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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARESTREAM HEALTH INC. DRX EVOLUTION SYSTEM

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CARESTREAM HEALTH INC. DRX EVOLUTION SYSTEM Back to Search Results
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Injury (2348)
Event Date 07/22/2020
Event Type  Injury  
Manufacturer Narrative
Per the investigation, it has been confirmed that the drx evolution system was working as intended. A carestream fe checked and verified the overhead tube crane (otc) was functional: the motor assist feature, which assists operator to drive the otc in a given direction was off and there were no detents programmed in (allows for smooth operation/movement). The fe also checked the tube head diagnostic screen, verified operation indicators for the axis and all locks buttons to see if there were any drop outs or erratic actuation of the buttons, but could not observe any issues in the diagnostics screen. The fe replaced the i2c board on the otc, the longitudinal brake assembly and the tube handle assembly with all the switches strictly as a precaution. The drx-evolution is back in operation after parts replacements. The parts were sent to carestream health for additional investigation. The returned parts, the longitudinal brake assembly, i2c board and the otc control handle were evaluated for mechanical function and electrical evaluation: all parts were operating as designed and reliably. The drx evolution system did not malfunction and was operating as designed and intended. Carestream health have made several attempts to contact the site biomed for additional information regarding confirmation of the nature of the tech's injury and details as to how the tech was operating the system at the time of the alleged incident; however, there has been no response from the biomed. Based on the investigation, it was determined that there have been no other similar events in the post market, it has also been determined that this incident is singular in nature. 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
Per the biomed, the tech went to move the overhead tube crane (otc) on the drx evolution (k# 54847443 / serial number (b)(4)), she pressed both all direction buttons simultaneously, tried to pull the otc to the right over to table to perform a wrist exam. As soon as she pressed the buttons, the otc did not move and allegedly causing the tech to dislocate her right shoulder: the tech was scheduled for an mri and seen by employee health after the incident. The tech is currently out of work on workman's compensation. Multiple attempts have been made by carestream health (csh) to contact the site biomed, (b)(6), for additional information regarding the severity or status of the tech's injury or how tech was operating system at time of incident; however, there has been no response back from the biomed or the site.
 
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Brand NameDRX EVOLUTION SYSTEM
Type of DeviceDRX EVOLUTION SYSTEM
Manufacturer (Section D)
CARESTREAM HEALTH INC.
150 verona street
rochester, ny
Manufacturer (Section G)
CARESTREAM HEALTH INC.
1049 ridge road west
rochester, ny
Manufacturer Contact
nancy mejias
150 verona street
rochester, ny 
6278533
MDR Report Key10418053
MDR Text Key203645683
Report Number1317307-2020-00004
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 08/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/17/2020
Is this an Adverse Event Report? Yes
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 Received07/22/2020
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: 08/17/2020 Patient Sequence Number: 1
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