BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID TYPE B PLUG

    MDR report key: 9467846 · Received December 13, 2019

    Report

    Report Number
    2249723-2019-02026
    Event Type
    Malfunction
    Date Received
    December 13, 2019
    Report Date
    December 12, 2019
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 COMPANY STANDARD OPERATING PROCEDURE SINCE THE DEVICE MANUFACTURE DATE IS GREATER THAN ONE YEAR FROM THE EVENT DATE. A GETINGE SERVICE TERRITORY MANAGER (STM) WAS DISPATCHED TO EVALUATE THE IABP. THE STM DETERMINED THAT THE REMOVABLE POWER SUPPLY WAS THE ISSUE, NOT THE PORTABLE CHARGER. TO ADDRESS THE ISSUE THE STM REPLACED THE POWER SUPPLY AND PERFORMED ALL FUNCTIONAL AND SAFETY TESTS WERE PASSED TO MEET FACTORY SPECIFICATIONS, AND THE IABP WAS RETURNED TO THE CUSTOMER AND CLEARED FOR CLINICAL SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PORTABLE CHARGER ON THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) WAS NOT FUNCTIONING. IT WAS LATER CLARIFIED THAT REMOVABLE POWER SUPPLY WAS NOT WORKING. IT IS UNKNOWN UNDER WHICH CIRCUMSTANCES THIS EVENT OCCURRED OR IF A PATIENT WAS INVOLVED; HOWEVER, THERE WAS NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1263830 CARDIOSAVE HYBRID TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1