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

Catalog Number	8618910
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On 25-mar-2024, carestream health (csh) was informed of an incident related to the drx-revolution plus mobile x-ray system.The unit sparked when plugging the unit into the wall resulting in the tech to be shocked.The state of injury is unknown.No patient involvement.The investigation is ongoing.
Additional Manufacturer Narrative
Csh investigation is currently in progress.Submitting an initial report as there are currently insufficient facts available to make a reportability decision and at least 28 days has elapsed.Csh will submit a follow up with investigation update/findings within 30 days.
Additional Manufacturer Narrative
Carestream health inc.(csh) has investigated this issue and root cause was unable to be confirmed; however, it was determined that the most likely reason for this to occur could be copper enamel failure in the ac isolation transformer resulting from voltage surges related to geographic location or direct lightning striking the power system.Per the customer, this resulted in the tech to be shocked; however, per the investigation the described shock was unable to be confirmed.Carestream has been unable to obtain additional details regarding the status of the alleged technician's injury.The customer site was informed of the findings and csh recommended to install surge protection for the hospital system to protect all the different types of medical devices and systems in use.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 unit sparked when plugging the unit into the wall resulting in the tech to be shocked.The state of injury is unknown.No patient involvement.The investigation is ongoing.

• 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: 19180541
• Report Number: 1317307-2024-00004
• Device Sequence Number: 17962014
• Product Code: IZL
• UDI-Device Identifier: 60889978618897
• UDI-Public: (01)60889978618897
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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,Followup
• Report Date (Section B): 05/22/2024

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: 8618910
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/25/2024
• Supplement Date Received by Manufacturer: 03/25/2024
• Initial Report FDA Received Date: 04/25/2024
• Supplement Report FDA Received Date: 05/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/22/2022
• 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