BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID TYPE J PLUG

    MDR report key: 16243893 · Received January 25, 2023

    Report

    Report Number
    2249723-2023-00472
    Event Type
    Malfunction
    Date Received
    January 25, 2023
    Date of Event
    March 4, 2021
    Report Date
    January 25, 2023
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567111117
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE IABP UNIT AND INFORMED THAT THE STORAGE BINS WILL BE REPLACED DURING THE MAINTENANCE IN JUNE 2021. IN ADDITION, WE WERE INFORMED THAT THE CUSTOMER IS STILL USING THE DEVICE, BECAUSE THE DEFECTIVE BIN DIDN'T MAKE THE DEVICE UNUSABLE. THE FSE LATER INFORMED THAT THE STORAGE BINS (0441-00-0196) WERE REPLACED WHEN SCHEDULED PREVENTATIVE MAINTENANCE (PM) WAS PERFORMED. THE PM WAS COMPLETED WITH 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. THIS REPORT IS BEING SUBMITTED AS THE RESULT OF A RETROSPECTIVE REVIEW CONDUCTED IN CAPA: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAS A DEFECTIVE DRAWER GUIDE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1316089 CARDIOSAVE HYBRID TYPE J PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH 0998-00-0800-32 10607567111117

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown