BEUDAMED
    FDA Adverse Event Death Summary report: N

    DORNIER COMPACT DELTA LITHOTRIPTER

    MDR report key: 1021957 · Received March 31, 2008

    Report

    Report Number
    1037955-2008-00001
    Event Type
    Death
    Date Received
    March 31, 2008
    Date of Event
    March 20, 2008
    Report Date
    March 31, 2008
    Manufacturer
    DORNIER MEDTECH SYSTEMS GMBH
    Product Code
    LNS
    PMA / PMN Number
    P840008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS CHECKED BY TWO OF OUR SERVICE ENGINEERS WHO FOUND THAT THE MACHINE WAS OPERATING WITH MANUFACTURERS SPECIFICATIONS. WE ARE WORKING WITH THE SITE TO DETERMINE THAT PROTOCOL WAS USED TO TREAT THE PT.

    Description of Event or Problem · 1

    REPORTER CALLED VINCE ACERET (DORNIER MEDTECH AMERICA, INC.) TO HAVE ONE OF DORNIER MEDTECH AMERICAN'S ENGINEERS COME AND LOOK AT THE COMPACT DELTA BEING USED ON A LITHOTRIPSY ROUTE IN MICHIGAN. IT WAS LATER FOUND OUT THAT ONE OF THE PATIENTS TREATED IN 2008 SUFFERED COMPLICATIONS AS A RESULT OF THE LITHOTRIPSY TREATMENT AND LATER DIED AS A RESULT OF THE COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DORNIER COMPACT DELTA LITHOTRIPTER NONE LNS DORNIER MEDTECH SYSTEMS GMBH CD-424 CD-242

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death