BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300

    MDR report key: 3902632 · Received May 9, 2014

    Report

    Report Number
    2249723-2014-00554
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    August 26, 2013
    Report Date
    August 26, 2013
    Manufacturer
    DATASCOPE CORP
    Product Code
    DSP
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ON THE EVENT DATE, (B)(6) 2013, THE FSE PROVIDED THE RENTAL IABP UNIT AND EVALUATED THE ORIGINAL IABP UNIT. THE "AUTOFILL FAILURE" ALARM WAS CONFIRMED ON THE FAULT LOG. BUT, THE "MAINTENANCE REQUIRED CODE #2" (DRIVE TRANSDUCER OFFSET FAILURE) WAS NOT CONFIRMED ON THE FAULT LOG. THE IABP UNIT PASSED ALL PNEUMATIC CALIBRATIONS. SCHEDULED PREVENTIVE MAINTENANCE WAS PERFORMED ON (B)(4) 2013 AND THE IABP UNIT MET FACTORY SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE THE IABP WAS IN USE ON A PT, THE IABP GENERATED "AUTO FILL FAILURE" AND "MAINTENANCE REQUIRED CODE #2" (DRIVE TRANSDUCER OFFSET FAILURE) 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
    282312 CS300 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP CS300

    Patients

    Seq Age Sex Outcome Treatment
    1