BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS100

    MDR report key: 3915701 · Received June 12, 2014

    Report

    Report Number
    2249723-2014-00707
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Date of Event
    December 21, 2012
    Report Date
    December 21, 2012
    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 REPRESENTATIVE REPLACED THE POWER SUPPLY (PART NUMBER: 0014-00-0033E05). IN AN UNRELATED REPAIR THE ECG INPUT TO FRONT END CABLE (PART NUMBER: 0012-00-0976) AND 3.9 INCH/99MM CABLE TIE (PART NUMBER 0125-01-0001) WERE ALSO REPLACED. THE 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 PREVENTIVE MAINTENANCE, THE COMPANY REPRESENTATIVE OBSERVED THAT THE IABP BATTERY ICON ON DISPLAY IS BLANK WITH FULLY CHARGED BATTERY. BATTERY VOLTAGE DISPLAYED IN SERVICE DIAGNOSTIC IS .1V WHEN ACTUAL VOLTAGE IS 24V. NO PATIENT WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346797 CS100 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP CS100

    Patients

    Seq Age Sex Outcome Treatment
    1