MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC OPTIMA; SYSTEM, X-RAY, MOBILE

Model Number	XR200AMX
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/26/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Ge optima portable xr machine started developing "barcode artifact" on patient images.Images were still diagnostic as artifact was not over tissue or body part but only in free air areas of exposure.Initial physics testing was on survey date prior to patient use and all items did pass.

• Brand Name: OPTIMA
• Common Device Name: SYSTEM, X-RAY, MOBILE
• Manufacturer (Section D): GE MEDICAL SYSTEMS, LLC; 3000 n grandview blvd.; waukesha WI 53188
• MDR Report Key: 9103363
• Report Number: 9103363
• Device Sequence Number: 16637136
• Product Code: IZL
• UDI-Device Identifier: 00840682115278
• UDI-Public: (01)00840682115278
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 08/27/2019
• Report Date (Section F): 08/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: XR200AMX
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/23/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 74
• Date Report Sent to FDA: 08/27/2019