BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3192196 · Received June 20, 2013

    Report

    Report Number
    1720753-2013-07391
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Date of Event
    June 12, 2013
    Report Date
    May 20, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SVC REP PERFORMED AN ON SITE INVESTIGATION. THE BATTERY PACK WAS REPLACED AND CONNECTORS WERE RESEATED DURING THE SVC CALL. THE SYS WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SVC.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THERE WAS A PRECHARGE VOLTAGE ERROR. THIS ERROR WILL LIKELY PREVENT THE SYS 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
    280257 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1