BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9600+

    MDR report key: 1018635 · Received March 24, 2008

    Report

    Report Number
    1720753-2008-19762
    Event Type
    Malfunction
    Date Received
    March 24, 2008
    Date of Event
    February 28, 2008
    Report Date
    March 19, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SERVICE REP CONFIRMED NO-BOOT ISSUE, MAIN FRAME NEVER LOCKED INTO BOOT SEQUENCE. FOUND 5VDC ON TECH PROC PCB AT 4.72VDC. TRACED BACK TO POOR CONTACT AT CIRCUIT BREAKER. CLEANED AND LUBRICATED CIRCUIT BREAKER CONTACTS AND REBOOTED SYSTEM TO FIND 5.10VDC ON TECH PROC PCB. SYSTEM BOOTED CORRECTLY 12 TIMES AFTER CONTACTS WERE CLEANED. DISCUSSED ISSUE WITH SECOND SHIFT SUPERVISOR "LIZ" AND HAD SYSTEM RE-BOOTED MULTIPLE TIMES OVER NIGHT. DISCUSSED ISSUE NEXT MORNING WITH CUSTOMER. CUSTOMER CONFIRMED SYSTEM BOOTED EVERYTIME ATTEMPTED THROUGH THE NIGHT AND AGAIN THIS MORNING. SYSTEM OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM WOULD NOT BOOT. ANOTHER SYSTEM WAS BROUGHT IN TO COMPLETE THE CASES. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9600+ FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1