BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1083420 · Received July 11, 2008

    Report

    Report Number
    1083420
    Event Type
    Malfunction
    Date Received
    July 11, 2008
    Date of Event
    July 1, 2008
    Report Date
    July 11, 2008
    Manufacturer
    DATASCOPE CORPORATION
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    RN RESPONDED TO IABP ALARM "LOW BATTERY", DESPITE MACHINE PLUGGED IN. CHANGED OUTLET, TROUBLESHOOTING MEASURES PERFORMED, PERFUSIONIST ON CALL PAGED, DATASCOPE HELP LINE CALLED AND UNABLE TO ASSIST WITH PROBLEM.====================== MANUFACTURER RESPONSE FOR INTRAAORTIC BALLOON PUMP, (BRAND NOT PROVIDED)======================THEY WILL BE SENDING REPLACEMENT PARTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORPORATION CS 300 *

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR