BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM 3RD EDITION

    MDR report key: 11028425 · Received December 17, 2020

    Report

    Report Number
    3004785967-2020-01528
    Event Type
    Malfunction
    Date Received
    December 17, 2020
    Date of Event
    November 20, 2020
    Report Date
    March 30, 2021
    Manufacturer
    MEDTRONIC INC
    Product Code
    OXO
    PMA / PMN Number
    K173664
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H2) ADDITIONAL INFORMATION RECEIVED MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    H3) THE MANUFACTURER REPRESENTATIVE WENT TO THE SITE TO TEST THE NAVIGATION SYSTEM. THE SYSTEM WAS PERFORMING AS INTENDED AND NO PARTS WERE REPLACED. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE SYSTEM WAS WITHOUT MECHANICAL DAMAGE. THERE WERE SOME CHIPS ON THE SURFACE OF THE GANTRY AND DENTS ON THE PROTECTIVE COVER OF THE HYDRAULIC UNIT. BUT THERE WAS NO TRACES OF SPILLED LIQUIDS ON THE GANTRY COVERS. THE EXTERNAL DAMAGE TO THE INSULATION OF WIRES WAS OBSERVED. THE "IKT" DID NOT TURN OFF FOR 1 MONTH. THE WHEELS WERE WITHOUT CHIPS OR DENTS. THE MOVEMENTS WERE SMOOTH AND THE PENDANT WAS NOT WORN OUT. THE CONTROL PANEL FOR SCANNING MODES WERE CHIPPED. DURING THE PROCESS OF LEARNING HOW THE IMAGING SYSTEM WORKS WITH THE NAVIGATION SYSTEM. THE SITE STATED THAT THE IMAGING SYSTEM IKT DID NOT TURN OFF. THE POWER TOGGLE SWITCH IN THE PERIOD FROM 10/23/2020 - 11/13/2020, ACCORDING TO THE APPLICATION TURNING OFF THE POWER SWITCH COULD LEAD TO AN IMPOSSIBILITY OF SUBSEQUENT INCLUSION. THE DEVICE WAS TURNED OFF WITH A TOGGLE SWITCH. WHEN TURNED ON AGAIN, THE DEVICE INDICATED THE IMPOSSIBILITY OF LOADING THE LOGIC OF GENERATOR. A DETAILED ANALYSIS OF THE EVENT LOG REVEALED A DOWNLOAD FAILURE GENERATOR POWER CIRCUIT CONTROL SOFTWARE. RE-FLASHING OF THE POWER MANAGEMENT BOARD WAS PERFORMED. SUBSYSTEM SETTINGS WERE RESTORED. AFTER REBOOTING THE SYSTEM AND MONITORING THE STATES OF THE PAXSCAN WAS BLOCKED. A YELLOW INDICATOR OF THE CONNECTION OF THE OPTICAL FIBER LINE OF THE DETECTOR (IN THE INDICATOR IS GREEN!). THE CONNECTION HAD BEEN VERIFIED. NO VIOLATIONS WERE FOUND. THE SCANNER WAS RESTARTED IN ORDER TO MEASURE THE VOLTAGES ON THE CONTROL GENERATOR CIRCUIT RELAY. ON PINS 3 AND 4 RELATIVE TO GROUND, VOLTAGE 205 VDC AT EACH. THE RELAY WAS PERMANENTLY CLOSED. NORMALLY, WHEN THE DEVICE IS TURNED OFF, 205 VDC SHOULD BE PRESENT AT CONTACTS 1 AND 2 (RELAY IS OPEN), AND ONLY WHEN THE RELAY IS CONTROLLED PULSE 24 VDC FROM THE POWER CONTROL BOARD, THE RELAY SHOULD CLOSE ACTIVATING THE GENERATOR CIRCUIT. THIS MALFUNCTION MAY AFFECT DISCONNECTING THE GENERATOR CIRCUIT, WHICH WILL SUBSEQUENTLY LEAD TO FAILURES IN SUBSYSTEM OPERATION. OVERHEATING OF ELECTRONIC COMPONENTS MAY EMIT FAILURE OF THE ROM WITH THE CONTROL PARAMETERS OF THE SU BSYSTEMS WHICH WILL LEAD TO FIRMWARE FAILURE OR COMPLETE COMPONENT FAILURE DESCRIBED ABOVE. THE RELAY FOR CONTROLLING THE GENERATOR CIRCUIT MUST BE REPLACED. AFTER FLASHING THE CONTROL COMPONENTS AND MONITORING THE INTERNAL ICT CONNECTIONS STARTED UP NORMALLY. BASED ON THE RESULTS OF TECHNICAL CHECKS AND MAINTENANCE WORK THE IMAGING SYSTEM IN A TECHNICALLY SOUND CONDITION. CRITICAL VIOLATIONS IN THE OPERATION OF THE SUBSYSTEMS WAS NOT REVEALED. EXTERNAL CONTROLS ARE IN SATISFACTORY CONDITION. CALIBRATED FLURO GAIN CALIBRATION AND RAD CALIBRATION. RECOMMENDATIONS FOR USE: DO NOT CALIBRATE THE ICT MOVEMENT WITHOUT A MANUFACTURER REPRESENTATIVE PRESENT. CONDUCT FLURO GAIN CALIBRATION AS REQUESTED BY THE SYSTEMS. DO NOT PERFORM RAD CALIBRATION AS REQUESTED BY THE SYSTEM. AT THE END OF THE WORKING DAY, TURN OFF THE SYSTEM BY REGULAR SWITCHES. DO NOT DISCONNECT MOBILE VIEW STATION (MVS) FROM THE SOCKET.

    Additional Manufacturer Narrative · 1

    ONSITE FUNCTIONAL AND VISUAL EXAMINATION WAS PERFORMED BY A MANUFACTURER REPRESENTATIVE. THE ISSUE INDICATED TO BE CAUSED BY AN ISSUE WITH THE POWER TRAIN OF THE SYSTEM. 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 A PROCEDURE. IT WAS REPORTED THAT THE SYSTEM DID NOT TURN ON AFTER RESTART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1497042 O-ARM 1000 IMAGING SYSTEM 3RD EDITION IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE OXO MEDTRONIC INC BI70000027230

    Patients

    Seq Age Sex Outcome Treatment
    1