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

Model Number	DRX-REVOLUTION MOBILE X-RAY SYSTEM
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	11/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer site reported that while operating the drx-revolution mobile x-ray system, the site lead tech ran over her right foot, big toe requiring medical attention on (b)(6) 2020.There was no patient involvement.Carestream health has evaluated the device and determined there was no device malfunction, the system is performing as designed and intended.The incident was caused by the user not following the instructions for use (ifu).The site acknowledged and confirmed that the tech was positioned on the side of the system, as opposed to behind the system, and did not use both hands to drive the revolution as specified in the ifu.It is unlikely, if following the driving recommendations provided within the ifu, that this type of injury would occur.Carestream health has concluded this investigation.
Event or Problem Description
While operating the drx revolution system, the site lead tech ran over her right foot, big toe requiring medical attention.The resulting injury was a hair fracture to the right foot, big toe.The toe and nail were dark and bruised.The tech was placed on chair duty to the injury.

• Brand Name: DRX-REVOLUTION MOBILE X-RAY SYSTEM
• Common Device Name: DRX-REVOLUTION MOBILE X-RAY SYSTEM
• Manufacturer (Section D): CARESTREAM HEALTH INC.; 150 verona street; rochester NY 14608
• MDR Report Key: 11033226
• Report Number: 1317307-2020-00010
• Device Sequence Number: 13711653
• Product Code: IZL
• UDI-Device Identifier: 60889971019394
• UDI-Public: 0160889971019394
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K191025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: DRX-REVOLUTION MOBILE X-RAY SYSTEM
• Device Catalogue Number: 1019397
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/04/2020
• Initial Report FDA Received Date: 12/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other