MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. BRILLIANCE 16 AIR; COMPUTED TOMOGRAPHY X-RAY

Model Number 728246

Device Problems Detachment Of Device Component (1104); Mechanical Problem (1384); Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Event Description

The customer reported that the service latch has been released.The philips field service engineer (fse) confirmed there was no harm to a patient bystander, or operator.The fse confirmed the service latch was not secured and resecured the latch to resolve the issue.

Manufacturer Narrative

(b)(4).On (b)(6)-2013, the customer reported that the table moving short distance vertically and service latch has been released.The philips field service engineer (fse) confirmed there was no harm to a patient, bystander, or operator.The field service engineer (fse) confirmed that the service latch had come loose.Fse determined that the vertical string was off its connector and encoder belt was broken.The fse replaced the vertical encoder belt.The gantry was restarted several times so e-stop would close.The vertical calibration failed due to bad string pot.New string pot was ordered by fse and replaced on (b)(6)-2013 and recalibrated vertical table.No other service latch complaints have been received from the customer after the service latch was re-secured.This complaint is associated with the released service latch, reported by the customer.The complaint number (b)(4) will address the issue of short distance vertical movement of the table.A review of the service work orders ((b)(4)) showed that the last service done (before this event) on the site was on (b)(6)-2013.During this service, the fse addressed the issue of distorted 1 image during cta images.A field safety notification (fsn (b)(4)) was sent to the field on (b)(6)-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 fse re-secured the service latch to resolve the issue.Since the fse was not sure of the cause of the unsecured service latch, a root cause could not be determined.

• Brand Name: BRILLIANCE 16 AIR
• 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: 4680441
• MDR Text Key: 5623601
• Report Number: 1525965-2015-00079
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K012009
• 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
• Type of Report: Initial
• Report Date: 11/12/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 728246
• Device Catalogue Number: NCTA399
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/12/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1