MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. BRILLIANCE AIR 40/64/UCT; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Device Problems Mechanical Problem (1384); Mechanical Jam (2983); Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that when the ct couch is commanded by the gantry control panel to go "up", the couch moves "down".The philips field service engineer (fse) confirmed there was no harm to a patient, operator or bystander.The fse determined by the logs that the "unload" button on the right ct gantry control panel was intermittently sticking causing the couch to move in the opposite direction than requested.The fse replaced the right ct gantry control panel to resolve the issue.

Manufacturer Narrative

On 30-jul-2015, the customer (b)(6) reported that when the patient support was commanded to go upwards, it moved downwards.A philips field service engineer (fse) stated that the device was not in clinical use when the issue occurred and there was no harm to a patient, operator or bystander as a result of this issue.The fse stated that the patient support motion stopped when the button was pressed again.The customer contacted the philips help desk to inform them about the event.The customer support specialist (css) found an error indicating that the home button (unload) on the gantry right-side panel was stuck.The fse was then dispatched to the site.The fse evaluated the system and found that the unload button on the front right gantry control panels were stuck engaged.The fse replaced front right gantry control panel assembly to resolve the issue.The fse provided the defective panel and log files for engineering evaluation.Engineering evaluated this issue and the following observations were made: occurrences of stuck button error messages were documented in the on the system log files; small amounts of dried white substance were present in the openings surrounding all the buttons; misalignment was found and is more pronounced on the patient unload button, requiring more force to push and slowing its return; the patient unload button became stuck for two minutes after depressing it several times; the bench test was repeated with the cover removed.None of the buttons became stuck or failed with the cover removed.Therefore, it concludes that stuck patient unload button was caused by misalignment after sometime use and dried white substance around the button.Ct engineering determined this issue to have acceptable risk with the following mitigations: the system implements multiple means to prevent un-commanded motion and single point of failure.These means include watchdog timer for drive tasks, redundant switches in the control panel buttons, collision envelope avoidance software, providing emergency stop buttons and emergency power-off (epo) for the user in case of failure of other design mitigations.A failure during motion could be caused either by a software defect in the embedded operating system used or a defect in the control logic implementation, and the system was unable to detect that.The failure could only occur during the time where the operator initiated motion via the control panel.In this case the operator is in contact with the patient and visually watching the motion and would see the couch continue to move after the button was released.The trained operator would use the emergency stop control to stop the motion.Also, design mitigations for prevention of the hazardous situations: stopping horizontal motion in the presence of resistance force (not applicable for vertical); table collision envelope.Single fault safe against uncontrolled motion: motion tasks watchdog timer.If maximum time of control response is exceeded, e-stop will be activated; double switches on control buttons provides redundancy such that 2 switches must be activated before a motion is executed.Design mitigations enabling human response: continuous activation for manual motion; emergency stop controls enable termination of motion in hazardous condition; emergency power off switch supplied with system or site installation enables the operator to shut off power to the entire system; speed of motorized non-programmed motion is limited.

• Brand Name: BRILLIANCE AIR 40/64/UCT
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• 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: 5004986
• MDR Text Key: 23961616
• Report Number: 1525965-2015-00225
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Report Date: 07/30/2015

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
• 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: 08/14/2015
• 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
• Patient Sequence Number: 1