Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/30/2020 |
Event Type
malfunction
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Manufacturer Narrative
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No report of patient involvement.The initial reporter is located outside the u.S., and therefore this information is not provided due to country privacy laws.(b)(4).Ge healthcare investigation into the reported occurrence is ongoing.A follow-up report will be issued when the investigation has been completed.
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Event Description
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The hospital reported a flow sensor malfunction causing a loss of mechanical ventilation during a case.There was no report of patient involvement.
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Manufacturer Narrative
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A ge healthcare service representative performed a checkout of the system and confirmed the reported issue.The flow control valve and sensor interface board were replaced to resolve the issue.
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Search Alerts/Recalls
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