BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C-ARM

    MDR report key: 1842288 · Received August 27, 2010

    Report

    Report Number
    9680959-2010-00309
    Event Type
    Malfunction
    Date Received
    August 27, 2010
    Date of Event
    December 17, 2009
    Report Date
    August 27, 2010
    Manufacturer
    GE OEC MEDICAL SYSTEMS GMBH
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPAIRS ON THIS SYSTEM WERE NOT DISCLOSED. THE COMPLAINT DOES INDICATE PHONE SUPPORT WAS PERFORMED. NO CONCLUSION CAN BE DRAWN. HOWEVER, NO REPORTS OF PATIENT OR STAFF INJURY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM WAS HUNG UP. NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C-ARM FLUOROSCOPY XRAY JAA GE OEC MEDICAL SYSTEMS GMBH 7900

    Patients

    Seq Age Sex Outcome Treatment
    1