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

Device Problems Unintended System Motion (1430); Device Operates Differently Than Expected (2913); Positioning Problem (3009)

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 they pressed the buttons on the gantry control panel, the couch might do the opposite of what was requested and the foot switch does not work.Philips field service engineer (fse) confirmed there was no harm to a patient, operator or bystander.The fse found the right gantry control panel buttons were sticking intermittently.The fse ordered new gantry control panels.

Manufacturer Narrative

(b)(4).On (b)(6) 2015, the customer reported that while positioning the patient, the patient support moved in the opposite direction to what was commanded or would tilt when using gantry panel buttons or the footswitch.A philips field service engineer (fse) confirmed that there was no harm to a patient, operator or bystander as a result of this issue.This was the second occurrence of this issue at the site.The issue occurred the first time on (b)(6) 2015, which is addressed by a subsequent complaint.The customer contacted the fse after the second occurrence, and the fse arrived at the site.The fse evaluated the system and found that the buttons on the gantry control panels were sticking intermittently.The fse disconnected the front, right and left gantry control panels, and the erratic motion issue went away.The fse ordered new panels and advised the customers to use the rear panels, ct box, and footswitch for patient positioning until the replacements arrived.The fse replaced the front, right and left control panel assemblies respectively to resolve the issues.The fse also stated that one of the causes for the buttons sticking was due to finding contrast and other debris inside the buttons and on the board.No log files were provided for engineering analysis.The fse provided the defective panels for engineering evaluation.This complaint has been determined to be a similar complaint to the primary complaint which documents the investigation details.Ct engineering investigated this issue and determined it to be an acceptable risk.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.¿ controllers 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.¿ 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: a) horizontal node watchdog timer.If maximum time of control response is exceeded, e-stop will be activated.B) 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.

Event Description

The customer reported that when they pressed the buttons on the gantry control panel, the couch might do the opposite of what was requested and the foot switch does not work.Philips field service engineer (fse) confirmed there was no harm to a patient, operator or bystander.The fse found the right gantry control panel buttons were sticking intermittently.The fse ordered new gantry control panels.

• 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: 4975261
• MDR Text Key: 23586145
• Report Number: 1525965-2015-00217
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 07/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2015
• 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
• Date Manufacturer Received: 07/20/2015
• 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