BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CART 9734056 S7 STAFF SHRT 100-120V INTL

    MDR report key: 19974156 · Received August 13, 2024

    Report

    Report Number
    1723170-2024-02136
    Event Type
    Malfunction
    Date Received
    August 13, 2024
    Date of Event
    August 1, 2024
    Report Date
    September 11, 2024
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3, H6) THE PRODUCT ID: 9735225, LOT NUMBER: 1924323 RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE ISSUE WAS CONFIRMED. THE ANALYST REPORTED THEY HAD TO USE THE RESET SWITCH TO START THE COMPUTER. THE BASIC INPUT/OUTPUT SYSTEM (BIOS) WAS SET TO JANUARY 01, 2007. IT ALSO HAD A FAILING / DEAD COMPLEMENTARY METAL OXIDE SEMICONDUCTOR (CMOS) BATTERY. IT WAS NOTED THE ADMIN PROGRAM STARTED AND RAN NORMALLY AND NO ERRORS WERE REPORTED. PREVIOUSLY REPORTED CODES B01, C13, AND D02 ARE APPLICABLE AS WELL AS NEWLY REPORTED CODE, C02. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    SECTION D REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER MEDICAL PRODUCTS IN USE DURING THE EVENT INCLUDE: BRAND NAME ; PRODUCT ID 9734477 (LOT: 1924323); PRODUCT TYPE: 2543-MNAV - SYSTEM H3: THE SYSTEM WAS SERVICED IN THE FIELD AND HARDWARE PARTS WERE REPLACED. CODES B01, C13, D02 ARE APPLICABLE TO THIS ANALYSIS. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT DURING PREPARATION THE PREVIOUS DAY, THE SYSTEM WOULD NOT START AND TURN ON AND DISPLAYED "NO SIGNAL". THE COMPUTER WAS REPLACED, AND NORMAL STARTUP WAS CONFIRMED. NO PATIENT WAS PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1177247 CART 9734056 S7 STAFF SHRT 100-120V INTL NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC 9734056

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE H11...