BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM O2 IMAGING SYSTEM

    MDR report key: 20064825 · Received August 26, 2024

    Report

    Report Number
    3006544299-2024-00640
    Event Type
    Malfunction
    Date Received
    August 26, 2024
    Date of Event
    August 13, 2024
    Report Date
    August 26, 2024
    Manufacturer
    SANMINA -SCI SYSTEMS
    Product Code
    OWB
    UDI-DI
    00763000616564
    PMA / PMN Number
    K200074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3, H6: A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. THE PS1 WHICH WAS STEADY AT 5.11 VOLTS. THE LOGS FOUND CU STOMER SUPPLIED ETHERNET CABLE TO POSSIBLY CAUSE CONNECTION TO THE NAVIGATION TO DROP OUT. THE SYTSEM WAS FUNCTIONING NORMALLY. CODES B01, C19 AND D14 ARE APPLICABLE TO THIS ANALYSIS.  A1102 - 3D MODE WAS DISABLED MESSAGE A090501 - NOT ALLOWING THE SYSTEM TO TAKE A 3D SPIN. 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 THE SYSTEM WAS DISPLAYING A MESSAGE STATING 3D MODE WAS DISABLED, AND NOT ALLOWING THE SYSTEM TO TAKE A 3D SPIN. REBOOTING THE SYSTEM SEVERAL TIMES MAY HAVE RESOLVED THE ISSUE TEMPORARILY. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1160207 O-ARM O2 IMAGING SYSTEM INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB SANMINA -SCI SYSTEMS BI70002000 00763000616564

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown