BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM O2 IMAGING SYSTEM

    MDR report key: 19730678 · Received July 12, 2024

    Report

    Report Number
    3006544299-2024-00528
    Event Type
    Malfunction
    Date Received
    July 12, 2024
    Date of Event
    July 1, 2024
    Report Date
    July 12, 2024
    Manufacturer
    SANMINA -SCI SYSTEMS
    Product Code
    OWB
    UDI-DI
    00763000068066
    PMA / PMN Number
    K200074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: MULTIPLE ANNEX A CODES WERE CODED FOR CODED FOR THIS EVENT. A0709 WAS CODED FOR THE PENDANT SAYING THE GANTRY WAS OPENED WHEN CLOSED. A090501 WAS CODED FOR BEING UNABLE TO TAKE A SPIN. A1102 WAS CODED FOR THE DOOR OPEN WARNING. 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 DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT WHEN THE SITE CLOSED THE GANTRY, THE PENDANT STILL SAID THE GANTRY WAS OPEN SO THEY WERE UNABLE TO TAKE A SPIN. THERE WAS A DOOR OPEN WARNING.  THE SITE OPENED AND CLOSED THE DOOR, AND GENTLY PULLED DOWN ON THE COVER, WHICH RESOLVED THE ISSUE. THERE WAS LESS THAN AN HOUR DELAY IN SURGERY. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315175 O-ARM O2 IMAGING SYSTEM INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB SANMINA -SCI SYSTEMS BI70002000 00763000068066

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male