BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM O2 IMAGING SYSTEM

    MDR report key: 19772364 · Received July 18, 2024

    Report

    Report Number
    3006544299-2024-00548
    Event Type
    Malfunction
    Date Received
    July 18, 2024
    Date of Event
    July 16, 2024
    Report Date
    July 26, 2024
    Manufacturer
    SANMINA -SCI SYSTEMS
    Product Code
    OWB
    PMA / PMN Number
    K200074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL PRODUCT ADDED TO D10. CONTINUATION OF D10: PRODUCT ID: BI71000159, LOT NUMBER: UNKNOWN H3, H6: THE SYSTEM WAS SERVICED IN THE FIELD. THE DUAL GANTRY FANS WERE REPLACED. B01, C07, 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.

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: B I71000531, H6: MULTIPLE ANNEX A CODES WERE CODED FOR THIS EVENT. A0406 WAS CODED FOR THE FAN BEING DAMAGED. A0508 WAS CODED FOR THE IMAGING SYSTEM MAKING NOISE. A051203 WAS CODED FOR THE PARTS FALLING OFF THE SYSTEM. A05 WAS CODED FOR THE COVER BEING DAMAGED. H3, H6: NO PRODUCTS WERE RECEIVED BY THE MANUFACTURER FOR 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 AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE CUSTOMER CALLED TO MENTION THEIR IMAGING SYSTEM MADE A LOT OF NOISE WHEN USING IT, AND SOME PARTS WERE FALLING OFF THE IMAGING SYSTEM. THE CUSTOMER STATED THE NOISE HAS BEEN PRESENT SINCE THE LAST PLANNED MAINTENANCE (PM). THE INSIDE GANTRY COVER WAS DAMAGED, THIS DAMAGE CAUSED THE FAN TO BREAK. THE MANUFACTURER REPRESENTATIVE (REP) FOUND A PIECE OF THE FAN INSIDE THE GANTRY. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1918161 O-ARM O2 IMAGING SYSTEM INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB SANMINA -SCI SYSTEMS BI70002000

    Patients

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