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

Catalog Number	1019397
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2023
Type of Reportable Event	Malfunction
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.Csh will submit a follow up with investigation update/findings within 30 days.
Event or Problem Description
On (b)(6) 2023, carestream health inc.Was informed that a customer site reported a thermal incident related to the drx revolution 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.Csh will submit a follow up with investigation update/findings within 30 days.Follow up #1 (final).Carestream health inc (csh) has evaluated the drx revolution system.No patient injury occurred.The issue is confirmed to be a component failure, the support bracket on the left of the inverter board got broken and it is suspected that it touched the positive pole connector on the inverter board resulting in a short circuit routing the 240vdc to the frame ground.The thermal event is not considered a safety risk as this thermal event occurred within the sheet metal enclosure of the generator unit making the thermal event self-contained within the system and did not breach the outer walls (four sides) of the revolution system.Csh replaced and installed a new generator.Csh has concluded this investigation.
Event or Problem Description
On 27-sep-2023, carestream health inc.Was informed that a customer site reported a thermal incident related to the drx revolution 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: 17928156
• Report Number: 1317307-2023-00009
• Device Sequence Number: 12411022
• Product Code: IZL
• UDI-Device Identifier: 60889971019394
• UDI-Public: (01)60889971019394
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K191025
• 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,Followup
• Report Date (Section B): 10/25/2023

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: 1019397
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/27/2023
• Supplement Date Received by Manufacturer: 09/27/2023
• Initial Report FDA Received Date: 10/12/2023
• Supplement Report FDA Received Date: 10/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2019
• 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