BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAMMOTEST

    MDR report key: 1361155 · Received January 29, 2009

    Report

    Report Number
    2240869-2009-00001
    Event Type
    Malfunction
    Date Received
    January 29, 2009
    Date of Event
    December 12, 2008
    Report Date
    January 14, 2009
    Manufacturer
    SIEMENS AG
    Product Code
    IZH
    PMA / PMN Number
    K042095
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AS A PREVENTATIVE MEASURE, LOCKING BLOCKS OF LATERAL ARM AND ATTACHMENT PINS ON WHICH LATERAL ARM ENGAGES, HAVE BEEN REPLACED AND SENT BACK TO THE MANUFACTURER FOR FURTHER INVESTIGATION. THE SYSTEM WAS REPLACED AT THIS SITE. INCIDENT OCCURRED AT: (B)(6).

    Description of Event or Problem · 1

    INCIDENT IN FRANCE: DURING A PROCEDURE, THE LATERAL ARM THAT SUPPORTS THE AUTOGUIDE (B)(4), DISENGAGED AND THE AUTOGUIDE FELL DOWN. THE AUTOGUIDE IS THE DEVICE THAT POSITIONS THE NEEDLE HOLDER OR BIOPSY DEVICE USED TO PLACE A BIOPSY NEEDED AT THE SITE OF THE LESION. THE AUTOGUIDE DID NOT FALL DOWN ON THE FLOOR BECAUSE IT WAS STOPPED BY THE POWER SUPPLY/CONTROL CABLE. THE NEEDLE FELL TO THE FLOOR AND WAS DAMAGED. THERE WAS NO REPORTED INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAMMOTEST SYSTEM, XRAY, MAMMOGRAPHIC IZH SIEMENS AG 10144750

    Patients

    Seq Age Sex Outcome Treatment
    1