Catalog Number 595000-001 |
Device Problems
Appropriate Term/Code Not Available (3191); Audible Prompt/Feedback Problem (4020)
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Patient Problems
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/08/2023 |
Event Type
malfunction
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Event Description
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The patient had red alarm.He was sitting and all parameters were normal.Received clarification on 17aug2023 from (b)(6) on why returning 2 freedom drivers: "yes, both of them had red alarm and he had to switch twice.".
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Manufacturer Narrative
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Freedom drivers will be investigated; results will be provided in a follow up mdr.
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Event Description
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The patient had red alarm.He was sitting and all parameters were normal.Received clarification on 17aug2023 from borivoj on why returning 2 freedom drivers: "yes, both of them had red alarm and he had to switch twice.".
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Search Alerts/Recalls
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