BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 16913887 · Received May 11, 2023

    Report

    Report Number
    2249723-2023-02322
    Event Type
    Malfunction
    Date Received
    May 11, 2023
    Date of Event
    May 2, 2023
    Report Date
    April 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
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, D9, G3, G6, H2, H3, H4, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES AND INVESTIGATION CONCLUSIONS), H10, H11. ADDITIONAL CUSTOMER CONTACT PHONE: (B)(6). A GETINGE FIELD SERVICE ENGINEER UPON INITIAL INSPECTION FOUND THE UNIT TO BE STUCK IN BOOT MODE. FSE WAS ABLE TO ACCESS THE SERVICE MODE AND FOUND FAULTS 101, 111, 102, 112, AND 118. PER SERVICE MANUALS THESE CODES CALL FOR REPLACEMENT OF EXECUTIVE PROCESSOR BOARD AND VIDEO GENERATOR BOARD. FSE STARTED BY REPLACING THE EXECUTIVE PROCESSOR BOARD( D670-00-0770) AND DOWNLOADED B.17. UNIT WORKED PROPERLY AFTER THIS BUT FOUND THE UNIT GAVE A "INTERNAL COMMUNICATION ERROR" WHILE TESTING FOR PM. FSE FOUND THE COIL CABLE TO BE THE CULPRIT, ALSO FOUND THE COIL CABLE NYLON CLIP TO BE BROKEN CAUSING THE COIL CABLE TO MOVE FREELY. FSE WILL BE ORDERING THE PARTS NEEDED AND RETURNING TO COMPLETE THE REPAIR.5/11/23 FSE RETURNED WITH PARTS NEEDED TO COMPLETE THE REPAIR. FSE REPLACED THE COIL CABLE(D012-00-1801), NYLON CLIP(D125-00-0028), BACKPLANE TO COIL CABLE CORD(D012-00-1796),AND CONNECTOR SEAL GASKET(D354-00-0201). FSE PERFORMED A FULL PM PER MANUFACTURE SPECIFICATIONS, PUMP DID NOT MALFUNCTION WHILE TESTING. UNIT HAS PASSED ALL TEST AND IS NOW READY FOR CLINICAL USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) DEVICE FAILED DURING TRANSPORT.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500896 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