MAUDE Adverse Event Report: CARESTREAM HEALTH DRX EVOLUTION SYSTEM

Device Problem Device Fell (4014)

Patient Problem Injury (2348)

Event Date 05/17/2020

Event Type  Injury  

Manufacturer Narrative

Per the investigation, it has been confirmed that the full featured wallstand latch on the drx evolution system was working as intended.The tech thought that the grid was latched and rotated it 90 degrees for the exam.The grid fell out of the bucky causing the patient injury.Typically when the grid is inserted into the bucky an audible "click" is heard by the tech.This "click" indicates the grid is properly latched and the bucky can be rotated 90 degrees.In this instance, evidence shows that the grid was believed to be latched already based on the visual appearance of the grid in the bucky so an audible "click" was not heard.The drx evolution's console and system monitor also has a visual indicator which provides confirmation of grid presence in the bucky.This visual indicator can be used as a secondary verification to ensure the grid is properly inserted.In this instance, neither the primary indicator (click) nor the secondary (console/monitor indicators) were used to verify the proper latching of the grid before rotating 90 degrees.Carestream has concluded this investigation and therefore a follow up is not required.Since this device (s/n (b)(4)) was manufactured prior to udi requirements only a s/n is recorded.

Event Description

The site reported that the grid fell out of the bucky unit while imaging a patient.The grid fell out after the tech rotated the bucky 90 degrees in vertical position and landed on a patient's foot resulting in a broken toe which required medical intervention.Drx-evolution system w/full feature (ff) wall stand evolution system (k # 46120983 / serial # (b)(4)).

• Brand Name: DRX EVOLUTION SYSTEM
• Type of Device: DRX EVOLUTION SYSTEM
• Manufacturer (Section D): CARESTREAM HEALTH; 150 verona st; rochester, ny
• Manufacturer (Section G): CARESTREAM HEALTH; 1049 ridge rd west; rochester, ny
• Manufacturer Contact: nancy meijas ; 150 verona st; rochester, ny ; 6278533
• MDR Report Key: 10155570
• MDR Text Key: 196262900
• Report Number: 1317307-2020-00002
• Device Sequence Number: 1
• Product Code: KPR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other