BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 3RD EDITION IMAGING SYSTEM

    MDR report key: 8156065 · Received December 12, 2018

    Report

    Report Number
    3004785967-2018-00589
    Event Type
    Malfunction
    Date Received
    December 12, 2018
    Date of Event
    November 30, 2018
    Report Date
    March 21, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC (LITTLETON)
    Product Code
    OXO
    UDI-DI
    00643169353428
    PMA / PMN Number
    K092564
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: PATIENT DEMOGRAPHICS UPDATED. PATIENT WEIGHT NOT AVAILABLE FROM THE SITE. INITIAL REPORTER UPDATED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    PRODUCT ANALYSIS # (B)(4): (B)(4) / (B)(4) 2018 / AUTO CREATED FROM WORK ORDER (B)(4) / STATUS UPDATED FROM IN PROCESS TO COMPLETED DATE COMPLETED UPDATED FROM NULL TO 2018-12-04. IMAGE QUALITY UPDATED FROM NULL TO PASS ELECTRICAL INSPECTION. UPDATED FROM NULL TO PASS COMPLIANCE TESTING. UPDATED FROM NULL TO PASS O-ARM IMAGE TRANSFERS TO STEALTH. UPDATED FROM NULL TO PASS ACCURATE NAVIGATION ON O-ARM IMAGE. UPDATED FROM NULL TO PASS MECHANICAL TESTS. UPDATED FROM NULL TO PASS VISUALLY INSPECTED PARTS PRIOR TO INSTALL. UPDATED FROM NULL TO PASS CABLE GRADE. UPDATED FROM NULL TO A LASER TEST. UPDATED FROM NULL TO PASS CONTACT. UPDATED FROM NULL TO LIZ RAMIREZ SYSTEM INSPECTION. UPDATED FROM NULL TO PASS. DOES THE SYSTEM PERFORM AS INTENDED? UPDATED FROM NULL TO YES. WERE HARDWARE PARTS REPLACED? UPDATED FROM NULL TO YES. ACTION/RESOLUTION UPDATED FROM NULL TO REPLACED MOTION AND X-RAY BATTERIES. PERFORMED PM PROCEDURE. SYSTEM FUNCTIONS WITHIN SPECIFICATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: PER SOP-CPA-05, IT WAS DETERMINED THERE WAS AN ACCIDENTAL RADIATION OCCURRENCE DUE TO SYSTEM UNRESPONSIVE. NO DEFECT IN AN ELECTRONIC PRODUCT OR FAILURE TO COMPLY PER 21 CFR 1003 WAS DISCOVERED. THE INVESTIGATION CONCLUDED THAT THE ISSUE WAS DUE TO HARDWARE. MOTION AND X-RAY BATTERIES COMPONENT REPLACED TO RESOLVE. NUMBER OF PEOPLE EXPOSED: 1 - PATIENT NUMBER OF PEOPLE IN OR OTHER THAN PATIENT: 1 (CS) ESTIMATED 3D DOSE ABSORBED (PATIENT): 6.123 MSV. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    FURTHER FOLLOW-UP DETERMINED THAT THE PATIENT WAS PRESENT DURING THE CASE.

    Description of Event or Problem · 0

    ADDITIONAL FOLLOW-UP WITH THE MANUFACTURER REPRESENTATIVE (REP) DETERMINED THAT THE PROCEDURE TYPE WAS A POSTERIOR SPINE FUSION AND THE DELAY IN SURGERY WAS APPROXIMATELY 20-30 MINUTES AND THE SURGERY WAS THEN POSTPONED FOR A LATER DATE. THE REP FURTHER REPORTED THAT THERE WAS ONE UNUSED SPINE IN THE LOWER LUMBAR REGION.

    Additional Manufacturer Narrative · 1

    A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. TESTING REVEALED THAT THE ISSUE WAS DUE TO THE BATTERIES. THE MOTION AND X-RAY BATTERIES WERE REPLACED. ONCE THE BATTERIES WERE REPLACED, THE IMAGING SYSTEM THEN PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL. NO DEVICES WERE RETURNED TO THE MANUFACTURER FOR ANALYSIS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING DEVICE BEING USED OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT AFTER A SUCCESSFUL 3D SPIN, THE SITE COULD NOT GET THE TUBE AND DETECTOR TO ROTATE TO TAKE 2D SCOUTS NOR TAKE A SUCCESSFUL 3D SPIN. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    997530 O-ARM 1000 3RD EDITION IMAGING SYSTEM IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE OXO MEDTRONIC NAVIGATION, INC (LITTLETON) BI70000028120 00643169353428

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR