MAUDE Adverse Event Report: CARESTREAM HEALTH, INC. DRX-REVOLUTION MOBILE X-RAY SYSTEM; SYSTEM, X-RAY, MOBILE

Model Number	DRX-REVOLUTION MOBILE X-RAY SYSTEM
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Tech went to take x-ray on patient.When images displayed on the screen, they were from another patient from another facility.It was caught and the correct images were displayed on the correct patient.

• Brand Name: DRX-REVOLUTION MOBILE X-RAY SYSTEM
• Common Device Name: SYSTEM, X-RAY, MOBILE
• Manufacturer (Section D): CARESTREAM HEALTH, INC.; 1049 west ridge road; rochester NY 14615
• MDR Report Key: 16814600
• Report Number: 16814600
• Device Sequence Number: 5733924
• Product Code: IZL
• UDI-Device Identifier: 60889978618897
• UDI-Public: (01)60889978618897
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/24/2023
• Report Date (Section F): 04/25/2023

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: Other
• Device Model Number: DRX-REVOLUTION MOBILE X-RAY SYSTEM
• Device Catalogue Number: 8618894
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/26/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/26/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 62 KG
• Patient Race: White
• Date Report Sent to FDA: 04/25/2023