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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARESTREAM HEALTH DRX EVOLUTION SYSTEM

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CARESTREAM HEALTH DRX EVOLUTION SYSTEM Back to Search Results
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)).
 
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Brand NameDRX EVOLUTION SYSTEM
Type of DeviceDRX 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 Key10155570
MDR Text Key196262900
Report Number1317307-2020-00002
Device Sequence Number1
Product Code KPR
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K141837
Number of Events Reported1
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 Received06/15/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/17/2020
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

Patient Treatment Data
Date Received: 06/15/2020 Patient Sequence Number: 1
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