MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. BRILLIANCE 10 AIR; COMPUTED TOMOGRAPHY X-RAY

Model Number 728251

Device Problems Mechanical Problem (1384); Device Inoperable (1663)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

The customer reported to the philips customer service that the service latch for the table top was broken and a new service latch was needed.The philips field service engineer (fse) confirmed there was no harm to a patient, bystander, or operator and there was no free floating of the couch.The fse replaced the service latch with the new style service latch to resolve the issue.

Manufacturer Narrative

(b)(4).On (b)(6) 2014, the customer, dickson medical associates-tn, alleged that, the service latch for the table top was broken and a new service latch was needed, for br 10 air 728251.There was no report of any harm to the operator, patient or bystander during the incident.The system was not in clinical use at the time the issue was discovered.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 broken and there was no free floating of the couch.The fse replaced the service latch with the new style to resolve the issue.No other service latch complaints have been received from the customer after the service latch was replaced.Preventive maintenance is performed in accordance with the brilliance ct planned maintenance manual.When a failure of the latch occurs, the couch upper subframe is allowed to move, taking with it the carbon top and potentially any patient on the carbon top at the time of failure.There is no motor or drive for this, as the movement of the sub frame is designed to be manual by service.This latch is not intended to be disconnected during clinical use.The couch movement is achieved by motors in the subframe, which is latched in place relative to the base, and which drives the patient support (table) during clinical use for scanning and patient loading/unloading.If the subframe is not latched to the base, the couch could become free floating at the subframe interface, rather than the carbon top.This free floating motion is similar to the motion that the trained user would notice when the tape-switch is used in emergency extractions.The users perform regular quality assurance (qa) testing, including image quality (iq) tests, as part of scanner maintenance.During the qa testing, the user contacts the couch during manual loading/unloading of the system phantom during which the trained user would notice the free floating (i.E., disengaged) state of the couch.If the service latch is not engaged, and the user does not detect the free floating of the couch, there could be couch position errors introduced during clinical scans or qa checks that may not be reported by the system as an error to the operator.However, such couch position errors can introduce iq test failures during qa checks and incorrect positioning during clinical scans which may be detectable by the operator.Therefore, it is expected that a trained operator would not proceed to a clinical scan if qa check failed.Additionally, it is also expected that any incorrect positioning which could occur during clinical scans would not cause injury to the patient.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 issue to be an acceptable risk.The following mitigations for this issue include: a.Service personnel are trained to engage the service latch properly during any service activities that require opening of the gantry front cover.B.Floating table can be detected by trained personnel during loading/unloading a patient for scanning or loading a phantom for qa checks.¿brilliance ct ifu (v2.3), section 1.10 (¿training¿).C.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.¿ v2.2.1 through 2.3.7 6-16p performance manual.¿execution of auto iq tests, per service instructions, enables detection of table position errors.¿v2.2.1 through 2.3.7 6-16p performance manual.D.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.E.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.The fse replaced the service latch with the new style to resolve the issue.Based on the information provided, the cause of the event could not be determined.

• Brand Name: BRILLIANCE 10 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: 4766046
• MDR Text Key: 5947708
• Report Number: 1525965-2015-00130
• 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: 08/26/2014

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: 728251
• Device Catalogue Number: NCTA397
• 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: 08/26/2014
• Initial Date FDA Received: 05/12/2015
• 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: N/A
• Patient Sequence Number: 1