BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOOTSWITCH 1895410 XPS SINGLE FUNCTION

    MDR report key: 2893032 · Received January 2, 2013

    Report

    Report Number
    1045254-2013-00001
    Event Type
    Malfunction
    Date Received
    January 2, 2013
    Date of Event
    November 27, 2012
    Report Date
    December 3, 2012
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    ERL
    PMA / PMN Number
    K963246
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BLANK FIELDS IN THIS REPORT ARE THE RESULT OF INFORMATION NOT PROVIDED BY THE INITIAL REPORTER OR USER FACILITY. THIS PRODUCT IS USED FOR THERAPEUTIC PURPOSES. (B)(4). THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR SERVICE AND REPAIR. THE REPAIR TECHNICIAN FOUND THE CONNECTOR WIRES WERE LOOSE. THE DEVICE WAS REPAIRED AND TESTED TO SPECIFICATIONS AND HAS BEEN RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED TO SERVICE AND REPAIR THAT THE FOOT CONTROL WAS RUNNING CONTINUOUSLY WHEN PLUGGED IN. THERE WAS NO REPORT OF PATIENT IMPACT OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1697 FOOTSWITCH 1895410 XPS SINGLE FUNCTION DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL MEDTRONIC XOMED, INC. 1895410 206043217

    Patients

    Seq Age Sex Outcome Treatment
    1