MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. BRILLIANCE 64; COMPUTED TOMOGRAPHY X-RAY

Model Number 728231

Device Problems Sticking (1597); Device Operates Differently Than Expected (2913); Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Internal cross reference: (b)(4).

Event Description

The customer reported that the couch button was broken.A philips field service engineer (fse) confirmed that there was no harm to a patient, operator or bystander.The fse reported that while loading a patient for their procedure, the operator used the down button on a gantry control panel and the bed raised to the top position.The fse reported that the patient was removed from the system in a controlled fashion and the procedure was completed on another system.The fse evaluated the system logs which contained an s_command_button_stuck_error error and determined that the right rear gantry control panel had failed.The fse replaced the right rear control panel to resolve the issue.

Manufacturer Narrative

On 14-sep-2015, the customer reported that the up button on the gantry panel was broken.A philips field service engineer (fse) confirmed that there was no harm to a patient, operator or bystander associated with this issue.The fse reported that while loading a patient, prior to starting the procedure, the operator used the down button on a gantry control panel but the patient support moved upwards instead.The fse reported that the patient was removed from the system in a controlled fashion and the procedure was completed on another system.The operator contacted philips help desk to inform them of the event and the fse was dispatched to the site.The fse arrived on site and evaluated the system.The fse found that when the patient support was in the highest position (15) , and when the down button was pressed on the gantry panel, the patient support moved downwards and stopped at the position of 85.But when the fse pressed the down button again, the couch started to move up until it reached the highest position (15) again.The fse then reviewed the system logs which contained an error.The fse determined that the up button on the right rear gantry control panel was stuck engaged causing the incorrect upward movement of the patient support.The fse replaced the right, rear control panel to resolve the issue.No log files or defective parts were provided for engineering analysis.Since there were no parts returned from the field, a cause of the issue could not be determined by engineering.However, based upon the troubleshooting services and statements of the fse, the issue occurred due to stuck button on the rearm right gantry control panel.The fse replaced the right, rear gantry control panel to resolve the issue.Ct engineering determined this issue to be an acceptable risk.If this malfunction were to recur and the gantry vertical control panels would move the couch in a direction that they were not supposed to move, vertical movement down or up when selected would also move the couch in the in direction.It would be 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 gantry panel stuck button failures do not meet the definition of a medical device report.There is no evidence that the gantry panel stuck button 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.The following mitigations for this issue include: ¿all systems are equipped with emergency stop as well as power off buttons which provide an immediate means for the operator inside the scan room or in the control room to stop any unintended table motion, including such resulting from a stuck gantry panel button.The emergency stop buttons are very obvious and located immediately adjacent to the gantry panels and within reach of an operator moving the table by depressing any of the gantry buttons in question.¿the system performs a test for stuck buttons during initialization.¿a collision calculation is done in each combination of vertical, horizontal, or tilt motion, preventing injury from collision.¿motion control software verifies that motion commands are executed otherwise a fault condition is assumed and stops motion.¿resistance protection is in place for couch horizontal motion, a force limit to pallet motion beyond which motion will stop and shutdown.¿instructions in the instructions for use to observe the patient during all movements of the patient support.¿table movement that is driven by the precision motors happens at a controlled low speed.This provides ample time for recognition of unwanted movement.At the same time it provides an opportunity for most patients to respond to unintended positions resulting from such table movement.¿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 serious injury to a patient, operator or bystander as a result of this malfunction of the gantry control panel.Since there were no parts returned from the field, a cause of the issue could not be determined by engineering.

• Brand Name: BRILLIANCE 64
• 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: 5144864
• MDR Text Key: 28472410
• Report Number: 1525965-2015-00266
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K033326
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Followup
• Report Date: 09/14/2015

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: 728231
• Device Catalogue Number: NCTB423
• 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: Not provided
• Initial Date FDA Received: 10/13/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/05/2015
• 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