BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID

    MDR report key: 3980494 · Received June 5, 2014

    Report

    Report Number
    2249723-2014-00877
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    December 4, 2013
    Report Date
    December 5, 2013
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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 WERE NO NON-CONFORMANCES IN THE DHR RELATED TO THE REPORTED EVENT. THE COMPANY SERVICE REPRESENTATIVE EVALUATED THE UNIT AND REPLACED THE CART POWER SUPPLY (PART NUMBER 0014-00-0255) AND UPGRADED THE SOFTWARE TO B.07. PERFORMED FULL CALIBRATION, FUNCTIONAL TESTING AND SAFETY CHECK TO MEET FACTORY SPECIFICATIONS. THE IABP WAS IN GOOD OPERATIONAL CONDITIONS AND WAS RELEASED TO THE CUSTOMER. THE POWER SUPPLY WAS RECEIVED BY THE MANUFACTURING FACILITY AT (B)(4). THE EVALUATION PERFORMED CONFIRMED THE FAILURE. THE POWER SUPPLY WAS SENT TO THE MANUFACTURED OR ADDITIONAL TESTING. A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A ROUTINE CHECK OF THE IABP, THE UNIT WOULD NOT POWER UP. NO PATIENT WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330388 CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP. CARDIOSAVE

    Patients

    Seq Age Sex Outcome Treatment
    1