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

Catalog Number	8618894
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2023
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 14-nov-2023, carestream health inc.Was informed of an incident where smoke was coming out of the drx-revolution system.No injuries reported, the investigation is ongoing.
Additional Manufacturer Narrative
Carestream health inc.(csh) has investigated this issue and conclusive root cause could not be determined because investigation logs could not be obtained from the impacted system.From the limited information available, the investigation team determined that connectors on the charger monitor board (cmb) were not fully seated and latched that led to arcing between contacts.This may produce excessive heat leading to the thermal incident observed.Carestream has repaired the customer's system and initiated a corrective action to review and update applicable servicing and manufacturing procedures to ensure connectors are fully seated.Per the product safety & performance risk assessment, carestream's investigation team determined that the overall product safety risk is low.The risk has been mitigated as far as possible.There are no further corrective or preventive actions to be taken by carestream health inc.Related to this issue.Carestream has completed this investigation.
Event or Problem Description
On 14-nov-2023, carestream health inc.Was informed of a thermal incident related to the drx-revolution system.No injuries reported.
Additional Manufacturer Narrative
On december 13, 2023 an initial report was submitted as there were insufficient facts available to make a reportability decision.Submitting a follow up #1 as investigation is ongoing.Csh will submit a follow up with investigation update/findings within 30 days.
Event or Problem Description
On 14-nov-2023, carestream health inc.Was informed of an incident where smoke was coming out of the drx-revolution system.No injuries reported, the investigation is ongoing.
Additional Manufacturer Narrative
On december 13, 2023 an initial report was submitted as there were insufficient facts available to make a reportability decision.Submitting a follow up #2 as investigation is ongoing.Csh will submit a follow up with investigation update/findings within 30 days.
Event or Problem Description
On 14-nov-2023, carestream health inc.Was informed of an incident where smoke was coming out of the drx-revolution system.No injuries reported, the investigation is ongoing.

• 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: 18383235
• Report Number: 1317307-2023-00012
• Device Sequence Number: 18094225
• Product Code: IZL
• UDI-Device Identifier: 60889978618897
• UDI-Public: 0160889978618897
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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,Followup,Followup
• Report Date (Section B): 03/06/2024

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: 8618894
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/14/2023
• Supplement Date Received by Manufacturer: 11/14/2023; 11/14/2023; 11/14/2023
• Initial Report FDA Received Date: 12/22/2023
• Supplement Report FDA Received Date: 01/09/2024; 02/08/2024; 03/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2022
• 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