BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1723170-2019-02646

    MDR report key: 8642879 · Received May 24, 2019

    Report

    Report Number
    1723170-2019-02646
    Event Type
    Malfunction
    Date Received
    May 24, 2019
    Report Date
    May 24, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    PMA / PMN Number
    K001153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE ACC 9680159R TREON PSU (UNKNOWN LOT/SERIAL #) FOUND NO FAILURE AS BOTH DEVICES APPEARED TO BE UNUSED, BUT THE PACKAGE HAD BEEN OPENED FOR EACH ONE. BOTH PSU¿S WERE FOUND TO BE FULLY FUNCTIONAL AND PASSED ACCURACY TESTS. NO PROBLEMS WERE FOUND. [P241744 MANUFACTURE DATE JULY 2004; P241969 MANUFACTURE DATE FEBRUARY 2005] PRODUCT EVENT SUMMARY #CAMERA NOT WORKING PRODUCT ANALYSIS #(B)(4): MNAV COMMENT SUBJECT: WORKORDER (B)(4). MNAV COMMENT ID: (B)(4). MNAV COMMENT: HARDWARE: FAIL; FAILURES: OPTICAL COMMUNICATION; SUMMARY: CAMERA WAS NOT COMMUNICATION WITH COMPUTER.; RESOLVED: YES. MNAV ACTION/RESOLUTION: COMPUTER SOLVED THE ISSUE. SYSTEM READY TO BE USED. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 960-147, SERIAL/LOT #: (B)(4), UDI#: (B)(4); PRODUCT ID: 9680171, SERIAL/LOT #: (B)(4); PRODUCT ID: 9680165, SERIAL/LOT #: (B)(4), UDI#: (B)(4); PRODUCT ID: 9680138, SERIAL/LOT #: (B)(4); PRODUCT ID: 9730744R, SERIAL/LOT #: (B)(4); PRODUCT ID: 9680159R, SERIAL/LOT #: P241744, P241969; PRODUCT ID: 9733575, SERIAL/LOT #: (B)(4); PRODUCT ID: 9733582, SERIAL/LOT #: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    CAMERA NOT WORKING. MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM EVENT HAVING OCCURRED OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT THE CAMERA WASN'T WORKING. ADDITIONAL INFORMATION PROVIDED INCLUDED THE INSTRUMENTS WERE UNABLE TO BE SEEN BY THE CAMERA AND THE LED'S ON THE CAMERA WERE OBSERVED TO BE OFF. NO PATIENT PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436165 HAW MEDTRONIC NAVIGATION, INC 9730749

    Patients

    Seq Age Sex Outcome Treatment
    1