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Model Number BELLAVISTA 1000E US 17,3 VENTILATOR |
Device Problem
No Display/Image (1183)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/05/2024 |
Event Type
Injury
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Manufacturer Narrative
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H3:81 other: at this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.However during recovery the same patient was placed on bv serial # (b)(6) ((b)(6) 2024) the exact same issue occurred.This report is for (b)(6).Please see (b)(4) for serial # (b)(6).Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.H3 other text : device not return yet.
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Event Description
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It was reported to vyaire medical that during surgery the bellavista1000e us 17,3" ventilator had an error message: "bellavista detected a user interface issue - decommission bv" screen.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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Search Alerts/Recalls
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