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

Catalog Number	8618894
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Carestream health has evaluated the device and determined there was no device malfunction, and the drx revolution system is performing as designed and intended.It was confirmed that this incident was due to user error by placing a clipboard in the middle of the drive handle of the unit.The incident was caused by the user not following the instructions for use (ifu).It was confirmed that the weight of the clipboard closed the deadman switches in the drive handle and had enough weight to unbalance the drive mechanism.The service personnel communicated to the operators to not insert anything in the space between the handle and the cart, while using the system.The site will also proactively install a bin divider as a precautory measure so that a clipboard cannot be placed in that holder anymore.There are no further actions to be taken by carestream health related to this issue.Carestream has completed this investigation.
Event or Problem Description
On (b)(6) 2023, carestream health (csh) was informed of an incident related to the drx-revolution plus mobile x-ray system.The technologist was on route to a patient's room and parked the unit.However, after letting go of the unit, it drove backwards into the wall.No injuries were reported.

• 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
• Manufacturer (Section G): CARESTREAM HEALTH INC.; 1049 ridge road west; rochester NY 14615
• Manufacturer Contact: alejandra benitez ; 150 verona street; rochester, NY 14608 ; 5856278533
• MDR Report Key: 17919720
• Report Number: 1317307-2023-00010
• Device Sequence Number: 2957191
• Product Code: IZL
• UDI-Device Identifier: 60889978618897
• UDI-Public: (01)60889978618897
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/11/2023

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 Catalogue Number: 8618894
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/19/2023
• Initial Report FDA Received Date: 10/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown