MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. BRIGHTVIEW XCT; SYSTEM, TOMOGRAPHY, COMPUTED, EMISSION

Catalog Number 882482

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Type  malfunction  

Event Description

This complaint has been evaluated based on the information provided; there is no allegation of death or serious injury.The trained operator reported that the camera touchscreen was used for a procedure set up and the gantry rotated unexpectedly.Based on additional information from field safety notice (fsn) 88200521/ hhe ami 1123-2019 it has been determined this record is a reportable event.A field safety notice (fsn) has been released to customers indicating that an issue has been found with the hand controller for the brightview family of cameras.The issue results in either spontaneous uncommanded (not initiated by the operator) motions or continued motion after the buttons were released.

Manufacturer Narrative

The customer reported that they selected a total body pre-programmed motion (ppm) on the touchscreen and unexpectedly the gantry rotated at a high speed.A patient was on the table when this issue occurred and the operator pressed an emergency stop (e-stop) button to stop the gantry rotation.There was no report of system contact or injury as a result of this event.A philips field service engineer (fse) went on site to evaluate and confirm the reported issue.The customer reported the same issue had occurred in the past and is addressed in (b)(4).The fse inspected the system.The fse proactively replaced the motor controller.All of the available information was sent to philips engineering who confirmed the issue is due to a software issue.The system is in clinical use.This issue is not related to (b)(4) as originally reported in the initial report.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• Brand Name: BRIGHTVIEW XCT
• Type of Device: SYSTEM, TOMOGRAPHY, COMPUTED, EMISSION
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.; 595 miner rd; cleveland OH 44143
• MDR Report Key: 8798487
• MDR Text Key: 151431717
• Report Number: 1525965-2019-00037
• Device Sequence Number: 1
• Product Code: KPS
• Combination Product (y/n): N
• PMA/PMN Number: K080927
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 05/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 882482
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1