MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. BRILLIANCE 16 AIR; COMPUTED TOMOGRAPHY X-RAY

Model Number 728246

Device Problems Loose or Intermittent Connection (1371); 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).On (b)(6) 2013, the customer, reported that at the end of a patient ct clinical procedure, the operator was moving the couch out of the gantry and down.When they released the button the couch went back in towards the gantry about eight inches.Upon further investigation, the customer indicated this has happened three times in the last month.The dates of the other occurrences are unknown.This record will be for the third occurrence, two subsequent complaints have been submitted for the other two occurrences.In this case the customer reported that at the end of a patient ct clinical procedure, the operator was moving the couch out of the gantry and down.When they released the button the couch went back in towards the gantry about eight inches.There was no report of harm to a patient or operator.The customer contacted philips help desk to inform them of the issue and an fse was dispatched to the site.On (b)(4) 2013, the fse arrived on site and evaluated the system.Upon evaluation, the fse was unable to duplicate the problem.The couch and support operation was tested with the controls and the horizontal calibration was performed with no problems on the same day as the problem occurred.On (b)(4) 2013, the following parts were replaced: the safety cable, cable harness adapter, cable harness table plate, potentiometer lead.The fse thought w716 could be the problem.He also had swapped out two cables which had the same pin out.The fse determined that the issue occurred due to a failed cable in the couch control circuit.The parts were provided for engineering assessment.No log files were available.Engineering investigation of the defective parts, concluded that the replaced cable had a loose connector pin.Engineering determined the most probable cause of the issue was a failed cable in the couch control circuit.Ct engineering determined that the risk for this event was acceptable and, the mitigations for this issue include: ¿ vertical motion locked by additional brake when power is off.¿ 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.¿ when the couch has the ¿bedrock¿ configuration, the geared motor shall hold the couch at maximum load when the motor brake is not functional or removed.

Event Description

The customer reported that at the end of a patient ct clinical procedure the operator was moving the couch out of the gantry and down and when they released the button the couch went back in towards the gantry about eight inches.The field service engineer determined the cause was from a failed cable in the couch control circuit.There was no report of harm to a patient or operator.

• Brand Name: BRILLIANCE 16 AIR
• Type of Device: COMPUTED TOMOGRAPHY X-RAY
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.; 595 miner rd; cleveland OH 44143
• Manufacturer (Section G): PHILLIPS MEDICAL SYSTEMS; 595 miner rd; mr training department; cleveland OH 44143
• Manufacturer Contact: dan brown ; 595 miner rd; cleveland, OH 44143 ; 4404833000
• MDR Report Key: 5269203
• MDR Text Key: 32927616
• Report Number: 1525965-2015-00299
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/17/2013

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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/17/2013
• Initial Date FDA Received: 12/04/2015
• 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