BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM O2 IMAGING SYSTEM

    MDR report key: 15052453 · Received July 19, 2022

    Report

    Report Number
    3006544299-2022-00282
    Event Type
    Malfunction
    Date Received
    July 19, 2022
    Date of Event
    July 15, 2022
    Report Date
    July 19, 2022
    Manufacturer
    SANMINA -SCI SYSTEMS
    Product Code
    OWB
    UDI-DI
    00763000355555
    PMA / PMN Number
    K200074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED DURING A SPINAL PROCEDURE. FOLLOWING A PROCEDURE, WHEN THE SURGEON WANTED TO VERIFY PLACEMENT OF THE IMPLANTABLE, THE SCANNED THUMBNAIL IMAGE OF THE IMAGE ACQUISITION SHOWED AS BLACK ON THE MOBILE VIEWING STATION (MVS). WHEN DOUBLE-CLICKING ON THE EXAM, PICTURES OF THE SCAN WOULD LOAD. HOWEVER, WHEN PUSHING THE IMAGES TO PICTURE ARCHIVING AND COMMUNICATION SYSTEMS (PACS), A DIGITAL IMAGING AND COMMUNICATIONS IN MEDICINE (DICOM) ERROR WOULD BE RECEIVED. IT WAS NOTED THE "NAV" TAG WAS PRESENT. SEVERAL OTHER ATTEMPTS WERE MADE TO PUSH THE EXAM WITHOUT RESOLUTION. THE SITE ALSO TRIED TO TAKE A 2D IMAGE ACQUISITION. WHEN ATTEMPTING TO PUSH TO PACS, THE IMAGE THUMBNAIL WAS BLACK AND THE DICOM ERROR WAS ALSO PRESENT. THE DOSE REPORT ALSO FAILED AND WAS COMPLETELY BLACK. FOR FURTHER TROUBLESHOOTING, THE NAVIGATION SYSTEM WAS NOT PRESENT TO PUSH EXAMS. ANOTHER CABLE AND NETWORK PORT WERE ATTEMPTED. THE REPORTED ISSUE DID NOT RESULT IN A PROCEDURE DELAY. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1653594 O-ARM O2 IMAGING SYSTEM INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB SANMINA -SCI SYSTEMS BI70002000 00763000355555

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown