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

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.

• Brand Name: DRX EVOLUTION SYSTEM
• Type of Device: DRX 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 Key: 10418053
• MDR Text Key: 203645683
• Report Number: 1317307-2020-00004
• 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: 08/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/22/2020
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other