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

Catalog Number	8618894
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	09/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer site alleged that while in a hurry, the operator was trying to hold a door open with one hand and drive the cart with the other hand (1 hand), all whilst standing beside the machine.As a result, the tech drove the drx revolution over her own toes (no patient involvement), resulting in broken toes.Carestream health has evaluated the device.The investigation found that there were no device malfunctions and the incident was caused by the user 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.The site biomed confirmed that the tech did not use both hands to drive the revolution as specified in the ifu.Carestream health representatives 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 customer site alleged that while in a hurry, the operator was trying to hold a door open with one hand and drive the cart with the other hand (1 hand), all whilst standing beside the machine.As a result, the tech drove the drx revolution over her toes, resulting in broken toes.

• Brand Name: DRX-REVOLUTION MOBILE X-RAY SYSTEM
• Common Device Name: DRX-REVOLUTION MOBILE X-RAY SYSTEM
• Manufacturer (Section D): CARESTREAM HEALTH INC.; 150 verona street; rochester NY 14608
• MDR Report Key: 10709498
• Report Number: 1317307-2020-00005
• Device Sequence Number: 3933183
• Product Code: IZL
• UDI-Device Identifier: 60889978618897
• UDI-Public: 0160889978618897
• Combination Product (Y/N): Y
• 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: health professional,user faci
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 10/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 8618894
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/29/2020
• Initial Report FDA Received Date: 10/21/2020
• 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