Catalog Number 8065750833 |
Device Problems
Component Falling (1105); Device Inoperable (1663)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/20/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is:(b)(4).
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Event Description
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A customer reported that the system falls out completely, stops working.Additional information requested but not received.
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Manufacturer Narrative
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Additional information has been provided.The system was examined and the reported event was confirmed.The switch power was replaced to resolve the issue.The system was tested and found to meet product specifications.A review of the customer¿s complaint history for the last 24 months did not show any previous complaints of this kind against the system.The system was manufactured on july 3, 2007.Based on qa assessment, the product met specifications at the time of release.The root cause of the reported event can be attributed to a non-conforming switch power.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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