BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 2152522 · Received June 27, 2011

    Report

    Report Number
    1720753-2011-08558
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 27, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SVC REP EXPLAINED TO THE CUSTOMER THAT A PO NEEDS TO BE PROVIDED BEFORE ANY SVC WILL BE CONDUCTED. THE CUSTOMER EXPLAINED THAT A PO WILL BE PROVIDED AND THAT (S)HE WOULD BE CALLING BACK AT A LATER DATE FOR SVC. AT LAST REPORT, THE CUSTOMER HAD NOT CALLED BACK FOR SVC. NO FURTHER SVC INFO WAS PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM HAD INTERMITTENT POWER FAILURES OUTSIDE OF A CASE. NO PT INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1