BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS100 INTRA-AORTIC PUMP

    MDR report key: 4107329 · Received March 28, 2014

    Report

    Report Number
    2249723-2014-00206
    Event Type
    Malfunction
    Date Received
    March 28, 2014
    Date of Event
    February 4, 2014
    Report Date
    February 4, 2014
    Manufacturer
    DATASCOPE CORP
    Product Code
    DSP
    PMA / PMN Number
    K031636
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE DEVICE HISTORY RECORD (DHR) FOR THE IABP INVOLVED IN THE EVENT WAS REVIEWED. THERE WERE NO NON-CONFORMANCES IN THE DHR RELATED TO THE REPORTED EVENT. THE COMPANY REP WAS ABLE TO DUPLICATE THE EVENT. IT WAS CONFIRMED THAT THE FIBER OPTIC MODULE WAS NOT WORKING. A NEW REPLACEMENT MODULE WAS INSTALLED. ALL FUNCTIONAL AND SAFETY TESTS WERE COMPLETED AND THE IABP WAS RETURNED BACK TO THE CUSTOMER. THE FIBER OPTIC MODULE HAS BEEN REQUESTED TO BE RETURNED TO THE MFG FACILITY IN (B)(6) FOR EVAL. A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED IF THE PART IS RECEIVED AND THE EVAL IS COMPLETED. REF: (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER (GE BIOMED REO) REQUESTED FOR SERVICE ON CS100 INDICATING "ERROR UPON BOOT UP OPTICAL MODULE SENSING FAILURE". THIS HAPPENED PRIOR TO USE ON A PT. THE PUMP WAS REPLACED AND THERAPY WAS CONTINUED. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185591 CS100 INTRA-AORTIC PUMP INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP CS100

    Patients

    Seq Age Sex Outcome Treatment
    1 Other