Model Number CI-1400-02H |
Device Problems
Mechanical Problem (1384); Intermittent Communication Failure (4038)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Type
malfunction
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Manufacturer Narrative
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Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.
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Event Description
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The recipient is reportedly experiencing sound quality issues.Device testing revealed abnormal results.The recipient is not using the device.Advanced bionics is still in the process of obtaining additional information.When additional information is received, a supplemental report will be submitted.
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Manufacturer Narrative
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External equipment was exchanged, however the issue did not resolve.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.
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Manufacturer Narrative
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Advanced bionics considers the investigation into this reportable event as closed.The recipient will remain a non user of the device.This device is considered a failure in situ.A review of the device history record was performed and no anomalies were noted.No further details will be provided.This is the final report.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.
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Search Alerts/Recalls
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