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	Insufficient Information (4580)
Date of Event	04/05/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Problems with the drx-revolution mobile x-ray system started with patient images not saving in correct patient exam after exposure.X-ray tech was able to find correct patient image in incorrect patients folder.Carestream health was notified by biomedical team and was onsite to diagnose the issue.Log files were downloaded and sent to carestream national support team to determine possible cause of issue.Setting changes, recommended by national support, were made on the devices.Errors continued.Carestream was present daily with on-going trouble shooting.Error escalated up through executive team.Two weeks on going with no resolution.Same error on portable at sister hospital, only commonality is that both portables are first generation revolution with same software versions.

• 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: 11768814
• Report Number: 11768814
• Device Sequence Number: 19833220
• Product Code: IZL
• UDI-Device Identifier: 60889971019394
• UDI-Public: (01)60889971019394
• 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: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 04/28/2021
• Report Date (Section F): 04/28/2021

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: DRX-REVOLUTION MOBILE X-RAY SYSTEM
• Device Catalogue Number: 1019397
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/04/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 04/28/2021