BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID INTRA-AORTIC PUMP

    MDR report key: 4107098 · Received March 28, 2014

    Report

    Report Number
    2249723-2014-00007
    Event Type
    Malfunction
    Date Received
    March 28, 2014
    Date of Event
    January 13, 2014
    Report Date
    January 13, 2014
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    NOT APPLICABLE

    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 FRONT END BOARD (PART NUMBER 0670-00-0769) WAS REPLACED. IT IS BEING RETURNED TO THE FACTORY FOR FURTHER ANALYSIS. THE FRONT END BOARD WAS RECEIVED AT THE MANUFACTURING FACILITY IN (B)(4) FOR EVALUATION. A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A COMPANY SERVICE REPRESENTATIVE REPORTED THAT WHILE THE IABP WAS IN THE SERVICE WORKSHOP, IT FAILED TO POWER UP. THE IABP WAS NOT IN THE CART. A SYMBOL ON THE LOWER SCREEN WAS TURNING CLOCKWISE AND THE "MAQUET" SYMBOL ON THE UPPER SCREEN WAS LIGHTED. HE RESTARTED THE IABP AFTER 3 TO 4 MINUTES AND RECEIVED THE SAME RESULT. HE ATTEMPTED TO RESTART THE IABP A TOTAL OF 3 TIMES. ON THE LAST RESTART, THE IABP POWERED UP CORRECTLY. NO PATIENT WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185345 CARDIOSAVE HYBRID INTRA-AORTIC PUMP INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP. CARDIOSAVE

    Patients

    Seq Age Sex Outcome Treatment
    1