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

Model Number 2170-3000A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Type  malfunction  

Event Description

This complaint has been evaluated based on the information provided; there is no allegation of death or serious injury.The customer reported that the system continued to move after the button on the remote hand control was released.Based on additional information from field safety notice (fsn) 88200521/ hhe ami 1123-2019 it has been determined this record is a reportable event.A field safety notice (fsn) has been released to customers indicating that an issue has been found with the hand controller for the brightview family of cameras.The issue results in either spontaneous uncommanded (not initiated by the operator) motions or continued motion after the buttons were released.

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.

• Brand Name: BRIGHTVIEW SPECT
• Type of Device: SYSTEM, TOMOGRAPHY, COMPUTED, EMISSION
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.; 595 miner rd; cleveland OH 44143
• MDR Report Key: 8792996
• MDR Text Key: 209399158
• Report Number: 1525965-2019-00030
• Device Sequence Number: 1
• Product Code: KPS
• Combination Product (y/n): N
• PMA/PMN Number: K062298
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 05/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2170-3000A
• Device Catalogue Number: 882480
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 1525965-06/11/2019-002-C
• Patient Sequence Number: 1