BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE

    MDR report key: 4030625 · Received July 29, 2014

    Report

    Report Number
    2249723-2014-01105
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Date of Event
    June 17, 2013
    Report Date
    June 17, 2013
    Manufacturer
    DATASCOPE CORP
    Product Code
    DSP
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP PROVIDED A LOANER IABP WHILE THE IABP WITH THE REPORTED EVENT COULD BE EVALUATED. THE COMPANY REP REPLACED THE POWER SUPPLY (PART NUMBER 0014-00-0255). THE COMPANY REP PERFORMED CALIBRATION, FUNCTIONAL, AND SAFETY TESTS. THE UNIT WAS FULLY OPERATIONAL AND WAS RETURNED TO THE CUSTOMER. THE POWER SUPPLY WAS RETURNED TO MAHWAH REPAIR CTR, NEW JERSEY FOR EVALUATION. AS PER THE FAILURE ANALYSIS REPORT (FIR) AND THE REVIEW OF THE ELECTRONIC DHR, THE POWER SUPPLY WERE ASSEMBLED PROPERLY AND THEREFORE, IMPROPER ASSEMBLY IS NOT THE CAUSE OF THE REPORTED EVENT. THE POWER SUPPLY WAS SENT O THE SUPPLY FOR ADDITIONAL TESTING AND EVALUATION. THE ROOT CAUSE WAS ATTRIBUTED TO ELECTRIC SHORT IN COMPONENT Q29 (TRANSISTOR). THE SUPPLIER SPECULATES THAT THE SHORT WAS DUE TO BY AN ARC IN THE CIRCUIT DUE TO POSSIBLE FLUS RESIDUE COUPLED WITH EXTERNAL CONTAMINATION OR HIGH HUMIDITY. THE SUPPLIER HAS INITIATED CORRECTIVE ACTION TO ADDRESS THIS ISSUE AND THE CHANGE IS IN PROCESS OF VALIDATION. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A ROUTINE CHECK OF THE IABP, THE BATTERIES WERE NOT CHARGING WHEN PLUGGED INTO THE AC OUTLET. NO PT WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442919 CARDIOSAVE INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP CARDIOSAVE

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR