BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 98XT

    MDR report key: 3950680 · Received June 6, 2014

    Report

    Report Number
    2249723-2014-00861
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    October 16, 2013
    Report Date
    November 5, 2013
    Manufacturer
    DATASCOPE CORP
    Product Code
    DSP
    PMA / PMN Number
    K961509
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD (DHR) FOR THE IABP INVOLVED IN THE EVENT WAS REVIEWED. THERE WERE NO NON-CONFORMANCES IN THE DHR RELATED TO THE REPORTED EVENT. THE COMP REP WAS UNABLE TO DUPLICATE THE REPORTED EVENT. THE IABP WAS TESTED TO FACTORY SPECIFICATIONS. IT FUNCTIONED NORMALLY AND WAS RETURNED TO THE CUSTOMER. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE THE IABP WAS IN USE ON A PT, APPROXIMATELY A HALF AN HOUR AFTER TRANSFERRING THE PT FROM THE CATH LAB TO CCU, THE IABP GENERATED NUMEROUS "LEAK IN IAB CIRCUIT" ALARMS. THE CUSTOMER WAS NOT ABLE TO CLEAR THE ALARMS. THE PT WAS SWITCHED TO ANOTHER IABP AND THERAPY WAS CONTINUED. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331604 SYSTEM 98XT INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP SYSTEM 98XT

    Patients

    Seq Age Sex Outcome Treatment
    1