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

Catalog Number	1019397
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	08/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Carestream health has evaluated the device and determined there was no device malfunction, the system is performing as designed and intended.There was no patient involvement.The incident was caused by the site tech (user) not following the instructions for use (ifu).The reporter stated that the tech was holding a door with one hand and driving the system with the other hand when the incident occurred as opposed to using both hands to drive the revolution as specified in the ifu.It is unlikely, if following the driving recommendations provided within the ifu, that this type of injury would occur.The site has started using rubber stoppers to assist with keeping doors open in order to avoid this type of incident.Carestream health has concluded this investigation.
Event or Problem Description
The customer site alleged that the tech/operator was trying to hold a door open with one hand and drive the cart with the other hand (1 hand).As a result, the tech drove the drx revolution over her foot resulting in broken toe injury.

• Brand Name: DRX REVOLUTION PLUS MOBILE X-RAY SYSTEM
• Common Device Name: DRX REVOLUTION PLUS MOBILE X-RAY SYSTEM
• MDR Report Key: 12411699
• Report Number: 1317307-2021-00005
• Device Sequence Number: 3308830
• Product Code: IZL
• UDI-Device Identifier: 60889978618897
• UDI-Public: 0160889978618897
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/01/2021

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 Catalogue Number: 1019397
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/26/2021
• Initial Report FDA Received Date: 09/01/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2021
• 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