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

Catalog Number	8618894
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	04/13/2024
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 bad outlet and the use of a non-approved plug.The customer had used an aftermarket plug tip on the cord reel as this customer is serviced by a third party (biomed).Biomed did not follow the caution warnings or guidance from the preventative maintenance manual and hardware guide which provides information on carestream approved parts replacement processes and parts.The customer site was informed of the findings and csh reiterated to follow the guidelines and list of approved parts.This incident resulted in the tech's thumb to be injured (burn).Carestream has been unable to obtain additional details regarding the status of the technician's injury.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 (b)(6) 2024, carestream health (csh) was informed of an incident related to the drx-revolution plus mobile x-ray system.The plug on the power cord was smoking when unplugging the unit from an electrical wall outlet resulting in the tech to burn her thumb.No patient involvement.

• 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: 19295803
• Report Number: 1317307-2024-00005
• Device Sequence Number: 7142839
• Product Code: IZL
• UDI-Device Identifier: 60889978618897
• UDI-Public: (01)60889978618897
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): Y
• 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): 05/08/2024

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: 04/13/2024
• Initial Report FDA Received Date: 05/12/2024
• 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