BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300

    MDR report key: 4213087 · Received August 4, 2014

    Report

    Report Number
    2249723-2014-01026
    Event Type
    Malfunction
    Date Received
    August 4, 2014
    Date of Event
    September 8, 2011
    Report Date
    September 8, 2011
    Manufacturer
    DATASCOPE CORP
    Product Code
    DSP
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP VERIFIED THE PROBLEM AND OBSERVED BROKEN CLIPS INSIDE THE MODULE CONNECTOR. THE FIBER OPTIC MODULE ( PART NUMBER 0997-00-1161) WAS REPLACED. THE COMPANY REP PERFORMED PERFORMANCE AND FUNCTIONAL TESTS. THE UNIT MET FACTORY SPECIFICATIONS AND WAS RETURNED TO THE CUSTOMER. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT PRIOR TO USE ON A PATIENT THE UNIT WOULD NOT HOLD THE CATHETER FIBER OPTIC CONNECTOR IN PLACE. THE PUMP WAS REPLACED AND THERAPY WAS INITIATED. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455614 CS300 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP CS300

    Patients

    Seq Age Sex Outcome Treatment
    1