BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300

    MDR report key: 4001766 · Received June 30, 2014

    Report

    Report Number
    2249723-2014-00740
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    December 27, 2011
    Report Date
    January 6, 2012
    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 REPRESENTATIVE REPLACED THE PCB MOTOR CONTROLLER (PART NUMBER: 0671-00-0004). IN AN UNRELATED REPAIR THE BATTERIES 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 GENERATED AN "ELECTRICAL TEST FAILS CODE #50" (MOTOR SPEED OUT OF SPECIFICATION). 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
    381371 CS300 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP., CS300

    Patients

    Seq Age Sex Outcome Treatment
    1