BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS100

    MDR report key: 4122491 · Received September 22, 2014

    Report

    Report Number
    2249723-2014-01377
    Event Type
    Malfunction
    Date Received
    September 22, 2014
    Date of Event
    January 10, 2013
    Report Date
    January 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 REP TESTED THE UNIT AND COULD NOT DUPLICATE THE PROBLEM. OBSERVED THE FAULT LOG FOR THE ELECTRICAL TEST CODE #53 AND FAULT CODE #65. ISOLATED THE FAILURE TO DEFECTIVE K6A SOLENOID VALVE. THE COMPANY REP REPLACED THE K6A VENT VALVE (PART # 0119-00-0170) AND THE CLAMP CABLE (PART # 0343-05-0002). THE IABP WAS TESTED TO FACTORY SPEC. 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 PT, THE IABP GENERATED AN "ELECTRICAL TEST FAILURE CODE" TWO TIMES. THE PT WAS SWITCHED TO ANOTHER IABP AND THERAPY WAS CONTINUED. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587510 CS100 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP CS100

    Patients

    Seq Age Sex Outcome Treatment
    1