MAUDE Adverse Event Report: CARESTREAM HEALTH INC. DRX-REVOLUTION MOBILE X-RAY SYSTEM; MOBILE 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	09/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer site alleged that while a tech was driving the drx revolution system out of an elevator on (b)(6) 2020, the system jerked backwards onto the tech's foot resulting in broken toes injury.There was no patient involvement.Carestream health has evaluated the device and determined there was no device malfunction and the system is performing as designed and intended.Although the site alleged that the tech(s) was driving the drx revolution system as recommended per the instructions for use (ifu) provided by the manufacturer (csh), it is unclear how the injury would have occurred if the tech(s) was following the ifu for the system.It is unlikely, if following the driving recommendations provided within the ifu, that this type of injury would occur.The injury is most likely due to user error not following the recommended guidelines for driving the drx revolution system.
Event or Problem Description
The site alleged that whilst driving the drx revolution out of an elevator on (b)(6) 2020, the system jerked backwards onto the tech's foot resulting in a broken toe injury.The tech was out of work due to injury.

• Brand Name: DRX-REVOLUTION MOBILE X-RAY SYSTEM
• Common Device Name: MOBILE SYSTEM
• Manufacturer (Section D): CARESTREAM HEALTH INC.; 150 verona street; rochester NY 14608
• MDR Report Key: 10744849
• Report Number: 1317307-2020-00008
• Device Sequence Number: 16560923
• Product Code: IZL
• UDI-Device Identifier: 60889971019394
• UDI-Public: 0160889971019394
• Combination Product (Y/N): Y
• Initial Reporter State: NH
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/26/2020

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: 10/27/2020
• 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