BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS100

    MDR report key: 4030626 · Received July 29, 2014

    Report

    Report Number
    2249723-2014-01075
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Date of Event
    October 24, 2011
    Report Date
    October 24, 2011
    Manufacturer
    DATASCOPE CORP.,
    Product Code
    DSP
    PMA / PMN Number
    K031636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP OBSERVED THAT THE SCREEN INTERMITTENTLY DOES NOT COME UP. THE COMPANY REP FOUND MAIN BOARD ERROR CODES 5 (ACROTIC DRIVER FAULT) THAT OCCURRED 153 TIMES AND 20 (COMM FAULT) THAT OCCURRED 50 TIMES. THE COMPANY REP REPLACED THE MAIN CPU BOARD (PART NUMBER 0670-00-0799E). THE COMPANY REP PERFORMED PERFORMANCE TESTS AND SAFETY CHECKS. THE UNIT MET FACTORY SPECIFICATIONS AND WAS RETURNED TO THE CUSTOMER. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A ROUTINE CHECK OF THE UNIT, ON POWER UP, THE DISPLAY WAS BLUE. NO PT WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442743 CS100 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP., CS100

    Patients

    Seq Age Sex Outcome Treatment
    1