MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. BRIGHTVIEW XCT; SYSTEM, TOMOGRAPHY, COMPUTED, EMISSION

Catalog Number 882482

Device Problem Mechanical Problem (1384)

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

Event Type  malfunction  

Manufacturer Narrative

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.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 pr# (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 table continued movement even though the touch panel was no longer pressed.The system was in clinical use.The patient was removed from the table in a controlled fashion.There was no report of harm.This malfunction may not 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.Therefore, this complaint is considered to be a reportable event to the regulatory agency per (b)(4) adverse event reporting procedure (ct/nm).This issue is not a reportable radiation event per (b)(4) ct/ami radiation event reporting.

Manufacturer Narrative

The customer reported the virtual hand controller on the touchscreen was used for patient positioning.The touchscreen command was released and the table continued to move until it reached its hard limit.The patient was removed from the system.The system was rebooted and returned to clinical use.A philips field service engineer (fse) went to the site to evaluate the system.The fse was not able to reproduce the issue.There was no patient injury, and the patient was removed from system.Data was sent to philips engineering and no probable cause was found.The probable cause is unknown at this time.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: BRIGHTVIEW XCT
• Type of Device: SYSTEM, TOMOGRAPHY, COMPUTED, EMISSION
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.; 595 miner rd; cleveland OH 44143
• MDR Report Key: 9364872
• MDR Text Key: 199861026
• Report Number: 1525965-2019-00070
• Device Sequence Number: 1
• Product Code: KPS
• Combination Product (y/n): N
• PMA/PMN Number: K080927
• 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: 11/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 882482
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1