BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300

    MDR report key: 4107211 · Received March 28, 2014

    Report

    Report Number
    2249723-2014-00204
    Event Type
    Malfunction
    Date Received
    March 28, 2014
    Date of Event
    January 20, 2014
    Report Date
    January 20, 2014
    Manufacturer
    DATASCOPE CORP
    Product Code
    DSP
    PMA / PMN Number
    K063525
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD (DHR) FOR THE IABP HAS BEEN REVIEWED. THERE ARE NO NON-CONFORMANCES NOTED IN THE DHR RELATED TO THE REPORTED EVENT. THE COMPANY REPRESENTATIVE TESTED THE PUMP WITH SIMULATOR AND ALSO TESTED CUSTOMER CABLES WITH A SIMULATOR. ALL LEADS SELECTED FUNCTIONED NORMALLY. PERFORMANCE TESTED TO FACTORY SPECS AND SAFETY TESTED. INTERNAL COMPLAINT NUMBER: (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE THE IABP WAS IN USE ON A PATIENT, THE IABP WOULD NOT DISPLAY ECG INFO ON THE PATIENT WITH THE PUMP. THE PATIENT WAS SWITCHED TO ANOTHER IABP AND THERAPY WAS CONTINUED. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185234 CS300 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP CS300 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other