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

Catalog Number 8118894

Device Problem Unintended Movement (3026)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/23/2022

Event Type  Injury  

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 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)
• Type of Device: 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
• MDR Text Key: 293181304
• Report Number: 1317307-2022-00007
• Device Sequence Number: 1
• Product Code: IZL
• UDI-Device Identifier: 60889978618897
• UDI-Public: 0160889978618897
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K191025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8118894
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other