BEUDAMED
    FDA Adverse Event Death Summary report: N

    STAT DL 9.5 FR. 40 CC. IAB

    MDR report key: 147168 · Received January 28, 1998

    Report

    Report Number
    2248146-1998-00077
    Event Type
    Death
    Date Received
    January 28, 1998
    Date of Event
    January 23, 1998
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP MDR WAS MAILED TO THE FDA ON 2/24/98.

    Description of Event or Problem · 1

    ON 1/30/98, DATASCOPE RECEIVED THE MANDATORY MEDWATCH FORM FROM THE USER FACILITY; UF/DIST REPORT NUMBER: 230053-1998-0002 AND THE FOLLOWING INFORMATION WAS REPORTED: FOLLOWING A PROCEDURE TO REPAIR AN ASCENDING AORTIC ANUERYSM, THE PT WAS PUT ON AN INTRA-AORTIC BALLOON PUMP. THE STAFF NOTICED THAT THE PUMP HAD STOPPED WORKING. THE PUMP'S PANEL WAS OPENED AND IT WAS NOTED THAT THERE WAS A BLOOD BACK. THE INTRA-AORTIC BALLOON CATHETER AND PUMP WERE REPLACED. THE PT EXPIRED ABOUT 12 HOURS LATER ON 1/24/98. IT WAS INDICATED THAT THE PT'S DEATH WAS RELATED TO THE IAB EVENT. EVENT COMPLICATIONS: NONE FROM THE EVENT - REPORTED 1/23/98; DEATH REPORTED 1/30/98. PT'S CURRENT STATUS: EXPIRED - REPORTED 1/30/98.

    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 CORP. 0684-00-0283 10/30/99

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death