BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRA-AORTIC BALLOON CATHETER

    MDR report key: 56450 · Received December 11, 1996

    Report

    Report Number
    2248146-1996-00363
    Event Type
    Malfunction
    Date Received
    December 11, 1996
    Date of Event
    July 26, 1995
    Report Date
    November 11, 1996
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED TO CO ON 11/11/96 VIA THE VOLUNTARY MEDWATCH FROM THE FDA (MDR ACCESS NUMBER: 4001668). THE IABP ALARMED "BLOOD DETECTED IN CATHETER: AND THE BALLOON WAS REMOVED. A SECOND WAS INSERTED INTO THE PT. THERE WERE NO COMPLICATIONS REPORTED RFORM THE EVENT. EVENT COMPLICATIONS: NONE FROM THE EVENT -REPORTED 11/11/96. PT'S CURRENT STATUS: UNK -REPORTED 11/11/96.

    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