BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOSCAN MINI C-ARM X-RAY SYSTEM FD-OR

    MDR report key: 10271325 · Received July 14, 2020

    Report

    Report Number
    3005254598-2020-00001
    Event Type
    Injury
    Date Received
    July 14, 2020
    Date of Event
    April 15, 2020
    Report Date
    June 15, 2020
    Manufacturer
    ORTHOSCAN, INC.
    Product Code
    OXO
    PMA / PMN Number
    K051754
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED A NURSE WAS INJURED WHEN MANIPULATING AN ORTHOSCAN MINI C-ARM. ONE FINGER WAS FRACTURED WHEN THE C-ARM JOINT WAS FOLDING. THE EXACT DATE OF INCIDENT WAS NOT REPORTED, HOWEVER THE REPORTER STATED THE INJURY OCCURED TWO MONTHS PRIOR TO REPORTING TO THE MANUFACTURE. IN THE REVIEW OF PHOTOS RECEIVED FROM THE REPORTER, IT WAS DETERMINED THE FLEX ARM JOINTS WERE MISSING. FURTHER, THE CUSTOMER HAD TAPED HANDWRITTEN SIGNS ON THE UNIT TO WARN USERS OF THE HAZARD. THE MANUFACTURE HAS NO DOCUMENTATION OF ANY CUSTOMER COMPLAINTS REGARDING THE FLEX ARM JOINT COVERS NOR ANY PREVENTATIVE MAINTENANCE DOCUMENTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737121 ORTHOSCAN MINI C-ARM X-RAY SYSTEM FD-OR MINI C-ARM X-RAY SYSTEM FD-OR OXO ORTHOSCAN, INC. 1000-0004

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention