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	Pain (1994)
Date of Event	05/05/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2023, carestream health inc.Was informed about incident while driving the drx revolution system.The technologist was on route to do an exam when she reached to hold the automatic door open with one hand and backed up the mobile with the other hand.As the technologist was reversing the mobile, it quickly accelerated and pinned her against the wall.As a result, the tech experienced pain in her right hip and she was limping.She had ice on her hip and was directed to go visit a doctor for a follow up visit.She was sent home for the day.There was no patient involvement.
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 while driving the system with one hand positioned at the edge of the drive handle compressing the side covers; at the same time, the other hand was used to hold open.The incident was caused by the user not following the instructions for use (ifu).The site contact confirmed that the tech did not use both hands while driving the drx revolution system.The service personnel communicated to the operators to use both hands, per the instructions for use (ifu), while driving the system.The site will also re-enforce techs training to not push drive handle on edge compressing the side covers.Carestream has completed this investigation.

• 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: 17008043
• Report Number: 1317307-2023-00006
• Device Sequence Number: 7538425
• Product Code: IZL
• UDI-Device Identifier: 60889978618897
• UDI-Public: 0160889978618897
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/23/2023

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: 05/05/2023
• Initial Report FDA Received Date: 05/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2020
• Is the Device Labeled for Single Use? (Y/N): No
• 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