BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CS300

    MDR report key: 3872045 · Received April 17, 2014

    Report

    Report Number
    2249723-2014-00403
    Event Type
    Injury
    Date Received
    April 17, 2014
    Date of Event
    August 13, 2012
    Report Date
    August 13, 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 OBSERVED THE FAILURE REPORTED BY CUSTOMER. THE COMPANY REPRESENTATIVE REPAIRED THE CABLE TO THE MOTOR CONTROL BOARD AND THE MOTOR COMPARTMENT, AND ALSO REPLACED THE MOTOR CONTROL BOARD CIRCUIT (PART NUMBER 0671-00-0004) THE IABP WAS TESTED TO FACTORY SPECIFICATION. IT FUNCTIONED NORMALLY AND WAS RETURNED TO THE CUSTOMER. INTERNAL FILE: (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT PRIOR TO USE ON A PATIENT, THE IABP GENERATED ALARM "ELECTRICAL TEST FAILURE CODE #51" (ADJUSTED MOTOR SPEED OUT SPECIFICATION). THE IABP WAS REPLACED AND THERAPY WAS INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235143 CS300 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP. CS300

    Patients

    Seq Age Sex Outcome Treatment
    1