BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3802097 · Received December 30, 2013

    Report

    Report Number
    1720753-2013-13889
    Event Type
    Malfunction
    Date Received
    December 30, 2013
    Date of Event
    December 12, 2013
    Report Date
    December 30, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE PS1 AND PS2 POWER SUPPLIES, HARDWARE BRACKETS, PASSIVE BACKPLANE AND RTOS AND VCSI PCBS WERE EVALUATED AND REPLACED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND RETURNED TO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM WOULD NOT BOOT UP. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THE EVENT DESCRIBED IN THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679794 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1