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

Model Number BRILLIANCE 64 UPGRADES

Device Problem Unintended System Motion (1430)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/19/2023

Event Type  malfunction  

Event Description

Reporting determination: this complaint has been evaluated based on the information provided.The customer reported that while positioning a patient, the ct couch suddenly dropped downward.There was no report of harm.The patient was moved to another ct system where the exam was completed successfully.There is potential of serious injury if this issue were to recur, therefore this event is considered reportable.Philips has started an investigation of this complaint.

Manufacturer Narrative

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

Manufacturer Narrative

The philips field service engineer (fse) evaluated the system and confirmed the vertical ball screw was broken.The fse replaced the vertical ball screw and bearings of the couch.All couch motion was tested and passed.The system was then returned 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.Internal cross reference: complaint (b)(4).

Manufacturer Narrative

The issue reported was that while positioning a patient, the ct couch suddenly dropped downward when being raised in the vertical direction.There was no report of harm to patient or operator as a result.The patient was moved to another ct system where the exam was completed successfully.A philips field service engineer (fse) confirmed the table moved without command or notice and dropped approximately 15 inches to its point.The fse inspected the system onsite and determined the ball screw was broken which caused the event.The ball screw assembly and vertical drive and motor were replaced.Following the repair, the system was tested successfully and returned to the customer for use.In this case, the parts were collected and sent to the suzhou (sz) factory for inspection by the sz research and development (r&d) department.Analysis confirmed that the vertical ball screw had fractured.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.However, a further material analysis was requested and 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
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer Contact: matthew jolliff ; veenpluis 6; best 5684 -PC ; NL 5684 PC
• MDR Report Key: 16916775
• MDR Text Key: 315076255
• Report Number: 3015777306-2023-00010
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 00884838083325
• UDI-Public: 00884838083325
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K033326
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BRILLIANCE 64 UPGRADES
• Device Catalogue Number: 728231
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/19/2023
• Was Device Evaluated by Manufacturer?: No
• 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