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

Model Number BRILLIANCE CT 16 SLICE

Device Problems Unintended System Motion (1430); Device Dislodged or Dislocated (2923)

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

Event Date 08/01/2023

Event Type  malfunction  

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).

Event Description

This complaint has been evaluated based on the information provided; there is no allegation of death or serious injury.The customer reported an issue with the ct couch dropping to its lowest point when moved vertically.Although no harm was reported, there is a risk 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

Philips has investigated the reported problem.According to the information collected, the system was in clinical use when the issue occurred.A philips field service engineer (fse) inspected the system onsite and confirmed that the table fell approximately 200cm to the lowest position while moving the table vertically with a patient.Further investigation revealed that ball screw had fractured.The fse repaired the table by replacing the entire ball screw assembly and the system was returned to use in good working order.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 failure root cause.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 failure root cause.After reviewing all event details, philips engineering confirmed there were no new failure modes.During 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.--- the codes were updated based on the investigation outcome.

• 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: crystal dean ; veenpluis 6; best 5684 -PC ; NL 5684 PC
• MDR Report Key: 17466157
• MDR Text Key: 320515369
• Report Number: 3015777306-2023-00020
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K060937
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BRILLIANCE CT 16 SLICE
• Device Catalogue Number: 728246
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/01/2023
• 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