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

Catalog Number	1019397
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	11/17/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Carestream health has evaluated the device.The investigation determined that the right side load cell failure was due to previous impact(s) or impact(s) with enough force (e.G., user accidentally collides with a wall or other obstruction) to affect the load cell, the cart drive calibration, and the cart driving.This was evidenced by the damaged right side panel and inner handle covers.As a result, the tech obtained a bruise on the leg and arm.It could not be confirmed by the site if medical attention was required.There was no patient involvement.The field engineer replaced the right load cell and successfully performed a cart drive calibration.The cart drive was tested and is now working properly.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 18-nov-2023, carestream health (csh) was informed of an incident related to the drx-revolution mobile x-ray system.The technologist was behind the portable in the hallway outside the patient's room, she tried to drive forward using both hands on the drive handle; however, the unit drove backwards pinning her between the wall and the portable.

• 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: 18310300
• Report Number: 1317307-2023-00011
• Device Sequence Number: 6278570
• Product Code: IZL
• UDI-Device Identifier: 60889971019394
• UDI-Public: 0160889971019394
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/11/2023

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: 1019397
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/18/2023
• Initial Report FDA Received Date: 12/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2018
• 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