BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS100

    MDR report key: 1637500 · Received March 12, 2010

    Report

    Report Number
    2249723-2006-00001
    Event Type
    Malfunction
    Date Received
    March 12, 2010
    Report Date
    November 20, 2006
    Manufacturer
    DATASCOPE CORP
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATASCOPE SERVICE TECH REPLACED THE DEFECTIVE LINE CORD. FUNCTIONAL AND SAFETY TESTS WERE SUCCESSFULLY COMPLETED. WE WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    END USER NOTED SMOKE COMING FROM THE AC LINE CORD. THIS IS BEING REPORTED IN RESPONSE TO THE FDA SAFETY INVESTIGATION (OCT 19, 2009).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CS100 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP CS100

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK