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

Catalog Number 1019397

Device Problem Unintended Movement (3026)

Patient Problem Hematoma (1884)

Event Date 11/17/2023

Event Type  Injury  

Manufacturer Narrative

Carestream health has evaluated the device.The investigation determined that the right side load cell failure was due to previous impact(s) or impact(s) with enough force (e.G., user accidentally collides with a wall or other obstruction) to affect the load cell, the cart drive calibration, and the cart driving.This was evidenced by the damaged right side panel and inner handle covers.As a result, the tech obtained a bruise on the leg and arm.It could not be confirmed by the site if medical attention was required.There was no patient involvement.The field engineer replaced the right load cell and successfully performed a cart drive calibration.The cart drive was tested and is now working properly.There are no further actions to be taken by carestream health related to this issue.Carestream has completed this investigation.

Event Description

On 18-nov-2023, carestream health (csh) was informed of an incident related to the drx-revolution mobile x-ray system.The technologist was behind the portable in the hallway outside the patient's room, she tried to drive forward using both hands on the drive handle; however, the unit drove backwards pinning her between the wall and the portable.

• 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: 18310300
• MDR Text Key: 330279242
• Report Number: 1317307-2023-00011
• Device Sequence Number: 1
• Product Code: IZL
• UDI-Device Identifier: 60889971019394
• UDI-Public: 0160889971019394
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 12/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 1019397
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2018
• 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