MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. BRILLIANCE 64; COMPUTED TOMOGRAPHY X-RAY

Model Number 728231

Device Problems Detachment of Device or Device Component (2907); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

The customer reported that the service latch was loose and the table was free floating.The philips customer support specialist (css) confirmed there was no harm to a patient, bystander,·or operator.The css assisted the maintenance technician with re-securing the service latch to resolve the issue.

Manufacturer Narrative

Pr#: (b)(4).On (b)(6) 2014, the customer, (b)(6), reported that the table is floating loosely and it was moving up and down in small increments, for (b)(4).The system was in clinical use at the time the issue was discovered.There was no report of any harm to the operator, patient or bystander during the incident.The customer contacted the philips help desk to inform them of the issue.This complaint is associated with free floating of the patient support reported by the customer.The complaint number (b)(4) will address the issue of the table movement up and down in small increments.The philips customer support services (css) assisted the maintenance technician, over the phone, with re securing the service latch to resolve the issue.The philips css notified field service engineer (fse) about the event.Fse spoke to customer over the phone about the process of securing the service latch.No other service latch complaints have been received from the customer after the service latch was re-secured.Ct engineering determined that the overall risk is acceptable.Ct engineering also determined that there is a potential for undesired radiation to the patient due o carbon top stops/free floats before scan completed.In such cases, the trained professional may determine a rescan is necessary.The risk associated with a rescan from a ct scanner is acceptable.A field safety notification (fsn 72800614) that was sent to the field on 08-apr-2014 stating that: if the customer experiences a horizontal, freefloating couch motion, they have to contact their field service engineer immediately.A copy of this field safety notice has to be retained with the equipment instructions for use (ifu).Additionally, the service manual is being revised to provide more robust instructions on how to service the patient support.The service manual changes are internal philips documents.Since the fse was not sure of the cause of the unsecured service latch, a root cause could not be determined.See scanned page.

• Brand Name: BRILLIANCE 64
• Type of Device: COMPUTED TOMOGRAPHY X-RAY
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.; 595 miner rd.; cleveland OH 44143
• Manufacturer Contact: nancy drake ; 595 miner rd.; cleveland, OH 44143 ; 4404833032
• MDR Report Key: 4693001
• MDR Text Key: 5718278
• Report Number: 1525965-2015-00098
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033326
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,User Facility
• Reporter Occupation: Health Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 07/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 728231
• Device Catalogue Number: NCTB423
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/04/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2005
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: C&R 1525965-04/08/14-005
• Patient Sequence Number: 1