BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 98XT

    MDR report key: 3950694 · Received June 6, 2014

    Report

    Report Number
    2249723-2014-00864
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    November 25, 2013
    Report Date
    November 25, 2013
    Manufacturer
    DATASCOPE CORP.,
    Product Code
    DSP
    PMA / PMN Number
    K961509
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMP REP OBSERVED THAT THE IABP FAILED THE K6/K7/K8 LEAK TEST. THE MANIFOLD DRIVE AND K6A SOLENOID FAILED. THE COMP REP REPLACED THE MANIFOLD DRIVE (PART NO: 0104-00-0018) AND THE K6A VENT VALVE (0119-00-0170). THE IABP WAS TESTED TO FACTORY SPECIFICATIONS. IT FUNCTIONED NORMALLY AND WAS RETURNED TO THE CUSTOMER. THE DRIVE MANIFOLD REPLACED WAS RECEIVED BY THE MANUFACTURING FACILITY AT (B)(4) AND IS ON EVAL. A SUPPLEMENTAL MDR WILL BE SUBMITTED WHEN ADD'L INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A PREVENTIVE MAINTENANCE ON THE IABP, THEY OBSERVED THAT THE IABP FAILED THE K6/K7/K8 LEAK TEST. NO PT WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332295 SYSTEM 98XT INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP., SYSTEM 98XT

    Patients

    Seq Age Sex Outcome Treatment
    1