BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 3931192 · Received June 18, 2014

    Report

    Report Number
    3931192
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    June 6, 2014
    Report Date
    June 18, 2014
    Manufacturer
    MAQUET DATASCOPE CORP - CARDIAC ASSIST DIVISION
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS PLACED ON INTRA-AORTIC BALLOON PUMP (IABP) CE#92470 AND PUMPING STARTED. AFTER 5 MINUTES, THE PUMP STOPPED SHUTTLING GAS AND THE ALARM STATED ON THE MONITOR "SYSTEM FAILURE". THE ELECTROCARDIOGRAM (ECG) AND PRESSURE MONITORING WERE BOTH STILL VISIBLE ON THE MONITOR. THE IABP WOULD NOT ALLOW THEM TO SILENCE THE ALARM, RESTART THE PUMP, OR TO ACCESS THE HELP MENU. THEY TOOK THE IABP FROM THE CATHETERIZATION LAB AND EXCHANGED THE EQUIPMENT WITH NO HARM TO THE PATIENT OR FURTHER COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358919 * SYSTEM, BALLON, INTRA-AORTIC AND CONTROL DSP MAQUET DATASCOPE CORP - CARDIAC ASSIST DIVISION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR