Model Number BELLAVISTA 1000E |
Device Problem
Display or Visual Feedback Problem (1184)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/17/2021 |
Event Type
Injury
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Manufacturer Narrative
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At this time, the suspect device has not been returned for evaluation.However, log files has been sent and analyzed by technical support.It was suspected that this issue was related to sw patch 16.No root cause has been determined yet because the investigation is still on going.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
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Event Description
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The customer reported that the bellavista 1000e screen went blank and when it came back on error messages shows "return to manufacture settings".The device continued to operate and never stopped ventilating.The issue occurred during patient-use and the device was replaced with another ventilator.The customer confirmed that there was no patient harm associated with the reported event.
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Manufacturer Narrative
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Result of investigation: it was determined that the root cause of the issue was the software bug in improved internal o2 sensor communication handling found in v6.0.1600.0.This issue is resolved with v6.0.1700.0.
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Search Alerts/Recalls
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