Model Number 3100A |
Device Problem
Defective Component (2292)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/02/2024 |
Event Type
malfunction
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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.H3 other text : device not returned yet.
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Event Description
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It was reported to vyaire medical that the 3100a ventilator piston stopped while device was on a patient.The customer confirmed that there is no patient harm associated with this reported event.
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Manufacturer Narrative
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Result of investigation: vyaire field service went onsite performed 2k pm (preventive maintenance) on the unit.The power supply, alarm board, pneumatics and performance check all passed.The pressure transducer, ddi driver controller board and patient circuit calibrations all passed.Unit is ready for patient use.
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Search Alerts/Recalls
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