BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 16296087 · Received February 3, 2023

    Report

    Report Number
    2249723-2023-00956
    Event Type
    Malfunction
    Date Received
    February 3, 2023
    Date of Event
    January 24, 2023
    Report Date
    March 7, 2024
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: E1(EVENT SITE TELEPHONE:(B)(6). EMAIL: (B)(6), SPOC: (B)(6), E3 IS UNKNOWN (INITIALLY IT IS SUBMITTED AS "OTHER HEALTHCARE PROFESSIONAL")) IT WAS REPORTED THAT CARDISAVE INTRA AORTIC BALLOON PUMP (IABP) HAD BROKEN HINGES. THERE WAS NO PATIENT INVOLVEMENT AND NO HARM REPORTED. A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED AND FOUND THAT THE HINGES ON THIS UNIT WERE BROKEN IN TWO DIFFERENT AREAS FOR THE STORAGE COMPARTMENTS. FSE REPLACED THE (D441-00-0196) STORAGE BIN CHASSIS ASSEMBLY AND COMPLETED A FULL SYSTEM TEST. ALL TESTS PASSED TO FACTORY SPECIFICATIONS. UNIT RETURNED TO THE CUSTOMER AND RELEASED FOR CLINICAL USE.

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT WILL BE UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORT THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP HINGES ON THE FRONT ACCESS PANEL HAVE BEEN BROKEN. NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2104929 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