BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 4142942 · Received September 12, 2014

    Report

    Report Number
    1720753-2014-07883
    Event Type
    Malfunction
    Date Received
    September 12, 2014
    Date of Event
    August 7, 2014
    Report Date
    September 12, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE HARD DRIVE AND THE SOFTWARE WERE INSTALLED DURING THE SERVICE CALL. THE SYSTEM WAS WAITING ON ADDITIONAL PARTS AND WAS NOT OPERATIONAL.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYS WOULD NOT BOOT UP. THIS RESULTED IN A TOTAL LOSS OF IMAGING FUNCTIONALITY. THIS COULD CAUSE THE DELAY OR CANCELLATION OF A PROCEDURE. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Additional Manufacturer Narrative · 2

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE HARD DRIVE AND THE SOFTWARE WERE INSTALLED DURING THE SERVICE CALL. THE SYSTEM WAS WAITING ON ADD'L PARTS AND WAS NOT OPERATIONAL.

    Description of Event or Problem · 2

    THE CUSTOMER REPORTED THAT THE SYS WOULD NOT BOOT UP. THIS RESULTED IN A TOTAL LOSS OF IMAGING FUNCTIONALITY. THIS COULD CAUSE THE DELAY OR CANCELLATION OF A PROCEDURE. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565396 8800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 8800

    Patients

    Seq Age Sex Outcome Treatment
    1
    2