BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 12705278 · Received October 27, 2021

    Report

    Report Number
    3004785967-2021-01226
    Event Type
    Malfunction
    Date Received
    October 27, 2021
    Date of Event
    October 6, 2021
    Report Date
    October 27, 2021
    Manufacturer
    MEDTRONIC NAVIGATION, INC (LITTLETON)
    Product Code
    OXO
    PMA / PMN Number
    K092564
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE SYSTEM. NEEDED INNER COVERS AND LOWER DOOR CAP. REPLACED INNER DOOR COVERS, LOWER DOOR CAP WASN'T THERE. THE SYSTEM THEN PASSED THE SYSTEM CHECKOUT AND PERFORMED AS INTENDED. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: BI71000493(KIT SVC COVER LWR DOOR CAP) THE FOLLOWING CODES APPLY TO PRODUCT ID: BI71000493 (KIT SVC COVER LWR DOOR CAP). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ON (B)(6) 2021 SALESFORCE (B)(4) (HCP): MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE PATIENT BED HIT THE GANTRY AND COVERS CRACKED. THE GANTRY WAS UNABLE TO OPEN DUE TO THE DAMAGE TO THE SYSTEM. ADDITIONAL INFORMATION RECEIVED, IT WAS REPORTED THAT THE INNER 135° COVER WAS BROKEN ALSO DUE TO HITTING THE BED. THERE WAS NO PATIENT PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1601454 O-ARM 1000 IMAGING SYSTEM IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, M OXO MEDTRONIC NAVIGATION, INC (LITTLETON) BI70000027120

    Patients

    Seq Age Sex Outcome Treatment
    1