BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS100

    MDR report key: 1182317 · Received September 30, 2008

    Report

    Report Number
    2221819-2008-00052
    Event Type
    Malfunction
    Date Received
    September 30, 2008
    Date of Event
    June 27, 2008
    Report Date
    July 15, 2008
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A DATASCOPE SERVICE REPRESENTATIVE TESTED THE UNIT. HE RAN IT FOR FIFTY HOURS, AND THE REPORTED PROBLEM COULD NOT BE DUPLICATED OR CONFIRMED. THE SYSTEM ERROR LOGS FOR THE DAY OF THE EVENT IN QUESTION DO NOT CONTAIN ANY ELECTRICAL FAILURES; HOWEVER, FOUR "CHECK IAB CATHETER" MESSAGES ARE LOGGED. THIS TYPE OF ERROR MESSAGE INDICATES A CATHETER ISSUE THAT CAN STOP PUMPING; HOWEVER, IT WOULD NOT RESULT IN A SYSTEM SHUTDOWN. THE UNIT IS BEING RETURNED TO THE FACTORY FOR FURTHER INVESTIGATION. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE FACILITY, ADVISED THAT A CUSTOMER HAD REPORTED THAT WHILE THE PUMP WAS IN USE ON A PT, THE UNIT POWERED DOWN. THE PUMP WAS SWITCHED ON AGAIN. IT RAN FOR A WHILE, BEFORE POWERING DOWN AGAIN. THIS HAPPENED REPEATEDLY AND WAS DUPLICATED BY THE CUSTOMER'S BIOMED. THE PUMP WAS PLUGGED INTO AN AC OUTLET AT THE TIME OF THE EVENT. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CS100 IABP DSP DATASCOPE CORP. CS100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK