BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID TYPE B PLUG

    MDR report key: 8922741 · Received August 22, 2019

    Report

    Report Number
    2249723-2019-01334
    Event Type
    Malfunction
    Date Received
    August 22, 2019
    Date of Event
    July 30, 2019
    Report Date
    September 11, 2019
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING TRANSPORT OF A PATIENT, THE AC TRANSPORT POWER SUPPLY FOR THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) WAS NOT FUNCTIONING. THERE WAS NO ADVERSE EVENT REPORTED.

    Additional Manufacturer Narrative · 1

    THE PRODUCTION DEVICE HISTORY RECORD (DHR) FOR THIS INTRA-AORTIC BALLOON PUMP (IABP) WAS NOT REQUIRED TO BE REVIEWED AS 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 INVESTIGATE AND REPLACED THE REMOVABLE POWER SUPPLY TO RESOLVE THE ISSUE. SUBSEQUENTLY, THE STM COMPLETED ALL SAFETY, FUNCTIONALITY, AND CALIBRATION CHECKS AND ALL TESTS PASSED TO FACTORY SPECIFICATIONS. THE IABP UNIT WAS CLEARED FOR CLINICAL USE AND RELEASED TO THE CUSTOMER. (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE AC TRANSPORT POWER SUPPLY FOR THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) WAS NOT FUNCTIONING. 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
    716344 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