BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300

    MDR report key: 4093223 · Received August 21, 2014

    Report

    Report Number
    2249723-2014-01214
    Event Type
    Malfunction
    Date Received
    August 21, 2014
    Date of Event
    April 27, 2012
    Report Date
    April 27, 2012
    Manufacturer
    DATASCOPE COR.
    Product Code
    DSP
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN FOUND ELECTRONIC ERROR CODE 51, MOISTURE DAMAGE ON THE MOTOR CONTROLLER BOARD (PART NUMBER: 0671-00-0004) AND BROKEN IV POLE RETAINING ASSEMBLY (PART NUMBER 0105-00-0114). BOTH PARTS WERE REPLACED. THE TECHNICIAN PERFORMED CALIBRATION, FUNCTIONAL TESTS AND SAFETY CHECKS. THE IABP MET FACTORY SPECIFICATIONS AND WAS RETURNED TO THE CUSTOMER. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THERE WAS A FLUID SPILL ON THE UNIT. THE PUMP WAS REPLACED. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504547 CS300 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE COR. CS300

    Patients

    Seq Age Sex Outcome Treatment
    1