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

Catalog Number 8618894

Device Problem Unintended Movement (3026)

Patient Problem Pain (1994)

Event Date 05/05/2023

Event Type  Injury  

Event Description

On (b)(6) 2023, carestream health inc.Was informed about incident while driving the drx revolution system.The technologist was on route to do an exam when she reached to hold the automatic door open with one hand and backed up the mobile with the other hand.As the technologist was reversing the mobile, it quickly accelerated and pinned her against the wall.As a result, the tech experienced pain in her right hip and she was limping.She had ice on her hip and was directed to go visit a doctor for a follow up visit.She was sent home for the day.There was no patient involvement.

Manufacturer Narrative

Carestream health has evaluated the device and determined there was no device malfunction, and the drx revolution system is performing as designed and intended.It was confirmed that this incident was due to user error while driving the system with one hand positioned at the edge of the drive handle compressing the side covers; at the same time, the other hand was used to hold open.The incident was caused by the user not following the instructions for use (ifu).The site contact confirmed that the tech did not use both hands while driving the drx revolution system.The service personnel communicated to the operators to use both hands, per the instructions for use (ifu), while driving the system.The site will also re-enforce techs training to not push drive handle on edge compressing the side covers.Carestream has completed this investigation.

• Brand Name: DRX REVOLUTION MOBILE X-RAY SYSTEM
• Type of Device: DRX REVOLUTION MOBILE X-RAY SYSTEM
• 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, NY 14608 ; 5856278533
• MDR Report Key: 17008043
• MDR Text Key: 315990758
• Report Number: 1317307-2023-00006
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8618894
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2020
• 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