BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSATION PLUS UNK.VOL

    MDR report key: 6697292 · Received July 10, 2017

    Report

    Report Number
    2248146-2017-00083
    Event Type
    Malfunction
    Date Received
    July 10, 2017
    Date of Event
    May 31, 2017
    Report Date
    July 10, 2017
    Manufacturer
    DATASCOPE FAIRFIELD
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH GOOD FAITH EFFORTS HAVE BEEN ATTEMPTED TO RETRIEVE THE DEVICE AS WELL AS ADDITIONAL INFORMATION, THE DEVICE WAS NOT RETURNED BY THE CUSTOMER AND SO COULD NOT BE EVALUATED. ALSO NO ADDITIONAL INFORMATION COULD BE RETRIEVED. WE ARE UNABLE TO CONFIRM THE REPORTED EVENT. IF NEW INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE DHR AND LHR REVIEW IS NOT ABLE TO BE PERFORMED SINCE THE PRODUCT INFO WAS NOT PROVIDED. THE COMPLAINT HISTORY REVIEW IS NOT ABLE TO BE PERFORMED SINCE THE LOT INFORMATION WAS NOT PROVIDED. WE ARE UNABLE TO CONFIRM THIS COMPLAINT. FIR / CAPA HISTORY EVALUATION: EVALUATION OF DEVICE COULD NOT BE PERFORMED SINCE IT WAS NOT RETURNED. NO ROOT CAUSE COULD BE IDENTIFIED FOR FIR/CAPA HISTORY EVALUATION. (B)(4).

    Description of Event or Problem · 1

    A PATIENT UNDERWENT INTRA-AORTIC BALLOON (IAB) CATHETER THERAPY IN THE O.R. THE USER WAS UNABLE TO GET PRESSURE READINGS. THE IAB WAS REMOVED AND REPLACED WITH A 2ND IAB SUCCESSFULLY. THERE WAS NO INJURY OR HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478641 SENSATION PLUS UNK.VOL SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE FAIRFIELD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1