BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300

    MDR report key: 4122449 · Received September 22, 2014

    Report

    Report Number
    2249723-2014-01389
    Event Type
    Malfunction
    Date Received
    September 22, 2014
    Date of Event
    January 3, 2013
    Report Date
    January 4, 2013
    Manufacturer
    DATASCOPE CORP
    Product Code
    DSP
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP REPLACED THE VENT VALVE (PART # 0119-00-0170) AND DRIVE MANIFOLD (PART # 0104-00-0018). 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 #58" ALARM (POWER-UP VENT TEST FAILED). THE IABP WAS REPLACED AND THERAPY WAS INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587505 CS300 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP CS300

    Patients

    Seq Age Sex Outcome Treatment
    1