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

Catalog Number 8618894

Device Problem Unintended Movement (3026)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/18/2023

Event Type  Injury  

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 by placing a clipboard in the middle of the drive handle of the unit.The incident was caused by the user not following the instructions for use (ifu).It was confirmed that the weight of the clipboard closed the deadman switches in the drive handle and had enough weight to unbalance the drive mechanism.The service personnel communicated to the operators to not insert anything in the space between the handle and the cart, while using the system.The site will also proactively install a bin divider as a precautory measure so that a clipboard cannot be placed in that holder anymore.There are no further actions to be taken by carestream health related to this issue.Carestream has completed this investigation.

Event Description

On (b)(6) 2023, carestream health (csh) was informed of an incident related to the drx-revolution plus mobile x-ray system.The technologist was on route to a patient's room and parked the unit.However, after letting go of the unit, it drove backwards into the wall.No injuries were reported.

• 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: 17919720
• MDR Text Key: 325487541
• Report Number: 1317307-2023-00010
• Device Sequence Number: 1
• Product Code: IZL
• UDI-Device Identifier: 60889978618897
• UDI-Public: (01)60889978618897
• 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: 10/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2023
• 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: 09/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other