VYAIRE MEDICAL, INC 3100 HIGH FREQUENCY OSCILLATORY VENTILATOR (HFOV); VENTILATOR, HIGH FREQUENCY
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Model Number 3100A |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Information (3190)
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Event Date 05/24/2018 |
Event Type
Injury
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Manufacturer Narrative
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Vyaire medical reference number (b)(4).At this time, vyaire medical has not received the suspect device/component from the customer for evaluation.In the event that the device is received for evaluation or additional information is received, a follow-up report will be submitted.
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Event Description
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The customer reported that the blender failed while the ventilator was in use on a patient.Despite what the blender knob was set to, the blender delivered 60% fio2.The end-users tried setting the blender to 21%, 50%, and 100%.The they set it at 21, 50, and 100%.The end-users removed the ventilator from the patient and hand ventilated the patient.The customer reported that there were severe complications with the patient, but did not provide any further details.
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Manufacturer Narrative
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Results of investigation: the vyaire failure analysis laboratory received the suspect device and performed a failure investigation.The reported issue was duplicated in the laboratory setting.The root cause of the reported issue revealed the loose locking nut of the front stem is not making enough contact to make an actual adjustment from 60%.
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Event Description
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The customer reported that the blender failed while the ventilator was in use on a patient.Despite what the blender knob was set to, the blender delivered 60% fio2.The end-users tried setting the blender to 21%, 50%, and 100%.The they set it at 21, 50, and 100%.The end-users removed the ventilator from the patient and manually ventilated the patient.The customer reported that there were severe complications with the patient, but did not provide any further details.
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