Model Number 3100A |
Device Problem
Unexpected Shutdown (4019)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/27/2023 |
Event Type
malfunction
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Event Description
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It was reported to vyaire medical that the 3100a ventilator shut down while on a patient and was not able to power back up.The customer confirmed that there is no patient harm associated with this reported event.
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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.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
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Manufacturer Narrative
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Result of investigation: vyaire field service went onsite, unit turns on and runs, however takes long time for reset to activate and alarm silence does not function.Unit has 12,450 hours on the timer.As a resolution performed patient circuit calibration and performance check then unit off.Biomed manager states this unit has been retired and will not be used ever again.Stated the cost was too great to move forward with 12k pm of exchange.
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Search Alerts/Recalls
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