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 during a ct clinical patient procedure, the patient support was free floating.The philips field service engineer (fse) confirmed that there was no harm to the patient, operator, or bystander.The fse determined that the service latch was not engaged and became loose.The fse re-secured the service latch to resolve the issue.

Manufacturer Narrative

(b)(4).We have not completed our investigation of this event.We will file a follow-up emdr at the completion of the investigation.(b)(4).

Manufacturer Narrative

On (b)(6)-2015, the customer, (b)(6), reported that while attempting to reposition the patient support, it free floating.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 of the issue was discovered.The customer contacted the philips help desk to inform them of the issue.A remote support engineer (rse) instructed the customer over the phone to re-secure the service latch.The customer 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 service, the system is working as specified.The activities performed by the rse is documented in a service work order.There was no part replacement.No field service engineer (fse) was dispatched to the customer site.On 5-jun-2015, (b)(4) was contacted to inform them of the rse instruction to the customer, to perform repair actions on the system.Preventive maintenance is performed in accordance with the brilliance ct planned maintenance manual , which directs to the brilliance ct 6-64 system planned maintenance introduction gantry cover removal / installation procedures (page 12) stating: "brilliance 6-64 gantry cover removal and installation procedures are located in the brilliance 6-64 gantry repair and replacement manual." the brilliance ct gantry repair and replacement manual (4535 670 87081 rev ad), opening the gantry front cover (page 70) states: "1) ensure the patient support top is as far away from the gantry as it will go.2) unscrew the wing nut or nut on the subframe quick release located under the front of the patient support.Unscrew it enough so that the other end will drop out of the slot in the bracket it engages.3) move the patient support subframe away from the gantry.Note that it may take considerable force to move the subframe out of its normal position.However, after the initial resistance is overcome, the patient support subframe should move freely." also, in figure 3 - 1: lower patient support subframe quick release, closing the gantry front cover (page 73) it states: "9) re-engage the patient top subframe support quick-release at the front of the patient support by pushing the end of it up until it engages the slot in the top bracket.10) tighten the wing nut on the quick release." 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 becomes 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: 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) (¿training¿).¿ execution of qa checks per user instructions enables detection of table position errors when loading or unloading phantom.A.Brilliance ct ifu (v2.3) (¿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.V3.6 - br 16/16p iq and dose testing instructions (section 1 - introduction).B.V3.6 - br 16/16p iq and dose testing instructions (sections 5 & 6, table 3).C.Execution of auto iq tests, per service instructions, enables detection of table position errors.D.V3.6 - br 16/16p iq and dose testing instructions (section 1 - introduction).E.V3.6 - 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.A.Brilliance ct therapy table top installation instructions p.17.B.Brilliance therapy table top installation instructions p.10.¿ 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.A.Crep-0202 (rev 2) - (ut_boa.Txt, ut_python.Txt).B.Crel-0476 (rev 01) - appendix 4 (verification test results 3.Xlsx).C.C16u-0541 (rev 1.3) - appendix 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 per white paper.The product safety committee binder includes information related the correction and removal documents for this issue including field safety notification (fsn 72800614) that 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.Initially, these customers were not confirmed to be on the units affected list 72800614 to receive fsn 72800614.On 24-jun-2015 the market group was advised that this customer also needed to be provided the fsn.A remote support engineer (rse) instructed the customer over the phone to re-secure the service latch.The cause of the event could not be determined based on the information provided.However, the customer re-secured the service latch 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 ; 4404833000
• MDR Report Key: 4788533
• MDR Text Key: 5803943
• Report Number: 1525965-2015-00142
• 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,Followup
• Report Date: 04/23/2015

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/23/2015
• Initial Date FDA Received: 05/21/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/02/2015
• 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