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

Catalog Number	8624181
Medical Device Problem Code	Loss of Data (2903)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Carestream health (csh) has investigated this issue.The investigation determined that this is a hardware issue (dap cable stability issue).The logs indicated a loose/unstable connection of the dap unit.When this occurs (dap cable disconnected), imageview software cannot recover the dap value even after the link is restored.As a result, the dap that is physically shooted is missing from the images.It was confirmed that: the right techniques were shooted and available to the user (kvp, mas, ma and ms data), this does not affect the quality of the image as the right dap is being shooted, there were no over-exposures/re-exposures as the right dap is being shooted, the system is currently in use and the system has been monitored and there have been no re-occurrences.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.If the issue 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.
Event or Problem Description
On 15-dec-2025, carestream health (csh) was informed of an incident related to the drx-compass system that occurred on 28-nov-2025.No injuries were reported.

• Brand Name: DRX-COMPASS SYSTEM
• Common Device Name: DRX-COMPASS SYSTEM
• Manufacturer (Section D): CARESTREAM HEALTH INC.; 150 verona street; rochester NY 14608
• Manufacturer (Section G): RAYCO (SHANGHAI) MEDICAL PRODUCTS COMPANY LIMITED; building7 no 1510 chuanqiao rd; china pilot free trade zone; shanghai 20120 6; CH 201206
• Manufacturer Contact: alejandra benitez ; 150 verona street; rochester, NY 14608 ; 5856278533
• MDR Report Key: 23866154
• Report Number: 3004105475-2025-00005
• Device Sequence Number: 5343827
• Product Code: KPR
• UDI-Device Identifier: 60889978624188
• UDI-Public: 0160889978624188
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K201373
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/22/2025

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: 8624181
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2024
• 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