BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300

    MDR report key: 4122490 · Received September 22, 2014

    Report

    Report Number
    2249723-2014-01385
    Event Type
    Malfunction
    Date Received
    September 22, 2014
    Date of Event
    April 4, 2013
    Report Date
    April 5, 2013
    Manufacturer
    DATASCOPE CORP
    Product Code
    DSP
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP WAS UNABLE TO DUPLICATE THE REPORTED PROBLEM. HE OBSERVED AUTOFILL FAILURES AND BLOOD DETECTED CODES IN THE FAULT JOURNAL. AS A PRECAUTIONARY MEASURE, THE SOLENOID DRIVER BROAD WAS REPLACED (PART # 0670-00-0639E). 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 WHILE THE IABP WAS IN USE ONA PT, THEY RECEIVED A "BLOOD DETECTED" MESSAGE. THE CUSTOMER TRIED TO AUTOFILL AND RECEIVED "AUTOFILL FAILURE" AND MAINTENANCE REQUIRED CODE 3 (BALLOON TRANSDUCER OFFSET FAILURE)" MESSAGES. 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
    587611 CS300 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP CS300

    Patients

    Seq Age Sex Outcome Treatment
    1