BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE

    MDR report key: 4109621 · Received September 10, 2014

    Report

    Report Number
    2249723-2014-01335
    Event Type
    Malfunction
    Date Received
    September 10, 2014
    Date of Event
    June 20, 2013
    Report Date
    June 21, 2013
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE OBSERVED THE FOLLOWING FAULT CODES ON THE DISPLAY FOR THE EXECUTIVE PROCESSOR BOARD: F7 BSP (INITIALIZATION FAULT) AND F0 WDT (RESET FAULT). THE COMPANY REPRESENTATIVE REPLACED THE EXECUTIVE PROCESSOR BOARD (PART NUMBER 0670-00-0770) AND THE FRONT END BOARD (PART NUMBER 0670-00-0769). IN AN UNRELATED THE IABP WAS TESTED TO FACTORY SPECIFICATION. IT FUNCTIONED NORMALLY AND WAS RETURNED TO THE CUSTOMER. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A ROUTINE CHECK OF THE IABP, AT START-UP THE SPINNING ICON ON THE TOUCHSCREEN BEGAN TO SPIN CLOCKWISE, THEN THE UNIT GENERATED A CONTINUOUS BEEPING TONE. THE IABP WAS REPLACED PRIOR TO USE ON A PATIENT. NO PATIENT WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559475 CARDIOSAVE INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP. CARDIOSAVE

    Patients

    Seq Age Sex Outcome Treatment
    1