BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 20026092 · Received August 22, 2024

    Report

    Report Number
    3004785967-2024-00497
    Event Type
    Malfunction
    Date Received
    August 22, 2024
    Date of Event
    May 20, 2024
    Report Date
    August 20, 2024
    Manufacturer
    MEDTRONIC NAVIGATION, INC (LITTLETON)
    Product Code
    OXO
    PMA / PMN Number
    K050996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: BI71000850, LOT #: 2062933 REV. 3,. A1-5: SELECT PATIENT INFORMATION CANNOT BE PROVIDED DUE TO REGIONAL PRIVACY REGULATIONS. H3, H6) THE SYSTEM WAS SERVICED IN THE FIELD. IN SUMMARY, HARDWARE PARTS WERE REPLACED. CODES B01 C19, AND D15 ARE APPLICABLE. H3, H6) THE PRODUCT ID: BI71000850, LOT #: 2062933 REV. 3, WAS RETURNED AND ANALYSIS CONFIRMED THE REPORTED EVENT. THE OPERATING SYSTEM (OS) AND THE IMAGING SYSTEM'S APPLICATION FAILED TO LOAD. THE BASIC INPUT/OUTPUT SYSTEM (BIOS) (TIME AND DATE) WAS INCORRECT, THERE WAS A COMPLEMENTARY METAL OXIDE SEMICONDUCTOR (CMOS) BATTERY CHECKSUM ERROR, AND THE 'F1' KEY NEEDED TO BE PRESSED TO CONTINUE THE BOOT UP PROCESS. CODES B01, C13, AND D02 ARE APPLICABLE. 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 AN IMAGING SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE IMAGE ACQUISITION SYSTEM (IAS) DID NOT START UP AND IT WAS THE SAME AFTER RESTARTING. THE USE OF THE MEDTRONIC IMAGING SYSTEM WAS DISCONTINUED AS A RESULT. THERE WAS NO KNOWN IMPACT TO PATIENT'S OUTCOME AND SURGICAL DELAY WAS NOT PROVIDED. ADDITIONAL INFORMATION WAS RECEIVED. A C-ARM WAS USED TO CONTINUE THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2358350 O-ARM 1000 IMAGING SYSTEM IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, M OXO MEDTRONIC NAVIGATION, INC (LITTLETON) BI70000027100

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown