BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300 INTRA-AORTIC PUMP

    MDR report key: 3894493 · Received April 25, 2014

    Report

    Report Number
    2249723-2014-00494
    Event Type
    Malfunction
    Date Received
    April 25, 2014
    Date of Event
    October 11, 2014
    Report Date
    October 11, 2014
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE DEVICE HISTORY RECORD (DHR) FOR THE IABP INVOLVED IN THE EVENT WAS REVIEWED. THERE WERE NO NON-CONFORMANCE IN THE DHR RELATED TO THE REPORTED EVENT. THE COMPANY REPRESENTATIVE PROCEEDED AS PRECAUTIONARY STEP PROCEEDED TO REPLACE THE FIBER OPTIC MODULE" (PART #0997-00-1161E). THE PM WAS COMPLETED, PERFORMED THE FUNCTIONAL TESTS AND SAFETY CHECKS TO FACTORY SPECIFICATIONS THE PUMP WAS RETURNED TO THE CUSTOMER. THE PARTS REPLACED WERE RECEIVED BY THE MANUFACTURING FACILITY AT (B)(4) FOR EVALUATION. THE TEST TO THE DRIVE ASSEMBLY SHOWED THAT THERE WAS NO FAILURE. THE J5 CONNECTOR ON PART #0670-00-0771 BOARD WAS INTACT. SIMILARLY, THE EVALUATION PERFORMED TO THE FIBER OPTIC MODULE RESULTED THAT WAS IN GOOD OPERATIONAL CONDITIONS AND IT WAS RETURNED INTO STOCK. (B)(4).

    Description of Event or Problem · 1

    THE COMPANY REPRESENTATIVE REPORTED THAT DURING A PREVENTATIVE MAINTENANCE, THE FIBER OPTIC MODULE CONNECTION TO BEDSIDE MONITOR WAS BROKEN, WOULD NOT LOCK IN CABLE. MODULE WORKED OTU BUT COULD BE INTERMITTENT. IT WAS ALSO FOUND THAT UNIT FAILED THE K6, K6A, K7 AND K8 LEAK TEST. NO PATIENT WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252639 CS300 INTRA-AORTIC PUMP INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP. CS300

    Patients

    Seq Age Sex Outcome Treatment
    1