BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS100

    MDR report key: 3905525 · Received May 28, 2014

    Report

    Report Number
    2249723-2014-00779
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Date of Event
    November 22, 2013
    Report Date
    November 22, 2013
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K031636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 REPRESENTATIVE OBSERVED THAT THE IABP FAILED TO BOOT UP. THE COMPANY REPRESENTATIVE REPLACED THE MAIN BOARD (PART NUMBER 0670-00-0788). THE IABP WAS TESTED TO FACTORY SPECIFICATIONS. IT FUNCTIONED NORMALLY AND THE UNIT WAS RELEASED FOR USE. THE MAIN BOARD REPLACED WAS RECEIVED BY THE MANUFACTURING FACILITY AT (B)(4). THE FAILURE ANALYSIS PERFORMED SHOWED THAT EVENT COULD NOT BE DUPLICATED. AFTER EXTENSIVE TESTING, THE BOARD WAS FOUND IN GOOD WORKING CONDITION AND IT WAS RETURNED TO STOCK. (B)(4).

    Description of Event or Problem · 1

    DURING A ROUTINE CHECK AFTER UNPACKING THE IABP BY THE COMPANY SERVICE REPRESENTATIVE AT THE (B)(6) MAQUET OFFICE, IT WAS OBSERVED THAT WHEN THE IABP WAS POWERED UP, THE KEYBOARD FLASHED ONCE BUT THERE WAS NOTHING ON DISPLAY OR ANY OTHER RESPONSE. THE IABP FAILED TO BOOT UP. NO PATIENT WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315044 CS100 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP. CS100

    Patients

    Seq Age Sex Outcome Treatment
    1