BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRA-AORTIC BALLOON

    MDR report key: 15094 · Received August 8, 1994

    Report

    Report Number
    MW1003038
    Event Type
    Injury
    Date Received
    August 8, 1994
    Manufacturer
    KONTRON INSTRUMENTS, INC.
    Product Code
    DSP
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    PT DEVELOPED A LEAK IN THE INTRA-AORTIC BALLOON. BLOOD WAS NOTED IN THE TUBING, AND THE CONSOLE WAS IMMEDIATELY TURNED OFF. THE BALLOON WAS DISCONTINUED SHORTLY AFTERWARDS. THE PT LOST PEDAL PULSES SHORTLY AFTERWARDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRA-AORTIC BALLOON INTRA-AORTIC BALLOON DSP KONTRON INSTRUMENTS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention