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

Catalog Number	8618910
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2024, carestream health (csh) was informed of was informed of an unintended movement while using the drx-revolution plus mobile x-ray system.No injuries reported, 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 have 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 it was determined that this incident was due to a dock mechanism issue.The revolution system is designed to drive at very low speed when the tube column is undocked.In this case, the docking mechanism was incorrectly providing a signal of "undocked condition" while driving, causing the unit to come to a stop as designed.Although the unit contacted the patient, it did not result in an injury.The latch rotary assembly and the cable-mac to boom lock and column down sensor were replaced.Break-fix.The system is currently in use with no re-occurences.This type of risk is already included in the risk assessment and control matrix of the product.The risk has been mitigated as far as possible.There are no further actions to be taken by carestream health inc.Related to this issue.Carestream has completed this investigation.
Event or Problem Description
On (b)(6) 2024, carestream health (csh) was informed of was informed of an unintended movement while using the drx-revolution plus mobile x-ray system.No injuries reported.

• 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: 19381839
• Report Number: 1317307-2024-00006
• Device Sequence Number: 3769972
• Product Code: IZL
• UDI-Device Identifier: 60889978618897
• UDI-Public: (01)60889978618897
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 06/05/2024

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: 04/24/2024
• Supplement Date Received by Manufacturer: 04/24/2024
• Initial Report FDA Received Date: 05/23/2024
• Supplement Report FDA Received Date: 06/05/2024
• 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