BEUDAMED
    FDA Adverse Event Other Summary report: N

    INTRA-AORTIC BALLOON PUMP

    MDR report key: 16143 · Received September 15, 1994

    Report

    Report Number
    MW1003368
    Event Type
    Other
    Date Received
    September 15, 1994
    Date of Event
    August 10, 1994
    Report Date
    August 20, 1994
    Manufacturer
    KONTRON INSTRUMENTS, INC.
    Product Code
    DSP
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAD IABP PLACED IN CV LAB. BALLOON PUMP FUNCTIONED X15 MINUTES, AFTER WHICH IT READ, "PURGE FAILURE," AND WAS THEN NON-FUNCTIONAL. IABP IMMEDIATELY SWITCHED TO ANOTHER PUMP AND BIOMED IS INVESTIGATING THE MALFUNCTIONING IABP. MFR HAS BEEN NOTIFIED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other