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

Model Number BRILLIANCE CT 16 SLICE

Device Problem Unintended System Motion (1430)

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

Event Date 06/27/2023

Event Type  malfunction  

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: complaint (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 that vertical movement of the ct couch failed and caused the couch to descend rapidly to its lowest position.The system was in clinical use with patient on the table, however the patient was not injured.A field service engineer (fse) evaluated the system and determined the ball screw had failed.The fse replaced the ball bearing and ball screw assembly and tested all couch motion which passed.The system was then returned to the customer for clinical use.We are considering this event reportable out of abundance of caution.Philips has started an investigation of this complaint.

Manufacturer Narrative

The philips field service engineer (fse) went to the site and found that it was not possible to raise the table vertically upwards using motorized controls.Further inspection of the table was performed and the fse determined that the table motor inverter and brake had failed.There was an incidental finding of ball screw wear and tear.The fse replaced the brake and inverter.The ball screw and ball screw coupling were proactively replaced, and the system was 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 customer, yichang city central people's hospital, reported that vertical movement of the brilliance 16 ct couch failed and caused the couch to descend rapidly to its lowest position.The system was in clinical use with a patient on the table.The patient was not injured, and no medical intervention was necessary.Philips has investigated the reported problem.A philips field service engineer (fse) inspected the system onsite and found that raising the table vertically using motorized controls was not possible.Further troubleshooting confirmed the vertical motor inverter and vertical brake had failed which caused the table to descend 500mm to its lowest point.Additionally, the fse observed normal wear and tear of the ball screw.The fse replaced the vertical brake and inverter to resolve the issue.The ball screw and ball screw coupling were proactively replaced, and the system was returned to use in good working order.Philips engineering reviewed all event details and confirmed that the vertical motor brake holds the load/patient in its vertical position while vertical motion stops.When brake failure happens, the weight of the table¿s upper frame and that of the patient will cause the ball screw and motor to rotate reversely.The unintended reverse motor rotation may cause inverter failure.In this case, brake sticking/adhesion occurred, which means the brake couldn't function properly to provide enough holdup torque.In conclusion, the root cause was a vertical motor brake failure.The possible causes of vertical motor brake failures include inadequate brake maintenance, incorrect use of the brake, or insufficient control signals of the motor brake.Vertical brake replacement and conducting planned maintenance following the instructions for use would solve the issue.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 image performance quality assurance checks listed in the technical reference guide, have not been satisfactorily completed.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 was a vertical motor brake failure.A review of the risk management file indicates the problem 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.These codes were updated based on the investigation outcome: evaluation results code.Component code.Conclusion code.

• Brand Name: BRILLIANCE
• Type of Device: SYSTEM, TOMOGRAPHY, COMPUTED, EMISSION
• 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: beth johnson ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 17279641
• MDR Text Key: 318641288
• Report Number: 3015777306-2023-00019
• 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: Health Professional,User Facility,Company Representative
• 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

• Date FDA Received: 07/07/2023
• 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: 06/27/2023
• 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