BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE

    MDR report key: 3915751 · Received June 12, 2014

    Report

    Report Number
    2249723-2014-00715
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Date of Event
    December 27, 2012
    Report Date
    December 27, 2012
    Manufacturer
    DATASCOPE CORP
    Product Code
    DSP
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE REPLACED THE MANIFOLD HELIUM FILL (PART NUMBER: 0104-00-0014), THE 300PSI CHECK VALVE (PART NUMBER: 0103-00-0634) AND HELIUM PRESSURE REGULATOR (0103-00-0442). THE COMPANY REPRESENTATIVE PERFORMED CALIBRATION CHECK, FUNCTIONAL TESTING AND SAFETY CHECK TO FACTORY SPECIFICATION. COMPLETED INSTALLATION AND RETURNED THE UNIT TO THE CUSTOMER. (B)(4).

    Description of Event or Problem · 1

    DURING INSTALLATION OF THE IABP, THE COMPANY REPRESENTATIVE OBSERVED THAT THE IABP FAILED BILL MANIFOLD LEAK TEST. NO PATIENT WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346742 CARDIOSAVE INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP CARDIOSAVE

    Patients

    Seq Age Sex Outcome Treatment
    1