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 when the ct system was not in clinical use the couch top was not locked and was drifting in the horizontal direction.Per philips field service engineer (fse) there was no harm to a patient, operator or bystander.The fse secured the service latch to resolve the issue.

Manufacturer Narrative

(b)(4).On (b)(6) 2014, the customer, (b)(6), alleged that during a clinical procedure, the table top is not locking correct, for (b)(4).There was no report of any harm to the operator, patient or bystander during the incident.The operator was able to complete the procedure successfully, there was no rescan/reinjection required.The customer contacted the philips help desk to inform them of the issue.The philips field service engineer (fse) was dispatched to the site.The fse arrived at the site and evaluated the system.Fse determined that the service latch was not secured and re secured the service latch to resolve the issue.No other service latch complaints have been received from the customer after the service latch was re-secured.After the fse's service, the system is working as specified.Ct engineering also determined that there is a potential for undesired radiation to the patient due to carbon top stops/free floats before scan completed.In such cases, the trained professional may determine a rescan is necessary.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 to carbon top stops/free floats before scan completed.In such cases, the trained professional may determine if a rescan is necessary.The risk associated with a rescan from a ct scanner is acceptable.Field safety notification (fsn 72800614) was sent to the field on 08-apr-2014 stating that: if the customer experiences a horizontal, free-floating 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.The cause of the loose service latch could not be determined based on the information received from the field.

• 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: 4692993
• MDR Text Key: 16463698
• Report Number: 1525965-2015-00092
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K033326
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 12/16/2014

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: 12/16/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 1525965-04/08/14-005-C
• Patient Sequence Number: 1