Catalog Number 8065750502 |
Device Problems
Loss of Power (1475); Noise, Audible (3273)
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Patient Problem
Insufficient Information (4580)
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Event Date 08/25/2020 |
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.(b)(4).
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Event Description
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A customer reported that the system turns off intermittently.When this occurs, a noise similar to a radio out of tune is heard.
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Manufacturer Narrative
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The system was examined and the reported event was replicated.The company representative replaced the printed circuit board (pcb) to resolve the issue.The system was tested and found to meet product specifications.The manufacturing device history record (dhr) was reviewed.Based on qa assessment, the product met specifications at the time of release.The root cause of the reported event can be attributed to pcb.However, without a sample, component-level root cause cannot be determined at this time.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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