BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HFX-PLUS

    MDR report key: 398998 · Received June 6, 2002

    Report

    Report Number
    1418957-2002-00001
    Event Type
    Malfunction
    Date Received
    June 6, 2002
    Date of Event
    May 7, 2002
    Report Date
    June 1, 2002
    Manufacturer
    FISCHER IMAGING CORP
    Product Code
    IZO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    NOT ENOUGH RESISTANCE TO THE COMPRESSION PADDLE DURING DOWNWARD MOVEMENT. DURING ONE INSTANCE, MAMMOGRAPHER WAS DOING MLO AND COMPRESSION PADDLE SLIPPED AND FELL. NO INJURY. DURING ANOTHER INSTANCE, PT RAISED ARM AND TOUCHED THE COMPRESSION PADDLE AND PADDLE SWUNG DOWN AND LANDED ON MAMMOGRAPHER'S HAND WHICH WAS ON THE BUCKY. NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HFX-PLUS X-RAY EQUIPMENT IZO FISCHER IMAGING CORP HFX-PLUS *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other