BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IPUMP PAIN MANAGEMENT SYSTEM US VERSION

    MDR report key: 1030828 · Received April 17, 2008

    Report

    Report Number
    6000001-2008-00249
    Event Type
    Malfunction
    Date Received
    April 17, 2008
    Date of Event
    February 1, 2008
    Report Date
    February 13, 2008
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD
    Product Code
    FRN
    PMA / PMN Number
    K052973
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BY BAXTER. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD THE RESULTS BECOME AVAILABLE. THE MANUFACTURING FACILITY HAS BEEN MADE AWARE OF THIS REPORT THROUGH BAXTER'S COMPLAINT MGMT TRACKING SYSTEM. THE MANUFACTURING FACILITY WILL CONTINUE TO MONITOR SIMILAR REPORTS FOR POSSIBLE TRENDS.

    Description of Event or Problem · 1

    THE FACILITY REP REPORTED NO UPSTREAM OCCLUSION ALARM DURING INCOMING TESTING OF THE DEVICE. NO PT INVOLVEMENT WAS REPORTED. THE DEVICE WAS SENT TO BAXTER FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IPUMP PAIN MANAGEMENT SYSTEM US VERSION 80FRN FRN BAXTER HEALTHCARE PTE. LTD NA

    Patients

    Seq Age Sex Outcome Treatment
    1