BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAT DL 9.5 FR. 40 CC. IAB

    MDR report key: 189912 · Received September 29, 1998

    Report

    Report Number
    2248146-1998-01114
    Event Type
    Malfunction
    Date Received
    September 29, 1998
    Date of Event
    September 24, 1998
    Report Date
    September 24, 1998
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE IAB LEAKED DURING INSERTION. IABP CONTINUED WITHOUT FURTHER PROBLEMS. THE IAB WAS USED AND WILL NOT BE RETURNED FOR EVALUATION. (EVENT COMPLICATIONS; NONE FROM THE EVENT - REPORTED 09/24/1998.) (PT'S CURRENT STATUS: UNK - REPORTED 09/24/1998.)

    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. 0684-00-0283 07/26/00

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN