BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSATION PLUS 7.5FR. 40CC IAB & ACCESSORIES

    MDR report key: 19386743 · Received May 23, 2024

    Report

    Report Number
    2248146-2024-00335
    Event Type
    Malfunction
    Date Received
    May 23, 2024
    Date of Event
    May 10, 2024
    Report Date
    November 19, 2024
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108063
    PMA / PMN Number
    K122628
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INITIAL REPORTER(S): (B)(6). THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER SO WE ARE UNABLE TO COMPLETE AN EVALUATION. IF PROVIDED WE WILL SEND A SUPPLEMENTAL REPORT WITH OUR ADDITIONAL FINDINGS. COMPLAINT RECORD ID # 1040484 H3 OTHER TEXT : DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 0

    PROVIDING UPDATED DEVICE IDENTIFICATION INFORMATION IN ALIGNMENT WITH GUDID. COMPLAINT RECORD ID # (B)(4).

    Additional Manufacturer Narrative · 0

    A PUMP PRESSURE CABLE WAS RETURNED. THE IAB CATHETER WAS NOT RETURNED. WE ARE UNABLE TO CONFIRM THE REPORTED EVENT. IF THE DEVICE BECOMES AVAILABLE FOR RETURN, A NEW EVALUATION LETTER WILL BE PROVIDED. REFERENCE COMPLAINT: (B)(4). H3 OTHER TEXT : INCORRECT DEVICE RETURNED. THE RETURNED DEVICE IS AN INTRA-AORTIC BALLOON PUMP (IABP) CABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING INTRA-AORTIC BALLOON (IAB) THERAPY, A FIBER OPTIC SENSOR FAILURE ALARM OCCURRED. THE CUSTOMER WAS ADVISED TO REMOVE AND REINSERT THE FIBEROPTIC SENSOR, BUT THIS DID NOT RESOLVE THE ALARM. THEY WERE THEN INSTRUCTED TO REMOVE THE FIBEROPTIC SENSOR, COIL IT UP AND MARK IT BROKEN. THEY TRANSDUCED THE INNER LUMEN FOR THE ARTERIAL WAVEFORM; IT WAS ALREADY ZEROED AND THERAPY RESUMED. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9831 SENSATION PLUS 7.5FR. 40CC IAB & ACCESSORIES SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0684-00-0568-01 3000365109 10607567108063

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female