
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 455011009021
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/07/2019
• Date Report to Manufacturer: 02/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 25915 DA