BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS100

    MDR report key: 3980485 · Received June 5, 2014

    Report

    Report Number
    2249723-2014-00865
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    September 15, 2013
    Report Date
    September 15, 2013
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K031636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    BIOMEDICAL ENGINEER

    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 POWER UP. THE COMPANY REPRESENTATIVE REPLACED THE MAIN BOARD (PART NUMBER 0670-00-0788). THE IABP WAS TESTED TO FACTORY SPECIFICATION. IT FUNCTIONED NORMALLY AND WAS RETURNED TO THE CUSTOMER. THE MAIN BOARD REPLACED WAS RECEIVED BY THE MANUFACTURING FACILITY AT (B)(4). THE EVALUATION PERFORMED DID NOT CONFIRM THE FAILURE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A ROUTINE CHECK OF THE IABP, THE IABP FAILED TO POWER UP. NO PATIENT WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330313 CS100 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP. CS100

    Patients

    Seq Age Sex Outcome Treatment
    1