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

Catalog Number 1019397

Device Problem Unintended System Motion (1430)

Patient Problem Laceration(s) (1946)

Event Date 09/22/2021

Event Type  Injury  

Manufacturer Narrative

Carestream health has evaluated the device and determined that the right and left strain gauges were out of balance.The left and right strain gauges independently control the speed of acceleration of each of the drive wheels.Pushing harder on the drive handle on one side deflects the flexure on that side.The strain gauge measures the deflection and accelerates the drive wheel on that side faster.The strain gauges were recalibrated and re-tested resulting in normal operation.Both strain gauges were replaced as a precautionary measure.There was no patient involvement.In addition, the site tech (user) was not driving the system as specified in the ifu, with both hands on the drive handle.It is unlikely, if following the driving recommendations provided within the ifu, that this type of injury would occur.For udi field d4, there is no udi noted.The drx revolution system was manufactured in february 2013 prior to udi requirement; therefore, no udi is provided.

Event Description

On (b)(6) 2021, carestream health (csh) was informed of an incident related to the drx-revolution mobile x-ray system which occurred at (b)(6) hospital - usa.The site lead tech, christina, alleged that on (b)(6) 2021, while driving the drx revolution system through a metal doorway, a tech pinched her finger in the doorway.This resulted in a cut on her pinky finger which required stitches.There was no patient involvement.

• Brand Name: DRX-REVOLUTION MOBILE X-RAY SYSTEM
• Type of Device: DRX-REVOLUTION MOBILE X-RAY SYSTEM
• Manufacturer (Section D): CARESTREAM HEALTH; 150 verona street; rochester NY 14608
• MDR Report Key: 12666718
• MDR Text Key: 277723906
• Report Number: 1317307-2021-00007
• Device Sequence Number: 1
• Product Code: IZL
• Combination Product (y/n): N
• PMA/PMN Number: K191025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 10/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 1019397
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/23/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other