BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAT DL 9.5 FR. 40 CC. IAB

    MDR report key: 176841 · Received July 10, 1998

    Report

    Report Number
    2248146-1998-00743
    Event Type
    Malfunction
    Date Received
    July 10, 1998
    Date of Event
    June 23, 1998
    Report Date
    June 24, 1998
    Manufacturer
    DATASCOPE CORP
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE IAB LEAKED. THIS WAS THE ONLY INFO AT THE TIME OF THE REPORT. THE IAB WAS NOT RETURNED TO DATASCOPE FOR EVALUATION. THE IAB WAS DISCARDED BY THE FACILITY. (EVENT COMPLICATIONS: UNKNOWN - REPORTED 6/24/1998.) (PT'S CURRENT STATUS: UNK - REPORTED 6/24/1998.)

    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