BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE

    MDR report key: 2862133 · Received November 29, 2012

    Report

    Report Number
    2249723-2012-00375
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    September 16, 2012
    Report Date
    September 17, 2012
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS NOTED ABOVE, THE IABP STOPPED PUMPING AND WENT INTO STANDBY MODE. IT WAS THEN REBOOTED AND PROVIDED THERAPY. THE PUMP WAS THEN SWITCHED OUT OF PRECAUTION. DATASCOPE WAS NOT ABLE TO REPRODUCE THE REPORTED ISSUE. THE CUSTOMER HAS BEEN PROVIDED WITH SOFTWARE WHICH IS UPGRADED/MORE ROBUST, AS AN ACCOMMODATION. THE ISSUE HAS NOT RECURRED SINCE THE EVENT DATE OF (B)(6) 2012. DATASCOPE WILL CONTINUE TO MONITOR FIELD DATA FOR ANY INDICATION OF A TREND.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE THE IABP WAS IN USE ON A PT, THE IABP STOPPED PUMPING AND WENT INTO STANDBY MODE DURING TREATMENT WITHOUT AN ALARM. THE IABP WAS IN AUTO MODE AT THE TIME OF THE EVENT. THERE WERE NOT ABLE TO REFILL THE BALLOON OR CONTINUE TO ASSIST THE PT. THE IABP WAS REBOOTED, 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
    1 CARDIOSAVE INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP. CARDIOSAVE

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK