BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 4850061 · Received June 12, 2015

    Report

    Report Number
    4850061
    Event Type
    Malfunction
    Date Received
    June 12, 2015
    Date of Event
    February 21, 2015
    Report Date
    June 12, 2015
    Manufacturer
    MAQUET DATASCOPE CORP - CARDIAC ASSIST DIVISION
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US

    Narratives

    Description of Event or Problem · 1

    PATIENT IS POST- ST SEGMENT ELEVATION MYOCARDIAL INFARCTION (STEMI). INTRA-AORTIC BALLOON PUMP (IABP) PLACED IN CATH. LAB PRIOR TO DECISION ON WHETHER TO PERFORM CABG. DURING PATIENT ADMISSION IN ICU POST IABP PLACEMENT IABP CONSOLE DISPLAYED "CODE 2 FAILURE" AND A MALFUNCTION ALARM SOUNDED. THE DEVICE STOPPED FUNCTIONING. THE IABP CONSOLE WAS REPLACED AND PATIENT REMAINED STABLE WITHOUT ANY COMPLICATION. OLD CONSOLE REMOVED FROM SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383996 * SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP MAQUET DATASCOPE CORP - CARDIAC ASSIST DIVISION CS300 *

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR