BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS100

    MDR report key: 3950717 · Received June 6, 2014

    Report

    Report Number
    2249723-2014-00863
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    November 8, 2013
    Report Date
    November 8, 2013
    Manufacturer
    DATASCOPE CORP
    Product Code
    DSP
    PMA / PMN Number
    K031636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD (DHR) FOR THE IABP INVOLVED IN THE EVENT WAS REVIEWED. THERE WERE NO NON-CONFORMANCES IN THE DHR RELATED TO THE REPORTED EVENT. THE COMP REP OBSERVED THAT THE IABP FAILED TO CALIBRATE TO THE IAB. THE COMP REP REPLACED THE FIBER OPTIC ASSEMBLY (PART NO: 0997-00-1161E) AND THE LUER FITTING. THE IABP WAS TESTED TO FACTORY SPECIFICATIONS. IT FUNCTIONED NORMALLY AND WAS RETURNED TO THE CUSTOMER. THE FIBER OPTIC ASSEMBLY REPLACED WILL BE SENT TO THE MANUFACTURING FACILITY AT (B)(4) FOR EVAL. A SUPPLEMENTAL MDR WILL BE SUBMITTED WHEN ADD'L INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT PRIOR TO USE ON A PT, THE IABP FAILED CALIBRATE THE FIBER OPTIC. THE IABP WAS REPLACED AND THERAPY WAS INITIATED. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331681 CS100 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP CS100

    Patients

    Seq Age Sex Outcome Treatment
    1