BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM98XT

    MDR report key: 4030776 · Received July 29, 2014

    Report

    Report Number
    2249723-2014-01071
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Date of Event
    October 18, 2011
    Report Date
    October 18, 2011
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K961509
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP REPLACED THE SAFETY DISK ASSEMBLY (PART NUMBER 0997-00-0985-01) AND THE CONDENSATE REMOVAL MODULE (CRM) (PART NUMBER 0997-00-0986-01). THE COMPANY REP ALSO REPLACED AUTOFILL LUER FITTING (PART NUMBER 0103-00-0398-01). THE FITTING (PART NUMBER 0103-00-0398-01). THE COMPANY REP PERFORMED PREVENTIVE MAINTENANCE, CALIBRATION, FUNCTIONAL TESTS AND SAFETY CHECKS. THE UNIT MET FACTORY SPECS AND WAS RETURNED TO THE CUSTOMER. (B)(4).

    Description of Event or Problem · 1

    DURING PREVENTIVE MAINTENANCE, THE COMPANY REP OBSERVED THAT THE UNIT FAILED TO THE SAFETY DISK LEAK TEST. NO PT WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442909 SYSTEM98XT INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP. SYSTEM98XT

    Patients

    Seq Age Sex Outcome Treatment
    1