MAUDE Adverse Event Report: CARESTREAM HEALTH INC. CARESTREAM 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	11/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 07-dec-2023, carestream health (csh) was notified by the health products regulatory authority (hpra) in (b)(6) of a user facility report ref: (b)(4).The report informed of an incident related to the drx-evolution system that occurred on (b)(6) 2023.The report outlines a radiation dose higher than expected.No injuries were reported.There have been no other reports of this type from other customers.
Additional Manufacturer Narrative
Carestream health had previously investigated this issue.The investigation determined that when the user created a new patient view with normal dose, the system reads from the previous tube warm-up view's setting and sets it to the generator, resulting in a higher exposure.A work-around has been provided to the customer until the next release of software which contains a solution to address this type of issue.Users have visibility to techniques on the user interface; it is expected that a skilled and trained radiological health care professional verifies all techniques prior to every exposure.Per radiation safety, the risk to this patient from this image 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.If the alleged issue as described by the user facility report were to re-occur, it may require a repeat image/re-exposure.A re-exposure will not lead to a serious injury.There are no further actions to be taken by carestream health related to this issue.Carestream has completed this investigation.

• Brand Name: CARESTREAM DRX-EVOLUTION SYSTEM
• Common Device Name: CARESTREAM 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: 18449444
• Report Number: 1317307-2023-00014
• Device Sequence Number: 12495384
• Product Code: KPR
• UDI-Device Identifier: 60889971739193
• UDI-Public: 0160889971739193
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• 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): 01/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 12/07/2023
• Initial Report FDA Received Date: 01/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2023
• 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