BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300

    MDR report key: 4122451 · Received September 22, 2014

    Report

    Report Number
    2249723-2014-01379
    Event Type
    Malfunction
    Date Received
    September 22, 2014
    Date of Event
    January 22, 2013
    Report Date
    January 22, 2013
    Manufacturer
    DATASCOPE CORP
    Product Code
    DSP
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP TESTED THE UNIT AND COULD NOT DUPLICATE THE REPORTED EVENT ON POWER UP. HE OBSERVED THE ELECTRICAL CODE FAILURE #42 IN FAULT LOG. THE COMPANY REP REPLACED THE DATASETTE IAB CS300 (PART #: 0670-00-0786) AND THE DATASETTE DSS CS300 (PART #: 0670-00-0787) WHICH WERE CAUSING COMPATIBILITY FAILURE TO FRONT END ON POWER UP. 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 PRIOR TO USE ON A PT THE IABP GENERATED "ELECTRICAL TEST FAILURE CODE #42" (IABP (6809) DATASETTE NOT COMPATIBLE WITH FRONT END HC11). THE IABP WAS REPLACED AND THERAPY WAS INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587485 CS300 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP CS300

    Patients

    Seq Age Sex Outcome Treatment
    1