BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 8324204 · Received February 8, 2019

    Report

    Report Number
    3004785967-2019-00217
    Event Type
    Malfunction
    Date Received
    February 8, 2019
    Date of Event
    January 30, 2019
    Report Date
    July 22, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC (LITTLETON)
    Product Code
    OXO
    PMA / PMN Number
    K050996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    H3, H6) THE PCBA BI31000172 PFC BOARD 1000 (LOT # REV. 1 S/N 48-7NS:384) WAS RETURNED FOR ANALYSIS. ANALYSIS CONFIRMED THE REPORTED ISSUE OF "O-ARM 1000 UNABLE TO SHOOT X-RAY INTERMITTENT. REQUIRE TO RESTART SYSTEM IN ORDER TO RESOLVE ISSUE EACH TIME." IT WAS NOTED THAT BENCH TESTING COULD NOT BE STARTED DUE TO AN ELECTRICALLY OVER STRESSED COMPONENT. EVALUATION CODES THAT APPLY TO THIS TESTING: 10, 4203, 4307 H3, H6) THE PCBA BI31000158 MOTION CONTROL PCB (LOT # REV. 1 : S/N MT804895 / G30002) WAS RETURNED FOR ANALYSIS. ANALYSIS WAS UNABLE TO CONFIRM THE COMPLAINT OF "O-ARM 1000 UNABLE TO SHOOT X-RAY INTERMITTENT. REQUIRE TO RESTART SYSTEM IN ORDER TO RESOLVE ISSUE EACH TIME." THE CIRCUIT BOARD WAS INSTALLED IN SYSTEM 267 AND IT FUNCTIONED AS EXPECTED. MOTION, READIED AND MOTION BOOTED, READIED AND RESPONDED APPROPRIATELY. PERFORM MULTIPLE 2D AND 3D IMAGES WITHOUT ISSUE. THERE WAS NO FAULT FOUND. EVALUATION CODES THAT APPLY TO THIS TESTING: 10, 213, 67 H3, H6) THE PCBA BI31000169 BATTERY CHARGER 1 (LOT # REV. 2 : S/N SE10390095) WAS RETURNED FOR ANALYSIS. ANALYSIS WAS UNABLE TO CONFIRM THE COMPLAINT OF "O-ARM 1000 UNABLE TO SHOOT X-RAY INTERMITTENT. REQUIRE TO RESTART SYSTEM IN ORDER TO RESOLVE ISSUE EACH TIME." BATTERY CHARGER-1 PCBA PASSED FUNCTIONAL OUTPUT BENCH TESTING. VISUAL INSPECTION PASSED. INSTALLED BATTERY CHARGER-1 BOARD IN O-ARM SYSTEM 267, THE SYSTEM READIED AND CHARGED AS EXPECTED. MULTIPLE 2D AND 3D IMAGES WERE SUCCESSFUL. NO BATTERY, LOW VOLTAGE OR UNEXPECTED POWER DOWN WHILE UNDER TEST. NO FUNCTIONAL PROBLEM WAS FOUND. EVALUATION CODES THAT APPLY TO THIS TESTING: 10, 213, 67 H3, H6) THE PCBA BI31000170 BATTERY CHARGER 2 (LOT # REV. 2 : S/N S1345XPR) WAS RETURNED FOR ANALYSIS. ANALYSIS CONFIRMED THE REPORTED ISSUE OF "O-ARM 1000 UNABLE TO SHOOT X-RAY INTERMITTENT. REQUIRE TO RESTART SYSTEM IN ORDER TO RESOLVE ISSUE EACH TIME." IT WAS NOTED THAT BENCH TESTING COULD NOT BE STARTED DUE TO AN ELECTRICALLY OVER STRESSED COMPONENT. EVALUATION CODES THAT APPLY TO THIS TESTING: 10, 4203, 4307 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

    INITIAL REPORTER UPDATED. 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.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PFC 1000, BATTERIES, AND BATTERY CHARGERS 1 AND 2 WERE REPLACED.

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. INITIAL REPORTER NOT AVAILABLE ON THE DATE OF FILING. A MANUFACTURER REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. TESTING DETERMINED THAT HARDWARE PARTS NEEDED TO BE REPLACED. THE HARDWARE PARTS WERE REPLACED. THE IMAGING SYSTEM THEN PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL. DEVICE MANUFACTURING DATE IS UNAVAILABLE. 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 IMAGING DEVICE WAS UNABLE TO SHOOT X-RAYS INTERMITTENTLY. A RESTART WAS REQUIRED IN ORDER TO RESOLVE THE ISSUE EACH TIME. TROUBLESHOOTING FOUND THAT PFC 1000, BATTERIES, AND BATTERY CHARGERS 1 AND 2 WERE FAULTY. THE MOST LIKELY CAUSE WAS NOTED TO BE WEAR AND TEAR OF ELECTRICAL BOARDS/PARTS. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112983 O-ARM 1000 IMAGING SYSTEM IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE OXO MEDTRONIC NAVIGATION, INC (LITTLETON) UNK_OARM_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1