BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300

    MDR report key: 2072836 · Received March 31, 2011

    Report

    Report Number
    2249723-2011-00041
    Event Type
    Malfunction
    Date Received
    March 31, 2011
    Date of Event
    March 6, 2011
    Report Date
    March 7, 2011
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE COULD NOT REPRODUCE THE REPORTED PROBLEM. HOWEVER, HE FOUND THE REPORTED ALARMS IN THE ERROR LOG. IN ADDITION HE OBSERVED THE FAULT 45 (SYSTEM FAILURE) AND THE FAULT 61 (EXCESS DRIVE PRESSURE TRANSDUCER) IN THE FAULT JOURNAL. THE COMPANY REPRESENTATIVE REPLACED THE FRONT END BOARD ((B)(4)) AND THE DRIVE TRANSDUCER ((B)(4)). THE UNIT WAS TESTED TO FACTORY SPECIFICATION. IT FUNCTIONED NORMALLY AND WAS RETURNED TO THE CUSTOMER. A REVIEW OF THE IABP'S SERVICE HISTORY DOES NOT INDICATE ANY SYSTEMIC ISSUES.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE THE UNIT WAS IN USE ON A PATIENT, THE UNIT GENERATED A "LOW VACUUM" ALARM AND SHUTDOWN. THE UNIT WAS THEN RESTARTED AND GENERATED A "HIGH DRIVE PRESSURE" ALARM AND SHUTDOWN. THE PATIENT WAS SWITCHED TO ANOTHER UNIT AND THERAPY WAS CONTINUED. NO PATIENT INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK