BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRA-AORTIC BALLOON PUMP

    MDR report key: 14807 · Received July 21, 1994

    Report

    Report Number
    MW1002908
    Event Type
    Injury
    Date Received
    July 21, 1994
    Date of Event
    July 1, 1994
    Report Date
    July 7, 1994
    Manufacturer
    KONTRON INSTRUMENTS, INC.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IABP INITIATED IN ICU. PUMPING AND WORKING WELL WITHOUT SIGNS OF FAILURE. IABP UNPLUGGED FOR TRANSPORTATION. PREP PANEL FLASHED BATTERY FAILURE AND INDICATED THERE WAS 10 MINUTES OF BATTERY LIFE AND IMMEDIATELY FAILED. PUMP PLUGGED BACK IN AND STARTED CHARGING. IABP LEFT PLUGGED IN AND CHARGING UNTIL ARRANGEMENTS WERE MADE FOR TRANSPORT, APPROX 20 MINUTES. TRANSPORT INITIATED, IABP FAILED AGAIN APPROX 10 TO 15 MINUTES INTO TRANSPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRA-AORTIC BALLOON PUMP INTRA-AORTIC BALLOON PUMP DSP KONTRON INSTRUMENTS, INC. K2000

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention