BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C-ARM

    MDR report key: 1791381 · Received August 6, 2010

    Report

    Report Number
    9680959-2010-00252
    Event Type
    Malfunction
    Date Received
    August 6, 2010
    Date of Event
    February 16, 2010
    Report Date
    August 6, 2010
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT INDICATED THE GENERATOR NEEDED REPLACING. HOWEVER, THE CUSTOMER CANCELLED THE SERVICE CALL. NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM BECAME INOPERABLE. NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C-ARM FLUOROSCOPY XRAY JAA GE OEC MEDICAL SYSTEMS (SLC) 7700

    Patients

    Seq Age Sex Outcome Treatment
    1