BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID W/ E/F PLUG

    MDR report key: 16426223 · Received February 23, 2023

    Report

    Report Number
    2249723-2023-01227
    Event Type
    Malfunction
    Date Received
    February 23, 2023
    Date of Event
    February 8, 2023
    Report Date
    January 8, 2024
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567108414
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE IABP UNIT AND THE FUNCTIONAL TESTS COMPLETED WHICH CONCLUDES "NO DIRECT RISK; ANY DEFECTS IDENTIFIED CAN BE REMEDIED AT SHORT NOTICE" - TENSION ROLLER FOR POWER CABLE AND DAMAGE TO FIBER OPTIC BUT STILL WITHIN TOLERANCE. THE FSE HAS NOTED THAT THE DEVICE HAS PASSED AND IS IN USE AGAIN. REPAIRS TO THE SENSOR AND TENSION ROLLER WERE RECOMMENDED. UNIT HAS BEEN RELEASED BACK TO CUSTOMER WITH PENDING REPAIRS RECOMMENDED THAT DO NOT AFFECT FUNCTIONALITY.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE ON A PATIENT, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT CANNOT DISPLAY AN ARTERIAL PRESSURE WAVEFORM FROM THE FIBEROPTIC BALLOON. ERROR MESSAGE READ: IAB SENSOR ERROR OR IAB SENSOR MODULE ERROR (CUSTOMER WAS NOT SURE HERE). AFTER THE PUMP WAS EXCHANGED FOR ANOTHER CARDIOSAVE, THE PRESSURE CURVE COULD BE DISPLAYED ON THE NEW IABP WITHOUT ANY PROBLEMS. THERE WAS NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448492 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