BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM98XT

    MDR report key: 4030619 · Received July 29, 2014

    Report

    Report Number
    2249723-2014-01027
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Date of Event
    September 17, 2011
    Report Date
    September 19, 2011
    Manufacturer
    DATASCOPE CORP
    Product Code
    DSP
    PMA / PMN Number
    K961509
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP CONFIRMED THE REPORTED EVENT OF THE FIBER OPTIC PRESSURE WAS NOT WORKING. THE FIBER OPTIC MODULE (PART NUMBER 0997-00-1161E) WAS REPLACED. THE IABP UNIT WAS CALIBRATED AND THE FACTORY SPECIFICATIONS WERE MET. THE UNIT WAS RETURNED TO THE CUSTOMER. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT PRIOR TO USE ON A PT THE UNIT WOULD NOT DISPLAY THE WAVEFORM FRO THE FIBER OPTIC BALLOON. THE PUMP WAS REPLACED AND THERAPY WAS INITIATED. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442918 SYSTEM98XT UBTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP SYSTEM98XT

    Patients

    Seq Age Sex Outcome Treatment
    1