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

Model Number	DRX-REVOLUTION MOBILE X-RAY SYSTEM
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer site reported that while operating the drx-revolution mobile x-ray system, a site tech backed up over her foot/ankle requiring medical attention on (b)(6) 2021.There was no patient involvement.Carestream health has evaluated the device and determined there was no device malfunction, the system is performing as designed and intended.The incident was caused by the user not following the instructions for use (ifu).The reporter details noted that the tech was most likely driving the system with one hand when the incident occurred as opposed to using both hands to drive the revolution as specified in the ifu.The site declined to provide additional details related to this incident.It is unlikely, if following the driving recommendations provided within the ifu, that this type of injury would occur.Carestream health has concluded this investigation.
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.Initially the site biomed, (b)(6), called in with a request to slow down the backup speed of the drx revolution system.When informed that the speed cannot be changed, (b)(6) called carestream health (csh) and reported an injury.Specifically, (b)(6) (last name not provided due to privacy) - a trained site tech, backed the machine over her foot/ankle while driving the system with one hand.She is currently out of work due to injury.The biomed stated that there were no malfunctions with the drx revolution at the time of the incident.Csh field service has attempted to confirm and obtain details related to the incident, however, the site will not provide additional information.

• Brand Name: DRX-REVOLUTION MOBILE X-RAY SYSTEM
• Common Device Name: DRX-REVOLUTION MOBILE X-RAY SYSTEM
• MDR Report Key: 12310843
• Report Number: 1317307-2021-00003
• Device Sequence Number: 5002394
• Product Code: IZL
• UDI-Device Identifier: 60889971019394
• UDI-Public: 0160889971019394
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/11/2021

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: Health Professional
• Device Model Number: DRX-REVOLUTION MOBILE X-RAY SYSTEM
• Device Catalogue Number: 1019397
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/20/2021
• Initial Report FDA Received Date: 08/11/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2018
• 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