MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. BRILLIANCE 40

Model Number 728235

Device Problems Disconnection (1171); Noise, Audible (3273)

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

Event Type  malfunction  

Event Description

In this case the customer reported that they heard a loud clank from the patient table and the table top became free-floating.Philips service confirmed that there was no harm to a patient, operator or bystander and that there was no patient involvement at the time.Philips service replaced the wing nut with the nylock nut and washer to resolve the issue.

Manufacturer Narrative

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

Manufacturer Narrative

(b)(4).The customer reported to philips on (b)(6) 2014 that they heard a loud clank from the patient table during routine geometry/mechanical movement testing, and the table top became free-floating on their brilliance 40 ct scanner.There is no patient involvement with the system during routine qa (quality assurance) testing.A philips field service engineer (fse) was notified and sent to the site to resolve the issue.Philips service confirmed that there was no harm to a patient, operator or bystander and that there was no patient involvement at the time.The fse evaluated the system and found that the sub frame lock had become loose and was not securely fastened.Philips service replaced the wing nut with the nyloc nut and washer to resolve the issue and the ct system was returned to clinical use.The service lock is only released during preventive maintenance (pm) or corrective maintenance (service visits) in order to move the couch to access the gantry.Since there were no parts returned from the field or log files provided, a root cause of the issue could not be determined by engineering.However, based upon the troubleshooting services and statements of the fse, a probable cause of the service latch being loose is that it was not sufficiently secured by the fse following previously completed maintenance on (b)(6) 2014.Additional evaluation of this complaint has been conducted and philips ct engineering determined this issue to be an acceptable risk and if the malfunction were to recur and the service latch were to become disengaged after servicing, prior to a patient procedure or during a patient procedure, it would not be likely to cause or contribute to death or serious injury.Based on the risk benefit analysis, trending of the complaint records and a clinical evaluation by a medical physician, it has been determined that service latch failures do not meet the definition of a medical device report.There is no evidence that the service latch failure has resulted in a serious injury or death or could cause or contribute to a serious injury or death if the malfunction were to recur.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.Execution of qa checks per user instructions enables detection of table position errors when loading or unloading phantom.Service personnel are instructed to perform auto iq tests (acceptance/constancy and/or quick iq tests) after installation, preventive maintenance (pm), and corrective actions.Execution of auto iq tests, per service instructions, enables detection of table position errors.For oncology usage, positional accuracy testing using the therapy top calibration phantom enables detection of table position errors.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.Operators/users of the system are specifically trained to position a patient in such a way that there is enough play in all indwelling lines and catheters to allow for the table motion that is expected during the scan.There has been no report of injury to a patient, operator or bystander as a result of the service latch becoming disengaged.Therefore this complaint is considered to be a non-reportable event to the regulatory agency per (b)(4) adverse event reporting procedure (ct/nm), which ensures compliance with the requirements of adverse event reporting worldwide.The product safety committee includes information related to the correction and removal documents for this issue including field safety notification ((b)(4)) that was sent to the field on (b)(6) 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.

• Brand Name: BRILLIANCE 40
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.; 595 miner rd.; cleveland OH 44143
• Manufacturer Contact: kumudini carter ; 595 miner rd; cleveland, OH 44143 ; 4404833000
• MDR Report Key: 4188679
• MDR Text Key: 5099826
• Report Number: 1525965-2014-00172
• 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,company representati
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 09/18/2014

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: 728235
• Device Catalogue Number: NCTA402
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/18/2014
• Initial Date FDA Received: 10/17/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/23/2016
• 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