BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAT DL 9.5 FR. 40 CC. IAB

    MDR report key: 180728 · Received August 1, 1998

    Report

    Report Number
    2248146-1998-00855
    Event Type
    Malfunction
    Date Received
    August 1, 1998
    Date of Event
    July 13, 1998
    Report Date
    July 21, 1998
    Manufacturer
    DATASCOPE CORP
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE "CATH ALARMS" SOUNDED FROM THE PUMP. BLOOD WAS NOTED IN THE TUBING AND THE IAB WAS REMOVED. 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: UNKNOWN - REPORTED 7/21/1998.) (PT'S CURRENT STATUS: UNK - RPT'D 7/21/1998.)

    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 UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN