MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. BRILLIANCE BIG BORE ONCOLOGY; COMPUTED TOMOGRAPHY X-RAY

Model Number 728243

Device Problem Unintended Movement (3026)

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

Event Type  malfunction  

Manufacturer Narrative

We have not completed our investigation of this event.We will file a follow-up emdr at the completion of the investigation.(b)(4).

Event Description

This complaint has been evaluated based on the information provided; there is no allegation of death or serious injury.The customer reported an issue with horizontal table motion; motion halted though the endless screw continued to turn with horizontal backwards motion.The system was removed from service.This event has been determined to be a reportable event.This event is currently under investigation.

Manufacturer Narrative

The customer reported an issue with horizontal table motion; motion halted though the endless screw continued to turn with horizontal backwards motion.The system was removed from service.The philips field service engineer (fse) went to the customer site to evaluate the system.The fse confirmed the reported problem.The customer noticed the couch wouldn¿t move when they attempted to move the table inside or outside across the bore using the gantry control panel or the tape switch.It didn¿t reach the desired position.The system detected the problem and an error appeared.The fse confirmed this issue occurred prior to the start of a scan.Due to this issue, the customer had chosen to stop using the system and called philips service.The philips fse determined the bearings were stuck and didn´t spin correctly.This issue was caused by ball bearing mechanical wear.The fse replaced the ball bearing and returned the system for clinical use.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: BRILLIANCE BIG BORE ONCOLOGY
• Type of Device: COMPUTED TOMOGRAPHY X-RAY
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.; 595 miner rd; cleveland OH 44143
• MDR Report Key: 8466408
• MDR Text Key: 140605963
• Report Number: 1525965-2019-00011
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• PMA/PMN Number: K033357
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/01/2019

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: Health Professional
• Device Model Number: 728243
• Device Catalogue Number: NCTB104
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/01/2019
• Initial Date FDA Received: 03/29/2019
• Supplement Dates Manufacturer Received: 03/01/2019
• Supplement Dates FDA Received: 06/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1