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

Model Number 728246

Device Problems Mechanical Problem (1384); Device Operates Differently Than Expected (2913); Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

The customer reported that while performing the morning quality assurance testing prior to performing patient clinical procedures, they found the couch upper frame was loose from the lower frame.Per the philips field service engineer (fse) there was no harm to a patient, operator bystander.The fse determined the cause was from the service latch not being engaged.The fse re-secured the service latch to resolve the issue.

Manufacturer Narrative

(b)(4).On (b)(6) 2014, the customer, (b)(6) clinic, alleged that, the lh monitor has power but no video and the service latch is loose and hanging down.The system was not in clinical use at the time of the issue was discovered.The issue was observed while performing the morning quality assurance testing.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 service latch issue, reported by the customer.A separate record will address the issue of the lh monitor having power but no video.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 replaced.After the fse¿s service, the system is working as specified.The inadvertent motion of the sub-frame may cause a potential operator/technician entrapment and pinch point near the couch to gantry interface on the gantry bore side of the couch.The location of the hazard is not in an area where the user would normally be for patient loading/unloading or for operating the system controls from the gantry panel.Furthermore, the patient is not expected to have their arms in the vicinity of the same pinch point area during a clinical scan.Therefore, it is highly unlikely that either the operator or the patient will suffer injury from entrapment or the pinch point gap that results from the displacement between the tabletop and the sub-frame when the service latch is not engaged.Ct engineering determined this would not be likely to cause death or serious injury.Mitigation for this issue includes: service personnel are trained to engage the service latch properly during any service activities that require opening of the gantry front cover.Floating table can be detected by trained personnel during loading/unloading a patient for scanning or loading a phantom for qa checks.A.Brilliance ct ifu (v2.3) section 1.10 ("training").Execution of qa checks per user instructions enables detection of table position errors when loading or unloading phantom.Brilliance ct ifu (v2.3) section 4.4 ("daily checks").Service personnel are instructed to perform auto iq tests (acceptance/constancy and/or quick iq tests) after installation, preventive maintenance (pm), and corrective actions.A.Br 16/16p iq and dose testing instructions (section 1 - introduction).Br 16/16p iq and dose testing instructions (sections 5 & 6, table 3).Execution of auto iq tests, per service instructions, enables detection of table position errors.Br 16/16p iq and dose testing instructions (section 1 - introduction).Br 16/16p iq and dose testing instructions (sections 5 & 6, table 3).For oncology usage, positional accuracy testing using the therapy top calibration phantom enables detection of table position errors.Brilliance ct therapy table top installation instructions.Brilliance therapy table top installation instructions.During a helical scan, per design, cirs shall verify the couch is moving in the direction specified by the host and shall stop the acquisition if the couch positions are not updated as expected.Crep-0202 (ut_boa.Txt, ut_python.Txt).Crel-0476 appendix 4 (verification test results 3.Xlsx).C16u-0541appendix 4 (verification test results) 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.The risk associated with a rescan from a ct scanner is acceptable and poses negligible harm to the patient.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 to resolve the issue.Based on the information provided, the cause of the event 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 ; 4404833000
• MDR Report Key: 4774484
• MDR Text Key: 5777915
• Report Number: 1525965-2015-00058
• 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: 12/19/2014

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: 728246
• Device Catalogue Number: NCTA399
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/19/2014
• Initial Date FDA Received: 05/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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