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

Model Number 728246

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  

Manufacturer Narrative

(b)(4).On (b)(6) 2014, the customer, (b)(6) hosp, reported that the couch came out too far past its limit, for br 16 air.This complaint is associated with the released service latch, reported by the customer.The system was in clinical use at the time of 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.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 nut to resolve the issue.Fse verified that the service latch was tight.No other service latch complaints have been received from the customer after the service latch was re-secured.The fse alleged that the cause of the service latch is the design flaw.However, the allegations of the fse could not be confirmed by the engineering.A 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 fse re-secured the service latch nut to resolve the issue.The cause of the loose service latch could not be determined based on the information received from the field.

Event Description

The customer reported that the couch came out too far past it's limit.Per the philips field service engineer (fse) the quick lock assembly from the service latch loosened up allowing the couch top to move too far to the rear.The fse confirmed there was no harm to a patient, operator or bystander.The fse retightened the lock to resolve the issue.

• 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: 4692994
• MDR Text Key: 15378389
• Report Number: 1525965-2015-00093
• 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
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 09/03/2014

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: 728246
• Device Catalogue Number: NCTA399
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/03/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2008
• 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