BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO SCAN MINI C-AM

    MDR report key: 10407391 · Received August 13, 2020

    Report

    Report Number
    MW5096073
    Event Type
    Malfunction
    Date Received
    August 13, 2020
    Date of Event
    August 7, 2020
    Report Date
    August 12, 2020
    Manufacturer
    ORTHO SCAN INC.
    Product Code
    OXO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT SURGERY W/FLUOROSCOPY. RADIOLOGY WENT TO REVIEW THE IMAGES W/PHYSICIAN WHEN PATIENT WAS NOT LISTED ON THE WORKLIST. UNABLE TO VIEW THE IMAGES. THE MONITOR THEN WENT OFF WITH MESSAGE THE MACHINE WAS OUT OF RANGE & THEN THE MACHINE SHUT OFF COMPLETELY. IMAGES LOST. VENDOR NOTIFIED & RECOMMENDED REPLACING THE IMAGE STORAGE DRIVE. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    869748 ORTHO SCAN MINI C-AM IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE OXO ORTHO SCAN INC.

    Patients

    Seq Age Sex Outcome Treatment
    1