BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS100

    MDR report key: 2072831 · Received March 31, 2011

    Report

    Report Number
    2249723-2011-00020
    Event Type
    Malfunction
    Date Received
    March 31, 2011
    Date of Event
    January 14, 2011
    Report Date
    January 14, 2011
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP REVIEWED THE FAULT LOGS AND FOUND A FAULT CODE 65 (SAFETY VENT FAILURE). THE COMPANY REP REPLACED THE SAFETY VENT VALVE K6A ((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 PT, THE UNIT SHUTDOWN. THE PT WAS SWITCHED TO ANOTHER UNIT AND THERAPY WAS CONTINUED. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CS100 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP. CS100

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK