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

Catalog Number	1030725
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2023
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 and at least 29 days has elapsed.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 by dealer fe that a customer site reported a thermal incident related to the drx revolution system.No injuries reported.The investigation is ongoing.
Event or Problem Description
On 21-mar-2023, carestream health inc.Was informed by dealer fe 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 and at least 29 days has elapsed.Csh will submit a follow up with investigation update/findings within 30 days.Follow up #1 (final) carestream health inc (csh) has received and evaluated the drx revolution system.No patient injury occurred.The issue is confirmed to be a thermal event linked to a communication & power industries inc.(cpi - manufacturer) generator issue, where the +120 vdc high voltage (hv) cable insulation was punctured by a pin from a component on the circuit board resulting in a high energy short circuit due to vibration over time.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 will provide a service exchange of the system.Csh has concluded this investigation.

• 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: nancy mejias ; 150 verona street; rochester, NY 14608 ; 5856278533
• MDR Report Key: 16777101
• Report Number: 1317307-2023-00005
• Device Sequence Number: 6849454
• Product Code: IZL
• UDI-Device Identifier: 60889971019394
• UDI-Public: 0160889971019394
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: 505
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2023

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: 1030725
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/21/2023
• Supplement Date Received by Manufacturer: 03/21/2023
• Initial Report FDA Received Date: 04/20/2023
• Supplement Report FDA Received Date: 05/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2017
• 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