BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP

    MDR report key: 3905510 · Received May 28, 2014

    Report

    Report Number
    2249723-2014-00768
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Date of Event
    November 13, 2013
    Report Date
    November 13, 2013
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD (DHR) FOR THE IABP INVOLVED IN THE EVENT WAS REVIEWED. THERE WAS NO NON-CONFORMANCES IN THE DHR RELATED TO THE REPORTED EVENT. THE IABP WAS RETURNED TO THE MANUFACTURING FACILITY AT (B)(4) AND THE UNIT IS UNDER EVALAUTION. A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    DURING AN INSTALLATION OF THE IABP, THE COMPANY REPRESENTATIVE OBSERVED THAT THE DISPLAY WAS NOT WORKING. NO PATIENT WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315041 CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP. CARDIOSAVE

    Patients

    Seq Age Sex Outcome Treatment
    1