BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS100

    MDR report key: 4122485 · Received September 22, 2014

    Report

    Report Number
    2249723-2014-01383
    Event Type
    Malfunction
    Date Received
    September 22, 2014
    Date of Event
    January 18, 2013
    Report Date
    January 21, 2013
    Manufacturer
    DATASCOPE CORP
    Product Code
    DSP
    PMA / PMN Number
    K031636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP REPLACED THE VIDEO RECEIVER BOARD (B)(4). TH IABP WAS TESTED TO FACTORY SPECIFICATION. IT FUNCTIONED NORMALLY AND WAS RETURNED TO THE CUSTOMER. (B)(4).

    Description of Event or Problem · 1

    DURING A ROUTINE CHECK OF THE IABP, THE CUSTOMER OBSERVED DISTORTED INFO ON THE SCREEN. NO PT WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587509 CS100 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP CS100

    Patients

    Seq Age Sex Outcome Treatment
    1