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

Catalog Number	8118894
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Head Injury (1879)
Date of Event	03/11/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Carestream health has evaluated the device and determined that the system was operational and functioning as designed and intended.This was a user error due to not docking the tube head while transporting the drx-revolution plus system in an elevator while in motion.This resulted in the column to dropdown (undocked tube head) due to gravity force when the elevator is moving downward.There was no patient involvement.Per the instructions for use (ifu) for the drx-revolution plus systems, it states a warning, "retract the boom and place in a docked position anytime the cart is driven".The site tech (user) was not driving the system as specified in the ifu.It is unlikely, if following the driving recommendations provided within the ifu, that this type of injury would occur.
Event or Problem Description
On 16-mar-2022, carestream health (csh) was informed of an incident related to the drx-revolution plus mobile x-ray system which occurred at (b)(6) hospital - (b)(6).The site radiographer alleged that on (b)(6) 2022, while transporting the drx revolution plus system through in an elevator, the radiographer was hit on the head by the tube head of the system.This resulted in a head injury which required hospitalization.There was no patient involvement.

• Brand Name: DRX-REVOLUTION PLUS MOBILE X-RAY SYSTEM
• Common Device Name: DRX-REVOLUTION PLUS MOBILE X-RAY SYSTEM
• 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: 13973540
• Report Number: 1317307-2022-00003
• Device Sequence Number: 4776835
• Product Code: IZL
• UDI-Device Identifier: 60889978618897
• UDI-Public: 0160889978618897
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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): 03/31/2022

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 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: 03/16/2022
• Initial Report FDA Received Date: 04/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2013
• 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