BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DATASCOPE

    MDR report key: 17733 · Received July 29, 1994

    Report

    Report Number
    17733
    Event Type
    Injury
    Date Received
    July 29, 1994
    Date of Event
    March 19, 1994
    Report Date
    May 16, 1994
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    INTRA-AORTIC BALLOON PUMP ALARMED INDICATING THERE WAS BLOOD IN THE TUBING AND WOULD NOT REFILL. THE BALLOON WAS REMOVED AT 8:15 AM ON MARCH 19, 1994.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DATASCOPE INTRA-AORTIC BALLOON DSP DATASCOPE CORP. 9.5 FR 40CC DL PEVCOR STAT UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization