BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAT DL 9.5 FR. 40 CC IAB

    MDR report key: 151504 · Received February 20, 1998

    Report

    Report Number
    2248146-1998-00185
    Event Type
    Malfunction
    Date Received
    February 20, 1998
    Date of Event
    November 27, 1997
    Report Date
    February 11, 1998
    Manufacturer
    DATASCOPE CORPORATION
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE IAB WAS INSERTED INTO THE PATIENT ON 11/25/1997. ON 11/27/1997, THE IAB LEAKED. BLOOD WAS NOTED. EVENT COMPLICATIONS: NONE FROM THE EVENT - REPORTED 2/11/1998. PT'S CURRENT STATUS: EXPIRED-RPT'S 2/11/1998.

    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 0684-00-0321 05/01/99

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR