BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIGITAL MOBILE OPTIMAX220 PORTABLE X-RAY UNIT

    MDR report key: 12868791 · Received November 23, 2021

    Report

    Report Number
    MW5105544
    Event Type
    Injury
    Date Received
    November 23, 2021
    Date of Event
    November 18, 2021
    Report Date
    November 19, 2021
    Manufacturer
    GE HEALTHCARE / GE MEDICAL SYSTEMS, LLC.
    Product Code
    IZL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    LOSS OF PATIENT IMAGE ON PORTABLE X-RAY MACHINE. PATIENTS HAD TO BE RE-EXPOSED TO ACQUIRE NEW IMAGES. EVENT ON (B)(6) 2021: IMAGE WAS CAPTURED, SYSTEM FROZE AND GAVE ERROR "5200159 (ERROR)" AND "800109 AN INTERNAL SOFTWARE ERROR OCCURRED." PATIENT HAD TO BE RE-IMAGED. EVENT ON (B)(6) 2021: IMAGE WAS CAPTURED, SYSTEM FROZE DURING PROCESSING AND GAVE ERROR "1221049 DIGITAL CASSETTE DETECTOR CRITICAL VOLTAGE SENSOR IS OUT OF RANGE. EXPOSURES ARE INHIBITED." PATIENT HAD TO BE RE-IMAGED. NO KNOWN COMPLICATIONS OR IMPAIRMENTS OUTSIDE OF THE ADDITIONAL (UNNECESSARY) RADIATION EXPOSURE. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1763251 DIGITAL MOBILE OPTIMAX220 PORTABLE X-RAY UNIT SYSTEM, X-RAY, MOBILE IZL GE HEALTHCARE / GE MEDICAL SYSTEMS, LLC. OPTIMA XR220AMX
    1763252 DIGITAL MOBILE OPTIMAX220 PORTABLE X-RAY UNIT SYSTEM, X-RAY, MOBILE IZL GE HEALTHCARE / GE MEDICAL SYSTEMS, LLC. OPTIMA XR220AMX

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown