MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. BRILLIANCE 16 AIR

Model Number 728246

Device Problems Break (1069); Noise, Audible (3273)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

The customer reported that when they turned the ct system on, the couch moved down and the table top damaged the gantry cover, causing a noise when rotation occurs.Philips service confirmed that there was no harm to a patient, operator or bystander.There was no patient involvement when the system was turned on.Philips service evaluated the system and determined that a failed advance control system (acs) motion controller had caused the couch top to move horizontally, not vertically, and contact the gantry.This contact resulted in the gantry cover being scratched and the lexan ring being knocked out of position, which caused the noise during gantry rotation.Philips service replaced the acs controller and repositioned the lexan ring to resolve the issue.

Manufacturer Narrative

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).On (b)(6) 2013, the customer reported that when they turned their system on, the couch moved down and the table top damaged the gantry cover, causing a noise when rotation occurs.The customer stopped using the scanner until philips service could reboot and test it.There was no patient involvement when the system was turned on.The customer contacted philips help desk to inform them of the issue and an fse was dispatched to the site.Philips service confirmed that there was no harm to a patient, operator or bystander.On (b)(6) 2013, the philips fse arrived on site and evaluated the system and the log files.The fse indicated the customer¿s operator was going to scan a patient but the gantry lights were off.She turned the key to turn on the gantry but it would not turn on.She tried this twice.She then scanned the patient on another ct scanner.Later she went back to the scanner and shut it down at the wall power.She turned it on and went she got the gui on the screen to turn the key, she turned the gantry on.She said the couch then moved down and into the gantry.The table top hit the window ring and pushed it back a little.She turned the key off to stop the table from moving.No patient was on the table operating room in the room when this occurred.When the fse arrived, he observed that the table top would move in by itself as soon as he turned the key on.The table top would move in very fast and then stop, then move in very fast and then stop, until the key was turned off.He also observed that the advance control system (acs) controller did not have a readout number.It was blank.The error log was showing problems with the acs.The fse determined that the acs did not boot up correctly after the customer turned the wall power back on.He then shut the system down to the wall power, waited, and then turned the power back on.He turned the gantry off and then on and the gantry and table booted up ok.He ran test scans, checked all table cables, checked the table power supplies and everything was ok.The system booted up normally as did the acs and the acs had a number 1 on it.He ran a test scan and it worked ok.The system worked ok until the fse returned to replace the acs.The logs only indicated a problem with the acs controller, which handles only horizontal motion of the couch, not vertical.He could find no evidence on any incorrect vertical motion, only the horizontal.The operator was only certain that the table had contacted the gantry, not of the actual movement and assumed that the motion that caused the contact with the gantry was vertical.The fse was able to duplicate the horizontal motion problem.The rotational noise was the result of the couch hitting the gantry cover and knocking the clear ring out of position.The fse reviewed the error logs, which showed that the horizontal motor controller did not know where the table top was.The fse determined that the acs did not boot up correctly after the customer turned the wall power back on.The fse spoke with the customer care solution center (ccsc) who recommended replacing the encoder and the acs controller.The fse determined that a failed acs motion controller had caused the couch top to move horizontally, not vertically, and contact the gantry.This contact resulted in the gantry cover being scratched and the lexan ring being knocked out of position, which caused the noise during gantry rotation.On (b)(6) 2013 the fse replaced the acs controller but then it failed.On (b)(6) 2013 the fse replaced the acs controller with a new (second) replacement and repositioned the lexan ring to resolve the issue.Since replacing the acs there has been no problem with the couch.After adjusting the ring, the contact was eliminated and noise ceased.On (b)(6) 2014, ct engineering received the original failed acs for evaluation and checked the function.Engineering determined that the message "1" did not display on the acs, meaning the acs could not communicate with the system.No error logs were available for engineering to review.By design, couch horizontal motion can only occur after software initialization is finished.At such time, the couch software would send out the horizontal clutch close command to engage the horizontal clutch.Since the acs could not finish initialization due to the communication failure, the couch could not have moved horizontally.It is most likely that the motion was actually vertical.Vertical motion, in conjunction with failed horizontal encoders, would allow the couch to potentially impact the cover due to the system not knowing the couch was in the bore.Ct engineering determined the risk to be acceptable.The following mitigations for this issue include: two, redundant monitors are controlling the motion.A collision calculation is done in each combination of vertical, horizontal, or tilt motion.Hw emergency stop button stops all the motions.Buttons test during initialization.Instructions in instruction for use to observe patient during all movements.When scan starts, the cirs checks for correct direction and that spiral motion does not stuck.Controller software verifies that commanded motions are executed or a fault condition is assumed.Couch horizontal motion shall shutdown if a linear force greater than 40 pound for regular couch or 70 pound for bariatric and extended couch is encountered while moving.Design ensures that there is motion during a scan procedure and is redundantly measured by examining both horizontal position encoders.When the couch has the ¿bedrock¿ configuration, couch horizontal linear shutdown force shall be in the range of 70-80 pounds.

• Brand Name: BRILLIANCE 16 AIR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.; 595 miner rd.; cleveland OH 44143
• Manufacturer Contact: kumudini carter ; 595 miner rd; mr training department; cleveland, OH 44143 ; 4404833032
• MDR Report Key: 3597164
• MDR Text Key: 4067474
• Report Number: 1525965-2014-00012
• 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,company representati
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/20/2013

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
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/20/2013
• Initial Date FDA Received: 01/16/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/08/2015
• 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