BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAT DL 9.5 FR. 34 CC. IAB

    MDR report key: 188347 · Received September 16, 1998

    Report

    Report Number
    2248146-1998-01052
    Event Type
    Malfunction
    Date Received
    September 16, 1998
    Date of Event
    August 14, 1998
    Report Date
    September 8, 1998
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AFTER IABP FOR TWO DAYS, THE IAB LEAKED. BLOOD WAS NOTED IN THE CATHETER. THE IAB WAS NOT RETURNED TO DATASCOPE. THE IAB WAS DISCARDED BY THE FACILITY. EVENT COMPLICATIONS: NONE FROM THE EVENT - REPORTED 09/08/1998. PT'S CURRENT STATUS; UNK - RPT'D 09/08/1998.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STAT DL 9.5 FR. 34 CC. IAB INTRA-AORTIC BALLOON CATHETER DSP DATASCOPE CORP. 0784-00-0115 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN