BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 16253397 · Received January 27, 2023

    Report

    Report Number
    2249723-2023-00544
    Event Type
    Malfunction
    Date Received
    January 27, 2023
    Date of Event
    October 27, 2021
    Report Date
    March 6, 2024
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS THE RESULT OF A RETROSPECTIVE REVIEW CONDUCTED IN CAPA (B)(4). A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE IABP. THE FSE STATED THAT SCREWS WERE FOUND MISSING FROM THE DISPLAY MOUNT AND THE MOUNT HAD MULTIPLE DAMAGED THREADS. THE FSE REPLACED THE DISPLAY MOUNT (0426-00-0098) AND ASSOCIATED SCREWS (0212-12-0605). THE FSE PERFORMED CALIBRATION, SAFETY, AND FUNCTIONALITY CHECKS WHICH PASSED TO FACTORY SPECIFICATIONS. THE IABP WAS THEN RETURNED TO THE CUSTOMER AND CLEARED FOR CLINICAL SERVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD A SCREW THAT BROKE OFF FROM THE SCREEN MOUNT. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409124 CARDIOSAVE HYBRID, TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH 0998-00-0800-53 10607567108391

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown