BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRILLIANCE 64-SLICE CT

    MDR report key: 17537121 · Received August 12, 2023

    Report

    Report Number
    MW5144001
    Event Type
    Injury
    Date Received
    August 12, 2023
    Date of Event
    July 14, 2014
    Report Date
    August 13, 2014
    Manufacturer
    PHILIPS
    Product Code
    JAK
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THIS IS TO INFORM YOU THAT GE HEALTHCARE RECEIVED A COMPLAINT FROM (B)(6) HOSPITAL, IN (B)(6), WHERE A GE SERVICE EMPLOYEE WAS REPORTED TO HAVE SUSTAINED A BROKEN FINGER WHILE SERVICING A PHILIPS CT SYSTEM ON (B)(6) 2014. IT WAS CONFIRMED THAT THERE WAS NO GE HEALTHCARE SYSTEM INVOLVED THAT CAUSED OR CONTRIBUTED TO THE EVENT. IT WAS ALSO REPORTED THAT THERE WAS POTENTIALLY A FAILURE OF THE PHILIPS BRILLIANCE 64-SLICE CT DURING THAT EVENT. THE CT SYSTEM INVOLVED IS NOT MANUFACTURED, IMPORTED NOR DISTRIBUTED BY GE HEALTHCARE. COMMUNICATION WAS RECEIVED FROM THE OEM, ON 5AUG2014, FROM (B)(6) (CT QUALITY AFFAIRS POST-MARKET SURVEILLANCE REPORTABLE COMPLAINT INVESTIGATOR; PHILIPS HEALTHCARE) INDICATING SHE WAS AWARE OF THE EVENT. (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1216921 BRILLIANCE 64-SLICE CT SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED JAK PHILIPS

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown