BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE

    MDR report key: 3919571 · Received June 3, 2014

    Report

    Report Number
    2249723-2014-00587
    Event Type
    Malfunction
    Date Received
    June 3, 2014
    Date of Event
    June 14, 2013
    Report Date
    June 14, 2013
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE REPLACED THE EXECUTIVE PROCESSOR BOARD (PART NUMBER 0670-00-0770). THE IABP WAS TESTED TO FACTORY SPECIFICATION. IT FUNCTIONED NORMALLY AND WAS RETURNED TO THE CUSTOMER. THE REPLACED PART WAS SENT TO (B)(4) FACILITY FOR EVALUATION. THE RETURNED PART EVALUATION CONFIRMED THE FAILURE. THE FAILURE INVESTIGATION REPORT (FIR) WAS INITIATED AND ROOT CAUSE WAS IDENTIFIED AS THERMAL DAMAGE DUE TO SOLDERING PROCESS AND TWO POTENTIAL SOFTWARE ISSUES. SUBSEQUENTLY, TWO CAPAS WERE INITIATED FOR IMPLEMENTATION OF THE CHANGES IN THE PROCESS AS SUGGESTED BY FIR. (B)(4).

    Description of Event or Problem · 1

    DURING A ROUTINE CHECK/IN-SERVICE TRAINING OF THE IABP, THE COMPANY REPRESENTATIVE OBSERVED THAT IF THE IABP REMAINED OFF FOR MORE THAN THREE MINUTES, IT WOULD NOT AUTOMATICALLY RESTORE THE DEFAULT SETTINGS. ALL THE SETTINGS ARE RETAINED IN THE SYSTEM'S INTERNAL MEMORY. IN AUTO-MODE INTERMITTENTLY NOT POSSIBLE TO SET THE DEFLATION TIMING. NO PT WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323708 CARDIOSAVE INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP. CARDIOSAVE

    Patients

    Seq Age Sex Outcome Treatment
    1