BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAMMOTEST PLUS

    MDR report key: 493087 · Received October 28, 2003

    Report

    Report Number
    1418957-2003-00003
    Event Type
    Malfunction
    Date Received
    October 28, 2003
    Date of Event
    October 16, 2003
    Report Date
    October 27, 2003
    Manufacturer
    FISCHER IMAGING CORP
    Product Code
    IZH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    TUBE ARM SHAFT BROKE OVERNIGHT WHILE FACILITY WAS CLOSED. FSE WAS NOTIFIED OF INOPERABLE GAS PISTON IN 2003 AND SCHEDULED REPAIR VISIT FOUR DAYS LATER. ON TROUBLESHOOTING IT WAS FOUND THAT PART NUMBER 71934 WAS BROKEN AT TOP OF SHAFT. HAD THIS OCCURRED DURING A BIOPSY PROCEDURE PT INJURY MAY HAVE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAMMOTEST PLUS BREAST BIOPSY SYSTEM IZH FISCHER IMAGING CORP MAMMOTEST PLUS *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other