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 when preparing to scan the patient ,the couch suddenly descended to the lowest position.The patient was seen by a doctor who determined there was no injury.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, kunming yan'an hospital, reported that when preparing to scan a patient, the couch suddenly descended to the lowest position with the patient on the couch.The patient then felt neck discomfort and was dizzy.The patient was seen by a doctor who determined there was no injury.The system was in clinical use when this event occurred.The philips field service engineer (fse) went on site to evaluate and confirm the reported issue.The fse found that the ball screw had malfunctioned and that ball bearing drops were seen on the couch base from the ball screw which led to the couch descending to its lowest position.The fse replaced the vertical ball screw and bearings of the couch to resolve the issue and returned the system to the customer for use.The fse then returned the failed ball screw to philips engineering for analysis.Philips engineering received the failed ball screw and a failure analysis was performed.The findings concluded that the probable cause was a failure of the ball screw nut causing the ball screw not to fully support the scissor slides causing the table to descend to its lowest position.The fse replaced the vertical ball screw and bearings of the couch to resolve the issue at the customer site.Internal cross reference: complaint pr# 10161032 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: 9607828
• MDR Text Key: 200667746
• Report Number: 1525965-2020-00002
• 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: 01/07/2020

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: 01/07/2020
• Initial Date FDA Received: 01/20/2020
• Supplement Dates Manufacturer Received: 01/07/2020
• Supplement Dates FDA Received: 03/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1