MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. BRILLIANCE 64

Model Number 728231

Device Problems Loose or Intermittent Connection (1371); Noise, Audible (3273)

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

Event Type  malfunction  

Event Description

The customer has reported that the couch is making a loud banging noise when the couch top is moved in the horizontal direction with the tape switch.There is no noise under power.The field service engineer (fse) reported that there was no harm to a pt or operator.The fse reported that the service latch under the couch had become loose and he tightened the retainer to secure the latch.System is operational.

Manufacturer Narrative

(b)(4).On (b)(6) 2014, the customer at (b)(6) healthcare (b)(6) reported an issue with the table on their brilliance 64 ct scanner.The customer reported that the table is not free flowing, and the table is making noises when moving horizontally with the tape switch.The customer reported no noise occurs under power, but during geometry/mechanical movements.The customer does not want to use system due to noise when moving pt manually.There was no report of harm to any pt, operator, or bystander.On (b)(4) 2014 a philips field service engineer (fse) was scheduled to the customer site.On (b)(4) 2014 the fse checked the system table and found that the latch to hold the table top in place had become loose.The fse tightened down the nut for the latch to resolve the issue.On (b)(4) 2014 preventive maintenance had been performed on the system.The service lock is only released during preventive (planned) maintenance (pm) or service visits in order to move the couch to access the gantry.If the latch is not properly secured, there is the possibility for it to become loose over time.This issue was submitted for engineering eval: when a failure of the latch occurs, the couch upper subframe is allowed to move, taking with it the carbon top and potentially any pt 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 pt support (table) during clinical use for scanning and pt 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.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 clinic scans would not cause injury to the pt.The inadvertent motion of the sub-fram 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 pt loading/unloading or for operating the system controls from the gantry panel.Furthermore, the pt 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 pt 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.Correction and removal 1525965-04/08/14-005-c was submitted this issue, including field safety notification (fsn # 72800614) that was sent to the field on 04/01/2014 stating that: if the customer experiences a horizontal, free-floating couch motion, they have to contact their field service engineering immediately.A copy of this field safety notice has to be retained with the equipment instructions for use (ifu).This customer has confirmed receipt of fsn # 72800614.The probable cause of the service latch becoming loose is that it was not sufficiently secured by the fse following preventive maintenance.The fse locked the service latch to resolve the issue.Internal cross reference: complaint pr# (b)(4).

• Brand Name: BRILLIANCE 64
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.; 595 miner rd.; cleveland OH 44143
• Manufacturer Contact: kumudini carter ; 595 miner rd.; cleveland, OH 44143 ; 4404833032
• MDR Report Key: 4004744
• MDR Text Key: 4776006
• Report Number: 1525965-2014-00136
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033326
• 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: 06/26/2014

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: 728231
• Device Catalogue Number: NCTB423
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/26/2014
• Initial Date FDA Received: 07/25/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2007
• 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