BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS100

    MDR report key: 2191855 · Received July 29, 2011

    Report

    Report Number
    2249723-2011-00105
    Event Type
    Malfunction
    Date Received
    July 29, 2011
    Date of Event
    May 14, 2011
    Report Date
    May 16, 2011
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE REVIEWED THE ERROR LOGS, AND CONFIRMED THAT FAULT CODE 65 (SAFETY VENT FAILURE) WAS DOCUMENTED IN THE ERROR LOGS. HE REPLACED THE K6A SAFETY VENT VALVE (PART NUMBER 0119-00-0170). THE UNIT WAS TESTED TO FACTORY SPECIFICATION. IT FUNCTIONED NORMALLY AND WAS RETURNED TO THE CUSTOMER. A REVIEW OF THE DEVICE'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 DISPLAYED ELECTRICAL FAILURE 65, SYSTEM FAILURE, AND PUMPING STOPPED. THE CUSTOMER RECYCLED POWER TO THE PUMP AND THEY WERE ABLE TO RESUME THERAPY. THE PT EXPIRED; HOWEVER, THEY DO NOT ATTRIBUTE THE PT'S DEATH TO THE FAILURE OF THE PUMP.

    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 Death