BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRA-AORTIC BALLOON CATHETER

    MDR report key: 159564 · Received March 23, 1998

    Report

    Report Number
    2248146-1998-00321
    Event Type
    Malfunction
    Date Received
    March 23, 1998
    Date of Event
    March 11, 1998
    Report Date
    March 13, 1998
    Manufacturer
    DATASCOPE CORP
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE IAB LEAKED INTO THE SYSTEM 97 PUMP. THE IAB WAS REMOVED AND A SECOND IAB WAS INSERTED INTO THE PT. THE IAB WAS NOT RETURNED TO DATASCOPE FOR EVALUATION. THE IAB WAS DISCARDED BY THE FACILITY. (EVENT COMPLICATIONS: NONE FROM THE EVENT - REPORTED 3/13/1998.) (PT'S CURRENT STATUS: UNK - RPT'D 3/13/1998.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRA-AORTIC BALLOON CATHETER INTRA-AORTIC BALLOON CATHETER DSP DATASCOPE CORP UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN