BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300

    MDR report key: 3874775 · Received April 25, 2014

    Report

    Report Number
    2249723-2014-00476
    Event Type
    Malfunction
    Date Received
    April 25, 2014
    Date of Event
    September 4, 2012
    Report Date
    September 11, 2012
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER SAID THAT THERE WAS A POSSIBLE SPILL ON BOARD. THE COMPANY REPRESENTATIVE REPLACED THE FRONT END BROAD (PART NUMBER: 0670-00-0668E). THE IABP WAS TESTED TO FACTORY SPECIFICATION. IT FUNCTIONED NORMALLY AND WAS RETURNED TO THE CUSTOMER. SERVICE ON THE DEVICE WAS PERFORMED BY THE CUSTOMER. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AT THE START UP, THE CUSTOMER COULD NOT ZERO OUT THE IABP. THE PATIENT WAS SWITCHED TO ANOTHER IABP AND THERAPY COULD BE INITIATED. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250577 CS300 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP. CS300

    Patients

    Seq Age Sex Outcome Treatment
    1