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

Catalog Number	8118894
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/23/2022
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 reported confirmed that the tech did not use both hands, one hand holding open a door, 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 use both hands, per the instructions for use (ifu), while driving the system.The site has also started using rubber door stops to hold open doors when driving the drx revolution through doorways to mitigate these types of incidents.Carestream has completed this investigation.
Event or Problem Description
On (b)(6) 2022, carestream health (csh) was informed, via email, of an incident related to the drx-revolution plus mobile xray system which occurred at dr (b)(6) on (b)(6) 2022.Per carestream health service personnel investigation which confirmed the following: the system in "as found" condition: normal working conditions with no issues.At the time of the incident, the system was being driven by a site tech.Per the report, the tech/operator was holding a door open with one hand and attempting to drive the drx revolution plus system with the other hand when backing into the intensive care unit and drove the system over her foot.The tech was able to drive the system forward off of her foot.The incident resulted in a toe injury where the tech lost the toe nail.There was no patient involvement.

• 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 NY 14608
• Manufacturer (Section G): CARESTREAM HEALTH INC.; 1049 ridge road west; rochester NY 14615
• Manufacturer Contact: nancy mejias ; 150 verona street; rochester, NY 14608 ; 5856278533
• MDR Report Key: 14501337
• Report Number: 1317307-2022-00007
• Device Sequence Number: 14847476
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/24/2022

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/03/2022
• Initial Report FDA Received Date: 05/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2021
• 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