MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. BRILLIANCE AIR 40/64/UCT; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Device Problem Unintended Movement (3026)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(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 the couch descended down suddenly during a scan procedure.This malfunction may be likely to cause or contribute to a death or serious injury if this were to recur.Based on the available information, this issue has been initially determined to be a reportable event.

Manufacturer Narrative

The customer, fushun mineral group general hospital, reported that the couch descended down suddenly during a scan procedure.There was no report of patient injury as a result of this issue.The system was in clinical use when this occurred.The philips field service engineer (fse) went on site to evaluate and confirm the reported issue.The couch had dropped down to the floor due to a pin(key) broken in the couch vertical motor.The fse replaced the vertical screw, bearing, and motor to resolve the issue.The parts were sent to the philips engineering for investigation.Philips engineering received the failed parts and a failure analysis was performed.Based on the investigation, a fracturing of the spline hub square key led to a disengagement of the spline hub from the motor shaft, causing the brake function to fail and the couch to descend.The probable cause of the spline hub square key crack was over torque applied on the square key.The fse replaced the vertical screw, bearing, and motor to resolve the issue and returned the system to the customer for use.Internal cross reference: complaint pr# (b)(4).Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• Brand Name: BRILLIANCE AIR 40/64/UCT
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.; 595 miner rd; cleveland OH 44143
• MDR Report Key: 9596311
• MDR Text Key: 200665137
• Report Number: 1525965-2020-00001
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/24/2019

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
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/24/2019
• Initial Date FDA Received: 01/16/2020
• Supplement Dates Manufacturer Received: 12/24/2019
• Supplement Dates FDA Received: 03/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1