BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300

    MDR report key: 3902633 · Received May 9, 2014

    Report

    Report Number
    2249723-2014-00566
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    September 17, 2012
    Report Date
    September 17, 2012
    Manufacturer
    DATASCOPE CORP
    Product Code
    DSP
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMP REP REPLACED THE FILTER TUBING ASSEMBLY (PART NUMBER: 0008-00-0331). THE IABP WAS TESTED TO FACTORY SPECIFICATION. IT FUNCTIONED NORMALLY AND WAS RETURNED TO THE CUSTOMER. THE MANUFACTURER TESTED THE RETURNED PART (P/N 0008-00-0331) ON A CS300 USING AN AUTOFILL CALIBRATION IN SVC DIAGNOSTICS AND DID NOT OBSERVE A MALFUNCTION. THE FUNCTIONAL TEST CONTINUED WITH AUTOMATIC AUTOFILLS EVERY TWO HOURS FOR A PERIOD OF 24 HOURS. THERE WERE NO AUTOFILL FAILURES DURING THE TEST PERIOD. REF: (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE THE IABP WAS IN USE ON A PT, THE IABP GENERATED AN "AUTO FILL FAILURE" ALARM AND WENT IN STANDBY FOR 17 MINS. THE IABP WAS REBOOTED AND WORKED FOR ONE MORE HOUR THAN THE IABP GENERATED THE SAME "AUTO FILL FAILURE" ALARM AND STOPPED. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282287 CS300 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP CS300

    Patients

    Seq Age Sex Outcome Treatment
    1