BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSATION PLUS 8FR. 50CC IAB WITH ACCESSORIES, US ONLY

    MDR report key: 12473764 · Received September 15, 2021

    Report

    Report Number
    12473764
    Event Type
    Malfunction
    Date Received
    September 15, 2021
    Date of Event
    July 23, 2021
    Report Date
    September 10, 2021
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING SURGICAL PROCEDURE FOR CORONARY BYPASS, DEVICE WAS PLACED INTO PATIENT'S AORTA VIA FEMORAL ARTERY. THE FIBER OPTIC CABLE AT END OF DEVICE SHOULD READ PATIENT'S BLOOD PRESSURE. THE DEVICE DID NOT START AND SYNC. ERROR MESSAGE FROM MACHINE "IAB OPTICAL SENSOR FAILURE. REP WAS CALLED TO TROUBLE SHOOT. DEVICE STAYED IN FOR THE MAJORITY OF THE SURGICAL PROCEDURE. PATIENT'S ARTERIAL PRESSURE AND EKG WERE USED FOR THE TRIGGER AND READING. DEVICE WAS EXCHANGED WITH A NEW BALLOON AFTER CROSS CLAMP REMOVED BUT NOT OFF BYPASS. THE PATIENT'S STATUS DID NOT CHANGE FROM ORIGINAL DEVICE AND EXCHANGED WITH NEW DEVICE. THE DEVICE WAS SEQUESTERED AND RETURNED TO VENDOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1372185 SENSATION PLUS 8FR. 50CC IAB WITH ACCESSORIES, US ONLY SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0684-00-0576-01U 3000148556-01U

    Patients

    Seq Age Sex Outcome Treatment
    1 18980 DA Other