BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAD MICRO 80 HF

    MDR report key: 494763 · Received November 5, 2003

    Report

    Report Number
    1418957-2003-00004
    Event Type
    Malfunction
    Date Received
    November 5, 2003
    Date of Event
    September 24, 2003
    Report Date
    October 31, 2003
    Manufacturer
    FISCHER IMAGING CORP.
    Product Code
    IYB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    AFTER COMPLETING THE NECESSARY VIEWS ON THE PATIENT ABNORMAL NOISES WERE HEARD COMING FROM THE PRODUCT AND SHORTLY THEREAFTER SMOKE WAS SEEN COMING FROM THE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RAD MICRO 80 HF X-RAY MACHINE IYB FISCHER IMAGING CORP. RAD MICRO 80 HF *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other