BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CS300

    MDR report key: 3872060 · Received April 17, 2014

    Report

    Report Number
    2249723-2014-00416
    Event Type
    Injury
    Date Received
    April 17, 2014
    Date of Event
    September 17, 2013
    Report Date
    September 17, 2013
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K063525
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE OBSERVED "AUTOFILL FAILURE" AND "ELECTRICAL TEST FAILURE CODE #58" (POWER-UP VENT TEST FAILURE) ALARMS IN THE FAULT LOG. HE DID NOT OBSERVE ANY MAINTENANCE CODE #3 IN THE FAULT LOG. HE CLEARED EXCESSIVE MOISTURE FROM THE PURGE LINE. THE COMPANY REPRESENTATIVE REPLACED THE TUBING ASSEMBLY FILTER (PART NUMBER 0008-00-0331) AND THE MANIFOLD DRIVE (0997-00-0985-0018), IN AN UNRELATED REPAIR THE SAFETY DISK (0997-00-0985-01 ) AND THE BATTERIES (0146-00-0039) 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

    THE CUSTOMER REPORTED THAT WHILE THE IABP WAS IN USE ON A PATIENT, THE IABP DISPLAYED "MAINTENANCE CODE #3 (BALLOON TRANSDUCER OFFSET FAILURE) ON THE SCREEN. WHILE ATTEMPTING TO TROUBLESHOOT WITH THE CLINICAL REPRESENTATIVE THE IABP GENERATED AN "AUTOFILL FAILURE" ALARM. THE PATIENT WAS SWITCHED TO ANOTHER IABP AND THERAPY WAS CONTINUED . NO PATIENT INJURY WAS REPORTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234922 CS300 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP. CS300

    Patients

    Seq Age Sex Outcome Treatment
    1 Other