Model Number BELLAVISTA 1000 US |
Device Problem
Computer Software Problem (1112)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/29/2021 |
Event Type
Injury
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Manufacturer Narrative
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At this time, the suspected device and log file has not been returned for evaluation.Therefore, root cause has not been determined yet.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 1000 us had a software malfunction.The screen went black during use on patient.The unit was pulled out with no patient harm or injury as reported.
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Manufacturer Narrative
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Results of investigation: analysis on the log file shows that the issue was most likely due a faulty epc.The exact root cause could not be established.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
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Search Alerts/Recalls
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