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

Catalog Number	1019397
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Carestream health has evaluated the device and determined there was no device malfunction and the system is performing as designed and intended.The investigation found that there were no device malfunctions and the incident was caused by the student tech not following the instructions for use (ifu).Per the ifu, the operator must use both hands and drive behind the drx revolution in order to prevent injury.Per the site, the operator had informal training on the drx revolution system; however, csh cannot determine the extent or suitability of the training provided.Improper handling of the drive handle has been attributed to the unintended rearward motion of the cart.Users of the drx-revolution should grasp the drive handle only.When grasping the free-floating handle and the stationary side cover at the same time, the user's hands do not move with the drive handle as intended.Therefore, the forward motion is immediately followed by rearward motion, as the users' hands stay "with" the side covers which are moving forward.Carestream health representative reiterated to the site the importance of following the driving instructions provided within the instructions for use.There are no further actions to be taken by carestream health related to this issue.
Event or Problem Description
The site biomed reported that a student tech was maneuvering the drx revolution system between two beds in a patient's room.The student began to move the system out from between the two beds and started to turn the unit towards the entrance/exit door to the room when the system moved backwards toward her.According to the report, the drx revolution contacted the student tech's groin area.There was no discoloration of the area, but the student experiences, and still experiences pain when she touches the area.The tech noted a lump in the area; however, there were no broken bones or fractures.The tech was examined in the emergency department after the incident but has not needed further care since this time.There was no patient involvement.

• Brand Name: DRX REVOLUTION MOBILE X-RAY SYSTEM
• Common Device Name: DRX REVOLUTION
• Manufacturer (Section D): CARESTREAM HEALTH; 150 verona st; rochester NY 14608
• MDR Report Key: 11654288
• Report Number: 1317307-2021-00002
• Device Sequence Number: 14308565
• Product Code: IZL
• UDI-Device Identifier: 60889971019394
• UDI-Public: 0160889971019394
• Combination Product (Y/N): N
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 04/12/2021

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?: No
• Operator of Device: Other
• Device Catalogue Number: 1019397
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/16/2021
• Initial Report FDA Received Date: 04/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other