BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300

    MDR report key: 3963692 · Received May 2, 2014

    Report

    Report Number
    2249723-2014-01163
    Event Type
    Malfunction
    Date Received
    May 2, 2014
    Date of Event
    December 10, 2012
    Report Date
    December 11, 2012
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SERVICE REPRESENTATIVE REPLACED THE IABP VOLUME CYLINDER (PART NUMBER 020-00-0133). THE IABP WAS FUNCTIONALLY TESTED AND RETURNED TO THE CUSTOMER. (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 IS NOT SURE IF THE PATIENT WAS SWITCHED TO ANOTHER IABP. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265628 CS300 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP. CS300

    Patients

    Seq Age Sex Outcome Treatment
    1