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Model Number ORT300 |
Device Problem
Unintended Movement (3026)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/11/2019 |
Event Type
malfunction
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Manufacturer Narrative
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An imris customer service engineer (cse) was on-site to resolve the issue.The cse removed and replaced the roll cylinder in the or table and the cylinder was returned for evaluation.During inspection, it was discovered that the cylinder was manufactured from an old design where the o-ring seal was of a lower durometer material resulting in decreased durability.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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Event Description
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On (b)(6), 2019, the customer reported that the ort300 table drifted left.The event occurred during daily qa and there was no patient involvement.
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Search Alerts/Recalls
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