BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID W/ E/F PLUG

    MDR report key: 16264344 · Received January 30, 2023

    Report

    Report Number
    2249723-2023-00694
    Event Type
    Malfunction
    Date Received
    January 30, 2023
    Date of Event
    February 10, 2022
    Report Date
    January 18, 2023
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567108414
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE IABP. THE FSE REPLACED THE COMPLETE TROLLEY (0997-00-1179) AND PUT THE VARIOUS ELEMENTS BACK IN PLACE. THE TROLLEY TESTED OKAY. THE FSE ALSO REPLACED THE UPPER HINGE COVER (0380-00-0561. THE IABP WAS TESTED AND FOUND TO BE FUNCTIONING PROPERLY. 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 FOLLOWING A TRANSPORT ACCIDENT, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD A BROKEN WHEEL ON THE LOWER PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2944 CARDIOSAVE HYBRID W/ E/F PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH 0998-00-0800-55 10607567108414

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown