MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. BRILLIANCE; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number	BRILLIANCE 64 UPGRADES
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Philips engineering has not completed the investigation of this event.We will file a follow-up emdr at the completion of the investigation.Internal cross reference: (b)(4).
Event or Problem Description
The issue reported was that while moving the patient support in the vertical (up) direction, the couch automatically descended (down) to its lowest position.The system was in clinical use during the event; however, there was no injury reported.A philips field service engineer (fse) evaluated the system and found the ball screw and bearing were broken.We are considering this event reportable out of abundance of caution.Philips has started an investigation of this complaint.
Additional Manufacturer Narrative
The philips field service engineer (fse) evaluated the system and confirmed that the couch (patient support) would not lift up or move down vertically.The fse observed that the vertical ball screw was broken.The fse replaced the ball screw and applicable bearings of the couch (patient support) and then tested all couch motion and returned the system to the customer for clinical use.Note: this investigation is still in process therefore, we have not completed our investigation of this event.We will file a follow-up emdr at the completion of the investigation.
Additional Manufacturer Narrative
The issue reported was that while moving the patient support in the vertical (up) direction, the couch automatically descended to its lowest position.The system was in clinical use during the event; however, there was no injury reported.A philips field service engineer (fse) evaluated the system onsite and determined the couch (patient support) ball screw and bearing were broken, which caused the event.The fse replaced the ball screw assembly and vertical drive.Following repair, the system was tested successfully and returned to the customer for use.In a similar incident (such as reported in this case), a philips fse collected the vertical ball screw and bearing parts and returned them to the suzhou (sz) factory for a failure analysis.Analysis confirmed the vertical ball screw was fractured and a further material analysis was performed by a 3rd party lab (suzhou metal service co.Ltd).According to the analysis, the ball screw failure was caused by a fatigue fracture.In addition to the analysis, ball screw inventory was checked, and the parts met drawing specifications.Therefore, a material and supplier quality issue was excluded for root cause failure.Couch manufacturing process for ball screw alignment and installation were also checked through tolerance stack up and production couch alignment accuracy measurement.The calculation determined the production alignment met specification.Sampling checked the production couch measurement accuracy, and all were within specifications.Therefore, couch manufacturing was excluded for root cause failure.After reviewing all event details, philips engineering confirmed there were no new failure modes.During the site inspection, the philips fse found the upgrade kit was not installed on the couch in the previous ball screw replacement and the alignment of the ball screw replacement was not performed per the service manual; the alignment tool was designed to avoid misalignment during ball screw replacement.Additionally, the philips ct system is intended to be used and operated only in accordance with the safety procedures and operating instructions given in the instructions for use for the purpose for which it was designed.Operators of the philips system must have received adequate training on its safe and effective use before attempting to operate the equipment described in the instructions for use.The philips systems should not be used if any of the following conditions exist or are thought to exist.The preventative maintenance program is not up to date.If any part of the equipment or system is known (or suspected to be) operating improperly.During all movements of the gantry and the patient table (automatic and manual), keep the patient under continuous observation.Make sure that the patient is strapped securely to avoid dangling of the hands.Ensure that the patient is placed securely on the patient table and is not in danger of falling.In conclusion, the root cause of the ball screw failure was determined to be fatigue due to misalignment from no use or partial use of the ball screw service install kit.A review of the risk management file indicates the issue reported by the customer is of low potential severity, which would not reasonably cause or contribute to death or serious injury if the problem were to reoccur.Therefore, based on the investigation¿s conclusion, this issue has been determined not to be a reportable event.

• Brand Name: BRILLIANCE
• Common Device Name: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; high tech campus 36; eindhoven 5656A E; NL 5656AE
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; high tech campus 36; eindhoven 5656A E; NL 5656AE
• Manufacturer Contact: matthew jolliff ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 17048638
• Report Number: 3015777306-2023-00017
• Device Sequence Number: 5044560
• Product Code: JAK
• UDI-Device Identifier: 00884838083325
• UDI-Public: 00884838083325
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K033326
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup

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
• Operator of Device: Health Professional
• Device Model Number: BRILLIANCE 64 UPGRADES
• Device Catalogue Number: 728231
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/14/2023
• Supplement Date Received by Manufacturer: 05/14/2023; 05/14/2023
• Initial Report FDA Received Date: 06/02/2023
• Supplement Report FDA Received Date: 06/29/2023; 12/15/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown