BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300

    MDR report key: 4213088 · Received August 4, 2014

    Report

    Report Number
    2249723-2014-01137
    Event Type
    Malfunction
    Date Received
    August 4, 2014
    Date of Event
    December 13, 2011
    Report Date
    December 13, 2011
    Manufacturer
    DATASCOPE CORP
    Product Code
    DSP
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP FOUND SEVERAL ELECTRICAL TEST FAIL CODE #53 ERROR MESSAGES ON THE ERROR LOG. THE COMPANY REP OBSERVED IN THE PNEUMATIC PERFORMANCE SCREEN, THE SHUTTLE AND ATMOSPHERE NUMBERS HAD XX'S NEXT TO THEM INDICATING THAT THE DRIVE TRANSDUCER IS NOT OPERATING. THE COMPANY REP REPLACED THE (PRESSURE) DRIVER TRANSDUCER ((B)(4)). THE COMPANY REP PERFORMED FUNCTIONAL TESTS AND LEAKAGE TESTS. THE COMPANY REP OBSERVED THE SAFETY DISK HAS EXPIRED AND NOTIFIED THE CUSTOMER. THE UNIT MET FACTORY SPECIFICATIONS AND WAS RETURNED TO THE CUSTOMER. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A ROUTINE CHECK OF THE UNIT, THE IABP GENERATED AN ELECTRICAL TEST FAILS CODE #53 ALARM (SHUTTLE TRANSDUCER OFFSET FAILURE). NO PATIENT WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455621 CS300 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP CS300

    Patients

    Seq Age Sex Outcome Treatment
    1