BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE

    MDR report key: 7638597 · Received June 26, 2018

    Report

    Report Number
    2249723-2018-01082
    Event Type
    Malfunction
    Date Received
    June 26, 2018
    Date of Event
    June 5, 2018
    Report Date
    June 26, 2018
    Manufacturer
    DATASCOPE MAHWAH
    Product Code
    DSP
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCTION DEVICE HISTORY RECORD (DHR) FOR THIS INTRA-AORTIC BALLOON PUMP (IABP) WAS NOT REQUIRED TO BE REVIEWED PER THE COMPANY STANDARD OPERATING PROCEDURE SINCE THE DEVICE MANUFACTURE DATE IS GREATER THAN ONE YEAR FROM THE EVENT DATE. A GETINGE SERVICE TERRITORY MANAGER (STM) EVALUATED THE IABP AND VERIFIED THAT THE REMOVABLE POWER SUPPLY WAS NOT WORKING. THE STM REPLACED THE POWER SUPPLY AND TESTED IT ON THE IABP. THE POWER SUPPLY AND THE IABP PASSED ALL TESTING AND WERE RELEASED BACK TO THE CUSTOMER FOR CLINICAL USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PREVENTIVE MAINTENANCE (PM) PERFORMED BY THE CUSTOMER, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) POWER SUPPLY WAS NOT FUNCTIONING. NO PATIENT WAS INVOLVED AND NO ADVERSE EVENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478931 CARDIOSAVE SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE MAHWAH N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1