BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300

    MDR report key: 3874832 · Received April 25, 2014

    Report

    Report Number
    2249723-2014-00300
    Event Type
    Malfunction
    Date Received
    April 25, 2014
    Date of Event
    July 28, 2013
    Report Date
    July 28, 2013
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPANY REP (FIELD SERVICE ENGINEER) REPLACED THE MANIFOLD DR (D104-00-0018). THE IABP WAS TESTED TO FACTORY SPECIFICATIONS. IT FUNCTIONED NORMALLY AND IT WAS RETURNED TO THE CUSTOMER. THE COMPANY EVALUATED THE REPLACED DRIVE MANIFOLD (P/N0104-00-0018) BY PLACING THE DISCREPANT PART INTO A CS100 TEST FIXTURE. THE K6 VALVE WAS ACTIVATED AND FAILED TO VENT THE VACUUM PRESSURE, I.E. FAILURE WAS CONFIRMED. THE COMPANY HAS ADDRESSED THE ROOT CAUSE OF THIS 'STICKY' K6 VALVE ISSUE IN CAPA (B)(4). THE DRIVE MANIFOLD IN THIS COMPLAINT WAS MANUFACTURED PRIOR TO IMPLEMENTATION OF (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE THE IABP WAS IN USE ON A PT, THE IABP GENERATED A MAINTENANCE REQUIRED CODE #2 (DRIVE TRANSDUCER OFFSET FAILURE) ALARM. AFTER REBOOTING THE IABP), THE CUSTOMER REPORTED THAT THE IABP GENERATED AN ELECTRICAL TESTING FAILURE CODE #58 (POWER-UP VENT TEST FAILURE) ALARM. 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
    250513 CS300 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP. CS300

    Patients

    Seq Age Sex Outcome Treatment
    1