BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IPUMP PAIN MANAGEMENT SYSTEMUS VERSION

    MDR report key: 1243117 · Received November 21, 2008

    Report

    Report Number
    6000001-2008-00777
    Event Type
    Malfunction
    Date Received
    November 21, 2008
    Date of Event
    October 22, 2008
    Report Date
    November 3, 2008
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    MEA
    PMA / PMN Number
    K926385
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE HAS BEEN RECEIVED IN BAXTER AND IS BEING EVALUATED. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE FACILITY REPORTED A PUMP THAT SHUTS DOWN DURING PROGRAMMING. THIS EVENT OCCURRED DURING BIO-MED TESTING. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION NECESSARY ACCORDING TO THE HOSPITAL REPRESENTATIVE. NO ADDITIONAL INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IPUMP PAIN MANAGEMENT SYSTEMUS VERSION 80FRN MEA BAXTER HEALTHCARE CORP NA

    Patients

    Seq Age Sex Outcome Treatment
    1