BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAT DL 9.5 FR.40 CC. IAB

    MDR report key: 186021 · Received September 2, 1998

    Report

    Report Number
    2248146-1998-01003
    Event Type
    Malfunction
    Date Received
    September 2, 1998
    Report Date
    August 21, 1998
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE IAB LEAKED. THE BALLOON WAS FULL OF BLOOD. (EVENT COMPLICATIONS: UNKNOWN - REPORTED 08/21/1998. (PT'S CURRENT STATUS: UNK - RPT'D 08/21/1998.)

    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 CORP. 0684-00-0306 05/13/00

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN