IMRIS - DEERFIELD IMAGING, INC IMRIS 3T SKYRA SYSTEM; MAGNETIC RESONANCE IMAGING DEVICE
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Model Number SKYRA 3T |
Device Problems
Unintended Collision (1429); Device Handling Problem (3265)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/18/2020 |
Event Type
malfunction
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Event Description
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While moving the magnet from the operating room to the diagnostic room on (b)(6) 2020, a staff member brought in an mr-unsafe linen cart and it was drawn into the magnet.The magnet was physically damaged by the linen cart, breaking the front funnel cover, the collision detection ring, and some electrical connections inside the body coil.There was no patient involvement and the user did not sustain any injury.
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Manufacturer Narrative
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The root cause of the incident was traced to user error.This was user error by this particular staff member and was not a malfunction of the device.The front funnel cover, collision detection ring, and electrical connections to the body coil were damaged by the linen cart and were replaced.Afterwards, the system was tested to verify proper function.This mdr is being submitted outside of the required timeframe as part of remedial action initiated by the manufacturer, in response to internally identified issues regarding failed electronic submissions through webtrader.
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Search Alerts/Recalls
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