BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIELD GENERATOR 9731203 EM MOBILE

    MDR report key: 8665250 · Received June 4, 2019

    Report

    Report Number
    1723170-2019-02903
    Event Type
    Malfunction
    Date Received
    June 4, 2019
    Report Date
    June 3, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    PMA / PMN Number
    K001284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE CART (B)(4) FUSION EM SYSTEM (SERIAL #: (B)(4)) FOUND NO FAILURE, AS IT PASSED THE WORK ORDER. ANALYSIS OF THE FIELD GENERATOR (B)(4) EM MOBILE (LOT #: 0400003241) FOUND NO FAULT, AS THE REPORTED PROBLEM COULD NOT BE DUPLICATED. THE FIELD GENERATOR WAS CONNECTED TO A TEST SYSTEM FOR AN OVERNIGHT BURN-IN TEST. THE SYSTEM REMAINED IN GREEN STATUS DURING ALL TESTING. FLEXING THE CABLE DOES NOT INDICATE ANY INTERMITTENT OPENS. FULLY FUNCTIONAL. PRODUCT EVENT SUMMARY: DAMAGED EMITTER PRODUCT ANALYSIS #(B)(4). FINDINGS AND CONCLUSIONS: REPORTED PROBLEM COULD NOT BE DUPLICATED. THE FIELD GENERATOR WAS CONNECTED TO A TEST SYSTEM FOR AN OVERNIGHT BURN-IN TEST. THE SYSTEM REMAINED IN GREEN STATUS DURING ALL TESTING. FLEXING THE CABLE DOES NOT INDICATE ANY INTERMITTENT OPENS. FULLY FUNCTIONAL. METHODOLOGY: FUNCTIONAL TESTING;VISUAL/PHYSICAL EXAMINATION. DETAIL: AWAITING FIELD RESPONSE/INFO. USABILITY: FALSE. ABLE TO DUPLICATE THE ISSUE?: NO. FAILURE MODE: NO FAULT FOUND. PRODUCT ID: 9733560XOM, SERIAL/LOT #: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM EVENT HAVING OCCURRED OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT THE AXIEM BOX AND EMITTER WERE IN RED STATUS IN THE EMITTER TRACKING DETAILS. NO PATIENT PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460793 FIELD GENERATOR 9731203 EM MOBILE INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9731203 0400003241

    Patients

    Seq Age Sex Outcome Treatment
    1