BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 1800071 · Received August 11, 2010

    Report

    Report Number
    1720753-2010-02438
    Event Type
    Malfunction
    Date Received
    August 11, 2010
    Date of Event
    July 19, 2010
    Report Date
    August 11, 2010
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER ADJUSTED THE MONITOR POWER SUPPLY FROM 11.86 TO 12.2 VDC, AND INDICATED THE SYSTEM IS FUNCTIONING. CANCELLED CASE DUE TO DELAY IN FSE AVAILABILITY. CUSTOMER WILL MONITOR SYSTEM.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE LEFT MONITOR IS OUT INSIDE A PROCEDURE. 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