BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CS300

    MDR report key: 3872057 · Received April 17, 2014

    Report

    Report Number
    2249723-2014-00467
    Event Type
    Injury
    Date Received
    April 17, 2014
    Date of Event
    October 16, 2013
    Report Date
    October 16, 2013
    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 COMPANY REPRESENTATIVE OBSERVED "LOW VACUUM" ALARM IN THE FAULT LOG, WHICH CAN OCCUR DUE TO A LOOSE SAFETY DISK. THE CUSTOMER HAD TURNED THE SAFETY DISK A 1/4 TURN CLOCKWISE AND SECURED THE PART PRIOR TO THE SERVICE VISIT FROM THE COMPANY REPRESENTATIVE. THE COMPANY REPRESENTATIVE WAS UNABLE TO DUPLICATE THE REPORTED PROBLEM. THE IABP WAS TESTED TO FACTORY SPECIFICATION. IT FUNCTIONED NORMALLY AND WAS RETURNED TO THE CUSTOMER. INTERNAL FILE: (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE THE IABP WAS IN USE ON A PATIENT, THE IABP GENERATED AN "AUTOFILL FAILURE" ALARM. THE CUSTOMER REPORTED THAT THE SAFETY DISK WAS LOOSE WHEN THE EVENT OCCURRED. THE PATIENT WAS SWITCHED TO ANOTHER IABP AND THERAPY CONTINUED. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234895 CS300 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP. CS300

    Patients

    Seq Age Sex Outcome Treatment
    1 Other