MAUDE Adverse Event Report: CARESTREAM HEALTH INC. DRX-EVOLUTION SYSTEM

Catalog Number	1002237
Medical Device Problem Code	Radiation Overexposure (3017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On (b)(6) 2023, the business partner (bp) medray, informed carestream health that a site exposed a patient more than 10x the expected dose.Per the investigation, it was determined that the user added a wrong view to a chest exam by mistake causing the overexposure.Root cause: the operator had added a hip view to a chest exam, due to this, the location defaulted to wall stand with detector instead of table with detector.This resulted in large mas and the operator did not verify the exposure parameters when reviewing the proper workspace selection.The operator had enough time to check the techniques on the screen.They didn't check techniques before exposing.The business parter applications went on site and explained to the customer the correct techniques to be used.The fe reiterated that the tech should verify all techniques before exposing.Per our radiation safety representative, and based on the techniques used for the exposure, the risk to this pediatric patient is minimal.The additional radiation dose is well below that which would result in any prompt effects like skin erythema, and the additional risk from stochastic effects is negligible.The system is currently in use.This was a one time event.There have been no re-occurrences.Csh has concluded this investigation.
Event or Problem Description
On (b)(6) 2023, the business partner (bp) medray, informed carestream health that a site exposed a patient more than 10x the expected dose.Expected dose: 100 kv, 28mas.Given dose: 100 kv, 353.2mas.

• Brand Name: DRX-EVOLUTION SYSTEM
• Common Device Name: DRX-EVOLUTION 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: 17736223
• Report Number: 1317307-2023-00007
• Device Sequence Number: 15172691
• Product Code: KPR
• UDI-Device Identifier: 60889971739193
• UDI-Public: 0160889971739193
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K091889
• 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): 09/12/2023

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: 1002237
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/15/2023
• Initial Report FDA Received Date: 09/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2022
• 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