BEUDAMED
    FDA Adverse Event Death Summary report: N

    JOSTRA HL-20

    MDR report key: 570311 · Received February 3, 2005

    Report

    Report Number
    8010762-2005-00010
    Event Type
    Death
    Date Received
    February 3, 2005
    Date of Event
    October 18, 2004
    Report Date
    January 26, 2005
    Manufacturer
    MAQUET CARDIOPULMONARY
    Product Code
    DTQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE POWER SUPPLY BOARD OF THE SYSTEM WAS BURNING DURING AN OPEN-HEART OPERATION. THE HEART LUNG MACHINE HAD TO BE EXCHANGED.

    Description of Event or Problem · 1

    THIS COMPLAINT WAS SUBMITTED WITH THE INCORRECT MANUFACTURING REPORT NUMBER. 8010762 SHOULD INFACT BE 8010042.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JOSTRA HL-20 HEART LUNG MACHINE DTQ MAQUET CARDIOPULMONARY 20-147 *

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Death