BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3172163 · Received June 11, 2013

    Report

    Report Number
    1720753-2013-06955
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    February 27, 2013
    Report Date
    June 11, 2013
    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

    NO CONCLUSION CAN BE DRAWN AS REPAIR INFORMATION WAS NOT REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A PRECHARGE VOLTAGE ERROR. THIS ERROR WILL LIKELY PREVENT THE SYSTEM FROM BOOTING. 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
    263499 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1