BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 16097673 · Received January 4, 2023

    Report

    Report Number
    2249723-2023-00071
    Event Type
    Malfunction
    Date Received
    January 4, 2023
    Date of Event
    December 19, 2022
    Report Date
    April 2, 2024
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4,D9,E1(SITE COUNTRY),E2,G3,G6,H2,H3,H4,H6(TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES, INVESTIGATION CONCLUSIONS), H10. IT WAS REPORTED THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD A ISSUE OF MONITOR TO UNIT COMMUNICATION ISSUE. THERE WAS NO PATIENT INVOLVEMENT, AND NO ADVERSE EVENT WAS REPORTED. A GETINGE FIELD SERVICE ENGINEER AFTER INSPECTING UNIT FSE REPLACED THE COILED CABLE CORD (D012-00-180) & SEAL GASKET(D354-00-0201). FSE ALSO REPLACED THE BACKPLANE TO COILED CORD CABLE(D012-00-1796). FSE ALSO REPLACED THE EXECUTIVE PROCESSOR BOARD(D670-00-0770) . FSE PERFORMED A PM, A FULL CALIBRATION, AND TESTED THE UNIT. THE EQUIPMENT WORKS TO THE MANUFACTURER¿S SPECS, IS CLEARED FOR CLINICAL USE, AND WAS RETURNED TO THE CUSTOMER. BACKPLANE BOARD WAS USED FOR TROUBLESHOOTING PURPOSES ONLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNITS MONITOR HAS A COMMUNICATION ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1117817 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 N/A.