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

Device Problems Loss of Power (1475); Device Inoperable (1663); Positioning Problem (3009)

Patient Problem No Information (3190)

Event Date 10/14/2015

Event Type  malfunction  

Event Description

The table to ct machine would not respond, the table was not responding properly when attempted to lower it.After several attempts to lower the table, the power to the gantry suddenly was lost.Delays to patient imaging and care as this is the only ct scanner in house.

• Brand Name: BRILLANCE
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 595 miner rd; cleveland, OH 44143
• MDR Report Key: 5426815
• MDR Text Key: 37936218
• Report Number: 5426815
• 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: Nurse
• Type of Report: Initial
• Report Date: 11/24/2015,02/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/24/2015
• Event Location: Hospital
• Date Report to Manufacturer: 11/24/2015
• 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 Outcome(s): Other