BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300

    MDR report key: 3874778 · Received April 25, 2014

    Report

    Report Number
    2249723-2014-00523
    Event Type
    Malfunction
    Date Received
    April 25, 2014
    Date of Event
    October 12, 2013
    Report Date
    October 18, 2013
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED INCIDENT OF "ALARM DETECTED" ALARM WAS NOT DUPLICATED. AS A PREVENTATIVE MEASURE, THE BLOOD DETECT SENSOR OF THE IABP WAS CALIBRATED BY FSE ON (B)(4) 2013. AFTER CALIBRATION, THE IABP FUNCTIONED NORMALLY AND RETURNED TO CLINICAL USE. NOTE: THE IABP IS MAQUET OWNED DEVICE USED FOR RENTAL AND/OR DEMONSTRATION. (B)(4) .

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE THE IABP WAS IN USE ON A PT, THE IABP GENERATED A "BLOOD DETECTED" ALARM TWICE. THE CUSTOMER OBSERVED NO EVIDENCE OF RUPTURE OF THE IABP. THE CUSTOMER REBOOTED THE IABP AND THERAPY WAS CONTINUED ON THE SAME IABP AFTER BOTH TIMES THE "BLOOD DETECTED" ALARM WAS GENERATED. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250578 CS300 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP. CS300

    Patients

    Seq Age Sex Outcome Treatment
    1