BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BASE SYSTEM, ILLUMENA, NON-OEM

    MDR report key: 3193209 · Received June 25, 2013

    Report

    Report Number
    1518293-2013-00136
    Event Type
    Malfunction
    Date Received
    June 25, 2013
    Date of Event
    May 29, 2013
    Report Date
    June 25, 2013
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    DXT
    PMA / PMN Number
    K963071
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    PENDING INVESTIGATION. UPON RECEIPT OF INVESTIGATION, A MEDWATCH 3500A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FIELD SERVICE ENGINEER REPORTS DURING A PREVENTATIVE MAINTENANCE, THE FILL/EXPEL BAR IS MOVED TO FILL POSITION, BUT THE RAM MOVES IN REVERSE DIRECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289040 BASE SYSTEM, ILLUMENA, NON-OEM DXT LIEBEL-FLARSHEIM CO. ILLUMENA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK