BEUDAMED
    FDA Adverse Event Death Summary report: N

    STAT DL 9.5 FR. 40 CC. IAB

    MDR report key: 218022 · Received April 7, 1999

    Report

    Report Number
    2248146-1999-00015
    Event Type
    Death
    Date Received
    April 7, 1999
    Report Date
    March 18, 1999
    Manufacturer
    DATASCOPE CORPORATION
    Product Code
    DSP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED TO DATASCOPE ON 4/16/1999: THE PT WAS IAB DEPENDENT. THE BALLOON WAS INSERTED TRANSTHORACICALLY IN THE O.R. BLOOD WAS THEN NOTED IN TUBING. THE IAB WAS REMOVED. IT WAS REPORTED THAT AS A RESULT OF THE EVENT ON 3/13/1999, PT WENT ONTO EXPIRE ON 3/13/1999.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STAT DL 9.5 FR. 40 CC. IAB INTRA-AORTIC BALLOON CATHETER DSP DATASCOPE CORPORATION 0684-00-0306 01/28/01

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death