BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS100

    MDR report key: 4109623 · Received September 10, 2014

    Report

    Report Number
    2249723-2014-01320
    Event Type
    Malfunction
    Date Received
    September 10, 2014
    Date of Event
    June 10, 2013
    Report Date
    June 10, 2013
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K031636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE OBSERVED GREEN ARTIFACT MOVING IN A VERTICAL DIRECTION FROM THE TOP TO THE BOTTOM OF THE SCREEN. HE REPLACED THE COILED CABLE (PART NUMBER 0012-00-0422) AND THE PCB COLOR VIDEO RECEIVER (PART NUMBER 0670-00-0736). 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 PATIENT, THE IABP SHOWED ARTIFACT ON THE SCREEN DURING POWER UP. THE IABP WAS REPLACED AND THERAPY WAS INITIATED. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    558994 CS100 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP. CS100

    Patients

    Seq Age Sex Outcome Treatment
    1