MAUDE Adverse Event Report: BRILLIANCE ICT; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number BRILLIANCE ICT

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 04/12/2021

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: 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 issue reported was that 3 days after the installation of a cooling unit (clu) on a brilliance ict system, the customer reported a whooshing sound from the gantry and then the clu was expelled out of the gantry.This occurred during a patient procedure while the rotor was in motion.A philips field service engineer (fse) confirmed that there was no harm to the patient or operator.Based on the available information, this issue has been determined to be a reportable event.

Manufacturer Narrative

The customer reported a whooshing sound from the gantry and then the cooling unit (clu) was expelled out of the gantry.This occurred during a patient procedure while the rotor was in motion.A philips field service engineer (fse) confirmed that there was no harm to the patient or operator.The patient was removed from the system.On (b)(6) 2021, the clu for the ict system was replaced.During the replacement installation of the clu, the fse noted that the new clu was mechanically different from the part that was removed, however did not recognize the difference in part numbers.The fse continued with the installation of the clu using the existing fasteners.On (b)(6) 2021, the clu was expelled out of the ct gantry while scanning a patient resulting in damage to the system and system enclosure covers.All of the available information was sent to philips engineering which concluded the following: the clu for the ict system was replaced with a clu with a different part number using the existing fasteners.The clu became detached due to insufficient fastener thread engagement.The probable cause was incorrect part ordering and replacement by the philips fse.Internal cross reference: complaint pr# (b)(4).Health impact code: c50675; no apparent harm occurred in relation to the adverse event.

• Brand Name: BRILLIANCE ICT
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• MDR Report Key: 11673441
• MDR Text Key: 248161291
• Report Number: 3015777306-2021-10002
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• PMA/PMN Number: K162838
• 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

• Date FDA Received: 04/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BRILLIANCE ICT
• Device Catalogue Number: 728306
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 04/12/2021
• Date Manufacturer Received: 04/12/2021
• 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