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

Model Number	DRX-Revolution Mobile X-ray System
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/19/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Carestream health has evaluated the device.Csh service engineering investigation: fe confirmed that the spark was observed by the employee while inserting the power plug.Found no physical design defects on the returned cord reel/plug.No issues were observed during energized resistance testing - this confirms no shorts and no concerns with the returned condition of the power plug.The fe confirmed the spark observed by the employee while inserting the power plug.The sparking could be attributable to known cause of unplugging or plugging the power plug while the ac breaker on.Cord reel replaced and soft start circuit to mitigate sparking has been installed.Break-fix.The drx-revolution mobile x-ray systems are tested and conform to all the required iec 60601-1 medical electrical equipment safety standards applicable to this product.When the plug is properly inserted or removed from the receptacle, the presence of small blue arcs does not pose a hazard to the user.This component does not generate electricity and cannot cause the operator to receive a shock.It remains unknown how the operator could have received a shock because the plug is an insulated housing made of plastic non-conductive material.Carestream has completed this investigation.
Event or Problem Description
On (b)(6) 2022, carestream health (csh) was informed, of an incident which occurred at kaiser mt.View.The site alleged that while plugging in the drx-revolution system, a tech observed a spark and then felt electricity through their hand.The tech visited the emergency room due to experiencing heart palpitations after the incident.There have been no additional details regarding the tech's status or condition.There was no patient involvement.

• Brand Name: DRX-REVOLUTION MOBILE X-RAY SYSTEM (PLUS)
• Common Device Name: DRX-REVOLUTION MOBILE X-RAY SYSTEM (PLUS)
• 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: 14779447
• Report Number: 1317307-2022-00009
• Device Sequence Number: 17626216
• Product Code: IZL
• UDI-Device Identifier: 60889978618897
• UDI-Public: (01)60889978618897
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/21/2022

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 Model Number: DRX-Revolution Mobile X-ray System
• Device Catalogue Number: 8118894
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/23/2022
• Initial Report FDA Received Date: 06/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2022
• 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