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

Catalog Number	1019397
Health Effect - Clinical Codes	Chemical Exposure (2570); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Root cause cannot be determined at this time.Csh is waiting for the site to release the drx revolution system so the dealer can ship it to csh in the u.S.For analysis/investigation.Csh will submit a follow up report within the required timeframe.
Event or Problem Description
On (b)(6) 2021, carestream health (csh) was informed of an incident related to the drx-revolution mobile x-ray system which occurred at (b)(6) hospital - (b)(6).The dealer alleged a thermal event occurred with the drx revolution system.Three individuals within the vicinity of the system were treated for smoke inhalation and released the same day with no additional treatment required.
Additional Manufacturer Narrative
Root cause cannot be determined at this time.Csh is waiting for the site to release the drx revolution system so the dealer can ship it to csh in the u.S.For analysis/investigation.Csh will submit a follow up report within the required timeframe.Follow up #1 - update: the system has been shipped by the korea dealer and has arrived at carestream health for forensic evaluation the week of 08-nov-2021.Carestream health inc.Will provide a 2nd follow up report upon completion of the investigation.
Event or Problem Description
On 18-sep-2021, carestream health (csh) was informed of an incident related to the drx-revolution mobile x-ray system which occurred at (b)(6) hospital - korea.The dealer alleged a thermal event occurred with the drx revolution system.Three individuals within the vicinity of the system were treated for smoke inhalation and released the same day with no additional treatment required.
Event or Problem Description
On 18-sep-2021, carestream health (csh) was informed of an incident related to the drx-revolution mobile x-ray system which occurred at ewha womens university hospital - korea.The channel partner alleged a thermal event occurred with the drx revolution system.Three individuals within the vicinity of the system were treated for smoke inhalation and released the same day with no additional treatment required.Per the channel partner, there was no patient involvement.
Additional Manufacturer Narrative
Root cause cannot be determined at this time.Csh is waiting for the site to release the drx revolution system so the dealer can ship it to csh in the u.S.For analysis/investigation.Csh will submit a follow up report within the required timeframe.Follow up #1 - update: the system has been shipped by the korea dealer and has arrived at carestream health for forensic evaluation the week of 08-nov-2021.Carestream health inc.Will provide a 2nd follow up report upon completion of the investigation.Follow up #2 (final report): carestream health inc (csh) has received and evaluated the drx revolution system.There was evidence of heat and smoke but no visible evidence of flame.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 most likely punctured by a pin from capacitor c51 resulting in a high energy short circuit.The cpi generator (serial # - (b)(6)) installed for this revolution system (serial # (b)(6)) was manufactured december 2016, prior to the implementation of cpi's corrective actions initiated in feb-2017.Cpi began to ship generators to carestream with hv cables insulated with fiberglass to prevent punctures.No thermal events of this nature have been reported to carestream for revolution systems with cpi generators manufactured after feb-2017 thus indicating the corrective actions implemented by cpi were effective.The thermal event is not considered a safety risk as this failure 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.The excessive heat generated by the internal thermal event was enough to damage/melt the lower portion of the storage cup holder on the upper rear area of the unit which is still considered to be self-contained within the unit itself.Csh will provide a service exchange of the system.Based on the findings, there will be no additional actions taken.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; 150 verona st; rochester NY 14608
• Manufacturer (Section G): CARESTREAM HEALTH; 1049 ridge road west; rochester NY 14615
• Manufacturer Contact: nancy mejias ; 150 verona street; rochester 14608 ; 5856278533
• MDR Report Key: 12631162
• Report Number: 1317307-2021-00006
• Device Sequence Number: 4212174
• Product Code: IZL
• UDI-Device Identifier: 60889971019394
• UDI-Public: 0160889971019394
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Other,Foreign
• Initial Reporter Occupation: 505
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/02/2021

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?: Yes
• Device Catalogue Number: 1019397
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2021
• Supplement Date Received by Manufacturer: 09/18/2021; 09/18/2021
• Initial Report FDA Received Date: 10/14/2021
• Supplement Report FDA Received Date: 11/11/2021; 12/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2016
• 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