BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM O2 IMAGING SYSTEM

    MDR report key: 18959525 · Received March 22, 2024

    Report

    Report Number
    3004785967-2024-00193
    Event Type
    Malfunction
    Date Received
    March 22, 2024
    Date of Event
    February 23, 2024
    Report Date
    March 22, 2024
    Manufacturer
    MEDTRONIC NAVIGATION, INC (LITTLETON)
    Product Code
    OWB
    PMA / PMN Number
    K200074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    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: BI71000183, LOT NUMBER: UNKNOWN ; PRODUCT ID: BI71000194, LOT NUMBER: UNKNOWN ; PRODUCT ID: BI71000162, LOT NUMBER: UNKNOWN ; PRODUCT ID: BI71000163, LOT NUMBER: UNKNOWN ; PRODUCT ID: BI71000166, LOT NUMBER: UNKNOWN G2: FOREIGN COUNTRY - KOREA H3/H6: THE SYSTEM WAS SERVICED AND THE CABLE DOOR ASSEMBLY, HANDSWITCH, PLATE SYSTEM, AND BATTERIES WERE REPLACED. CODES B01, C02, C07, AND D02 APPLY. 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 OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THERE WAS AN ISSUE WITH TAKING IMAGES. THERE WAS NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2275987 O-ARM O2 IMAGING SYSTEM INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB MEDTRONIC NAVIGATION, INC (LITTLETON) BI70002000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown