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

Catalog Number	8118894
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	10/03/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Carestream health has evaluated the device.The investigation found that there were no device malfunctions and the incident was caused by the user not following the instructions for use (ifu).The site contact confirmed that the tech was not positioned directly behind the unit to drive the revolution as specified in the ifu.There was no device malfunction.This was due to user error.The service personnel communicated to the operators to be positioned directly behind the unit, per the instructions for use (ifu), while driving the system.Carestream has completed this investigation.
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 (b)(6), brazil on (b)(6) 2022.Per carestream health service personnel investigation which confirmed the following: the system in "as found" condition: found no abnormality in the driving cart.At the time of the incident, the system was being driven by a site tech.The technologist was reversing the system out of an elevator when the drx-revolution passed over the operator's toe.The incident resulted in a toe injury where the tech's toe was fractured.There was no patient involvement.

• Brand Name: DRX-REVOLUTION MOBILE X-RAY SYST
• Common Device Name: DRX-REVOLUTION MOBILE X-RAY SYST
• 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 14608 ; 5856278533
• MDR Report Key: 15708210
• Report Number: 1317307-2022-00011
• Device Sequence Number: 20460277
• Product Code: IZL
• UDI-Device Identifier: 60889971019394
• UDI-Public: 0160889971019394
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/28/2022

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: 10/03/2022
• Initial Report FDA Received Date: 11/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2016
• 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