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

Catalog Number	8618894
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Carestream health inc.(csh) has investigated this issue and it was determined that this was due to user error while driving the unit by putting the tech's back against a door while pulling the device towards him and through the door.This resulted in the tech's leg to be injured.Carestream has been unable to obtain additional details regarding the status of the technician's injury.The customer site was informed of the findings and csh reiterated to follow the instructions for use and recommended guidelines for driving the system.The drx-revolution system was evaluated, and it was confirmed that it was functioning as designed and intended.There are no further actions to be taken by carestream health inc.Related to this issue.The risk has been mitigated as far as possible.Carestream has completed this investigation.
Event or Problem Description
On 20-feb-2024, carestream health inc.(csh) was informed of an unintended movement while using the drx-revolution plus mobile x-ray system.

• Brand Name: DRX REVOLUTION MOBILE X-RAY SYSTEM
• Common Device Name: 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: 18909658
• Report Number: 1317307-2024-00003
• Device Sequence Number: 6886466
• Product Code: IZL
• UDI-Device Identifier: 60889978618897
• UDI-Public: 0160889978618897
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/14/2024

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: 8618894
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/20/2024
• Initial Report FDA Received Date: 03/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2020
• 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