BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION MPI

    MDR report key: 9940481 · Received April 8, 2020

    Report

    Report Number
    2126677-2020-00003
    Event Type
    Malfunction
    Date Received
    April 8, 2020
    Date of Event
    March 11, 2020
    Report Date
    May 4, 2020
    Manufacturer
    NRT - NORDISK RONTGEN TEKNIK A/S
    Product Code
    JAA
    PMA / PMN Number
    K033486
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER OF THE PRECISION MPI SYSTEM NRT X-RAY A/S HAS COMPLETED THEIR INVESTIGATION AND THE ROOT CAUSE WAS DETERMINED TO BE OPERATOR ERROR AS THE OPERATOR OF THE DEVICE UNINTENTIONALLY DROVE THE C-ARM ONTO A MOVEABLE FLOOR STANDING X-RAY SHIELD. THIS X-RAY SHIELD IS NOT CONSIDERED TO BE PART OF THE PRECISION MPI SYSTEM. THE COLLISION CAUSED THE IMAGE INTENSIFIER TO DETACH FROM THE C-ARM MOUNTING PLATE BUT WAS HELD HANGING BY THE IMAGE INTENSIFIER ELEVATOR DRIVE CHAIN. NEITHER THE PATIENT NOR OPERATOR WAS HARMED. TO CORRECT THE SYSTEM, THE GE FIELD ENGINEER REPLACED THE IMAGE INTENSIFIER ELEVATOR ASSEMBLY. IN ADDITION, ACCORDING TO THE PRECISION MPI OPERATORÂS MANUAL, THERE ARE MULTIPLE WARNINGS TO THE OPERATOR REGARDING COLLISIONS WHEN COMMANDING THE MOVEMENT OF THE C-ARM. THESE WARNING WERE ALSO REVIEWED WITH THE OPERATOR. NO FURTHER ACTIONS ARE NEEDED.

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE MANUFACTURERS INVESTIGATION. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    ON (B)(6) 2020, THE RADIOGRAPHIC TECHNOLOGIST (RT) AT (B)(6) REPORTED THAT AS THEY WERE COMMANDING THE MOVEMENT OF THE POSITIONING C-ARM ON THEIR PRECISION MPI FLUOROSCOPIC SYSTEM DOWNWARD, THEY IMPACTED A MOVEABLE GLASS SHIELD STAND WHICH CAUSED THE IMAGE INTENSIFIER TO DETACH FROM THE IMAGE INTENSIFIER LIFT ASSEMBLY. THERE WAS A PATIENT PRESENT, BUT THEY WERE NOT IMPACTED WHEN THE IMAGE INTENSIFIER DETACHED. THERE WAS NO INJURY RELATED TO THIS EVENT. THIS PRODUCT IS NOT MANUFACTURED BY GE HEALTHCARE. GE HEALTHCARE IS THE IMPORTER OF THE PRECISION MPI SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400360 PRECISION MPI SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-I JAA NRT - NORDISK RONTGEN TEKNIK A/S XRF141

    Patients

    Seq Age Sex Outcome Treatment
    1