BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CS300

    MDR report key: 3872069 · Received April 17, 2014

    Report

    Report Number
    2249723-2014-00372
    Event Type
    Injury
    Date Received
    April 17, 2014
    Date of Event
    August 6, 2012
    Report Date
    August 6, 2012
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K063525
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE CONFIRMED THE ELECTRICAL CODE #50 FAILURE, AND DURING TESTING OBSERVED ERROR CODE #53, SHUTTLE TRANSDUCER FAILURE AND AN OFFSET OF 38. HE IDENTIFIED A DEFECTIVE MOTOR CONTROL CIRCUIT (ERROR CODE #50) AND REPLACED THE MOTOR CONTROL BOARD (D671-00-0004) AND THIS CORRECTED THE FAILURE. HE ALSO REPLACED AND CALIBRATED THE SHUTTLE TRANSDUCER (ERROR CODE #53). THE COMPANY REPRESENTATIVE TESTED THE IABP TO FACTOR SPECIFICATION. THE IABP FUNCTIONED NORMALLY AND WAS RETURNED TO THE CUSTOMER. REF: (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT PRIOR TO USE ON A PATIENT THE IABP GENERATED "ELECTRICAL TEST FAILURE CODE #50" (MOTOR SPEED OUT OF SPECIFICATION) UPON POWER UP. THE IABP WAS REPLACED AND THERAPY WAS INITIATED. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234931 CS300 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP. CS300

    Patients

    Seq Age Sex Outcome Treatment
    1