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 Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 03/02/2020

Event Type  malfunction  

Event Description

Reporting determination: this complaint has been evaluated based on the information provided; there is no allegation of death or serious injury.The issue reported was that the couch had descended to its lowest limit uncommanded with a patient on it.The couch was about one meter off the ground when this occurred.The patient left the ct department with a complaint of back pain and was pending a doctor assessment.Based on the available information, this issue has been initially determined to be a reportable event.Therefore, this complaint is considered to be a reportable event to the regulatory agency per ha198-004-00 adverse event reporting procedure (ct/nm).This issue is not a reportable radiation event per ha198-005-00 ct/ami radiation event reporting.

Event Description

This complaint has been evaluated based on the information provided; there is no allegation of death or serious injury.The issue reported was that the couch had descended to its lowest limit uncommanded with a patient on it.The couch was about one meter off the ground when this occurred.The patient left the ct department with a complaint of back pain and was pending a doctor assessment.Based on the available information, this issue has been initially determined to be a reportable event.

Manufacturer Narrative

The customer, (b)(4), reported that the patient support couch descended with a patient on it from one meter off the ground.After the issue occurred, the patient complained of back pain and was evaluated by the facility.There was no report of injury received by the patient after the evaluation.The philips field service engineer (fse) went on site to evaluate and confirm the reported issue.The fse evaluated the system and replaced the ball screw assembly to resolve the issue and returned the system to the customer for use.The damaged part(s) was sent to the philips engineering for failure analysis.Failure analysis shows the issue was directly caused by the fracture of the ball screw rod.Further analysis concluded that the fracture surface showed fatigue happened under torsion/bending stress alternating.The probable cause was determined to be excessive radial misalignment between the motor drive and the ball screw.Based on engineering's investigation, the overall residual risk is determined to be acceptable.The following caution is included in current information for users: the philips systems should not be used if any of the following contraindications exist or are thought to exist.¿ the image performance quality assurance checks listed under the heading, maintenance, 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.There is no additional disclosure of residual risks to users necessary because the current information for users would have the user stop use and contact service in the case of suspected problems.Therefore, based on the investigation 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 4-6; best OH 5684 PC; NL 5684 PC
• MDR Report Key: 9887862
• MDR Text Key: 188257235
• Report Number: 1525965-2020-01000
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 00884838083325
• UDI-Public: 00884838083325
• Combination Product (y/n): N
• PMA/PMN Number: K033326
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,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
• Device Operator: Health Professional
• Device Model Number: BRILLIANCE 64 UPGRADES
• Device Catalogue Number: 728231
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 03/02/2020
• Initial Date Manufacturer Received: 03/02/2020
• Initial Date FDA Received: 03/27/2020
• Supplement Dates Manufacturer Received: 03/02/2020
• Supplement Dates FDA Received: 06/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1