BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CART 9734056 S7 STAFF SHRT 100-120V INTL

    MDR report key: 8887987 · Received August 13, 2019

    Report

    Report Number
    1723170-2019-04461
    Event Type
    Malfunction
    Date Received
    August 13, 2019
    Date of Event
    July 19, 2019
    Report Date
    August 13, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICES WERE RETURNED TO THE MANUFACTURER FOR ANALYSIS. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 9733438, SERIAL/LOT #: (B)(4), SYSTEM CONTROL UNIT (SCU). 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 DEVICE BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SYSTEM CONTROL UNIT (SCU) WAS SCHEDULED TO BE REPLACED, BUT THE LAMP OF THE SUBSTITUTE SCU FLASHED ORANGE. THE SCU OF THE HOSPITAL WAS USED AGAIN. THERE WAS NO PATIENT PRESENT AT THE TIME OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680816 CART 9734056 S7 STAFF SHRT 100-120V INTL INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9734056

    Patients

    Seq Age Sex Outcome Treatment
    1