BEUDAMED
    FDA Adverse Event Death Summary report: N

    SENSATION 7FR. 40CC IAB

    MDR report key: 3931244 · Received June 26, 2014

    Report

    Report Number
    2248146-2014-00120
    Event Type
    Death
    Date Received
    June 26, 2014
    Date of Event
    March 28, 2011
    Report Date
    April 18, 2011
    Manufacturer
    DATASCOPE CORP.,
    Product Code
    DSP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED WITH THE MEMBRANE COMPLETELY UNFOLDED. ONE KINK WAS OBSERVED 76.2CM FROM THE TIP. PRODUCT EVALUATION - A SENSOR OUTPUT TEST WAS PERFORMED AND A PRESSURE READING COULD NOT BE OBTAINED. THE TECH USED AN OPTICAL LIGHT TO SEE IF THERE WERE ANY BREAKS IN THE SENSOR'S OPTICAL FIBER. CONCLUSION: THE SENSOR WAS FOUND TO BE DAMAGED AT THE TIP. ALTHOUGH WE CANNOT DETERMINE HOW THIS OCCURRED, A DAMAGED SENSOR WILL CAUSE THE REPORTED ALARMS. (B)(4).

    Description of Event or Problem · 1

    BALLOON WAS INSERTED AND WHEN IT WAS CONNECTED TO THE CONSOLE, THE CONSOLE DID NOT RECOGNIZE THE FIBER OPTIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374183 SENSATION 7FR. 40CC IAB INTRA-AORTIC BALLOON DSP DATASCOPE CORP., 0684-00-0434 2486

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death