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Model Number 2110 |
Device Problem
Device Alarm System (1012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/15/2024 |
Event Type
malfunction
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Manufacturer Narrative
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H3: device not received, by manufacturer.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56, when additional reportable information becomes available.
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Event Description
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It was reported, the device exhibited a descending alarm on power down, after pogo pin insulator replacement was completed.There was a descending alarm to eventual silence sounded on power down.The event occurred, during immediately on use.There was no patient involvement.
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Manufacturer Narrative
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No product was returned.We are unable to confirm the reported complaint.If the product is returned, the manufacturer will reopen this complaint for further investigation.The root cause was unable to be established.The service history review had no indication that the complaint was related to a service of the device within the review period.
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Search Alerts/Recalls
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