BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 16243643 · Received January 25, 2023

    Report

    Report Number
    2249723-2023-00437
    Event Type
    Malfunction
    Date Received
    January 25, 2023
    Date of Event
    October 28, 2020
    Report Date
    January 25, 2023
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE IABP UNIT AND WAS ABLE TO REPRODUCE THE REPORTED ISSUE. TO FIX THE ISSUE, THE FSE REPLACED THE SLIDE HANDLE ASSEMBLY (0997-00-0587) AND WHEELS ASSEMBLY (0997-00-0588) PER THE CUSTOMER'S REQUEST. PM WAS PERFORMED DURING THE SAME SERVICE VISIT. FULL CALIBRATION, FUNCTIONAL, AND SAFETY CHECKS WERE PERFORMED WHICH PASSED TO MEET FACTORY SPECIFICATIONS. THE IABP WAS THEN RELEASED TO THE CUSTOMER AND CLEARED FOR CLINICAL SERVICE. 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 DURING PREVENTIVE MAINTENANCE (PM) PERFORMED BY A GETINGE FIELD SERVICE ENGINEER (FSE), THE RETRACTABLE HANDLE OF THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) WAS STICKING. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1316077 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 Unknown