BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 1685916 · Received April 23, 2010

    Report

    Report Number
    1720753-2010-01228
    Event Type
    Malfunction
    Date Received
    April 23, 2010
    Date of Event
    March 26, 2010
    Report Date
    April 22, 2010
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE EVALUATED THE SYSTEM AND THE LOGS INDICATE THERE IS AN ATA2 CRC CHECKSUM ERROR, INDICATING A PROBLEM WITH THE COMMUNICATIONS BETWEEN THE SBC AND SATA DRIVE. THE DRIVE HAS BEEN REPLACED ON NUMEROUS OCCASIONS BEFORE AND IT WAS REPLACED AGAIN FOR THIS OCCURRENCE. ALSO THE BACKPLANE WAS REPLACED AND THE SATA CABLE (FROM SBC TO DRIVE. SBC (GPOS) WAS PREVIOUSLY REPLACED. SOFTWARE WAS RELOADED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE SYSTEM CRASHED DURING A PROCEDURE. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9900 C-ARM JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1