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

Model Number	DRX-Revolution Mobile X-ray System
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Bruise/Contusion (1754)
Date of Event	04/02/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2022, carestream health (csh) was informed of an incident related to the drx-revolution mobile x-ray system which occurred at south east health- us.The site reported that a rad tech was backing the revolution plus portable out of the patient room and the unit suddenly backed up pinning her arm against the wall.Her arm was sore and bruised.The tech went to the emergency room for an x-ray of her elbow which showed no broken bones.The injury consisted of a sore and bruised arm.There was no patient involvement.
Additional Manufacturer Narrative
This investigation was conducted by the dealer, service provider in conjunction with carestream support.Based on the investigation and facts presented by the dealer fe, it is unclear what the problem or root cause was in this case as the dealer could not provide additional details regarding the issue or how the tech was driving the system at the time of the incident.The dealer replaced several components related to the drive system: strain gauges, multi access board and performed cart calibrations which provided a smoother drive; however, it is unknown if these were warranted as he could not reproduce the initial reported scenario at any point in time during the investigation.The system is driving without any issues and is currently in use by the site.There are no further actions to be taken.Carestream will monitor for these types of incidents.

• Brand Name: DRX-REVOLUTION MOBILE X-RAY SYSTEM (PLUS)
• Common Device Name: DRX-REVOLUTION MOBILE X-RAY SYSTEM (PLUS)
• Manufacturer (Section D): CARESTREAM HEALTH INC.; 150 verona street; rochester 14608
• Manufacturer (Section G): CARESTREAM HEALTH INC.; 1049 ridge road west; rochester 14615
• Manufacturer Contact: alejandra benitez ; 150 verona street; rochester 14608
• MDR Report Key: 14312551
• Report Number: 1317307-2022-00004
• Device Sequence Number: 4847194
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/05/2022

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: 8118894
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/06/2022
• Initial Report FDA Received Date: 05/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2021
• 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