BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM O2 IMAGING SYSTEM

    MDR report key: 8864270 · Received August 6, 2019

    Report

    Report Number
    3004785967-2019-01385
    Event Type
    Malfunction
    Date Received
    August 6, 2019
    Date of Event
    August 1, 2019
    Report Date
    September 27, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC (LITTLETON)
    Product Code
    OWB
    UDI-DI
    00643169639683
    PMA / PMN Number
    K151000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: CONCOMITANT MEDICAL PRODUCTS: OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: BI71000162, SERIAL/LOT #: (B)(4) : S/N N/A, UBD: UNKNOWN, UDI#: UNKNOWN. PRODUCT ID: BI71000163, SERIAL/LOT #: (B)(4) : S/N N/A, UBD: UNKNOWN, UDI#: UNKNOWN. THE BATTERY TRAYS WERE RETURNED TO THE MANUFACTURER FOR ANALYSIS. ANALYSIS FOUND THAT THE REPORTED ISSUE COULD BE CONFIRMED. VISUAL INSPECTION NOTED SCUFFS AND SCRATCHES CONSISTENT WITH NORMAL USE. ON ONE TRAY, THE FIRST BATTERY EXHIBITS EXPANSION AND THE POSITIVE TERMINAL WAS RAISED. THE SECOND BATTERY EXHIBITED MELTING AND EOS AT THE SEAM. BENCH TESTING WAS PERFORMED AT NORMAL ROOM TEMPERATURE. THE BATTERY PAIR MEASURED 13.17VDC AND 13.14VDC (EOS BATTERY). TOTAL VOLTAGE MEASURED 26.31VDC. TESTED ALL FUSES, PASSED CONTINUITY TESTING. ON THE SECOND TRAY, THE THIRD BATTERY EXHIBITS MELTING AND EOS AT THE SEAM. BENCH TESTING WAS PERFORMED AT NORMAL ROOM TEMPERATURE. FIRST BATTERY PAIR MEASURED 13.17VDC AND 13.13VDC. THE SECOND BATTERY PAIR MEASURED 10.44VDC (EOS BATTERY) AND 12.83VDC. TOTAL VOLTAGE MEASURED 49.58VDC. TESTED ALL FUSES, PASSED CONTINUITY TESTING. ANALYSIS FOUND THAT THE REPORTED EVENT WAS RELATED TO AN ELECTRICAL ISSUE. 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 · 1

    A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. TESTING REVEALED THAT THERE WAS A BURNT BATTERY. THE BATTERY TRAY WAS REPLACED. THE IMAGING SYSTEM THEN PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL. NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: AN UPDATE WAS PROVIDED FROM THE FIELD SERVICE ENGINEER THAT A BATTERY TRAY WAS LEAKING AND BURNED A LITTLE BIT. TWO BATTERY TRAYS HAVE BEEN RECEIVED BY THE MANUFACTURER. HOWEVER, ANALYSIS HAS NOT BEEN COMPLETED. 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 SYSTEM. IT WAS REPORTED THAT THE SITE SMELLED A BURNING BATTERY SMELL. A MANUFACTURER REPRESENTATIVE TOLD THE SITE TO UNPLUG THE SYSTEM FROM THE OUTLET. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661437 O-ARM O2 IMAGING SYSTEM INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB MEDTRONIC NAVIGATION, INC (LITTLETON) BI70002000 00643169639683

    Patients

    Seq Age Sex Outcome Treatment
    1