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Model Number VELA |
Device Problem
Mechanical Problem (1384)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/03/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The customer reported that they will not return the defective pcb (printed circuit board) for evaluation.Therefore, no root cause could be determined.However, the customer is requesting a new main control pcb (printed circuit board) for replacement.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information was received.
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Event Description
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The customer reported to vyaire medical that the vela ventilator was showing "circuit disconnect, xdcr/transducer fault, low ve/low minute ventilation, high rate" alarm continuously.The reporter confirmed that there is no patient involvement associated on this event.
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Search Alerts/Recalls
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