VYAIRE MEDICAL, INC 3100 HIGH FREQUENCY OSCILLATORY VENTILATOR (HFOV); VENTILATOR, HIGH FREQUENCY
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Model Number 3100A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Respiratory Acidosis (2482)
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Event Date 11/29/2017 |
Event Type
Injury
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Manufacturer Narrative
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(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 it was almost impossible to ventilate the patient even though maximum adjustments were chosen.The patient's co2 value increased.The end-users decreased the piston movement, the amplitude, and the frequency, and set the power to 10.The patient's situation did not improve.The patient was placed on another ventilator and the patient's condition improved.The patient's co2 value dropped and the replacement ventilator could be set to more regular values with good amplitude.There was no permanent injury to the patient.
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Manufacturer Narrative
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The vyaire medical factory service center received the suspect device, a 3100a ventilator, for evaluation.An evaluation of the device verified the reported issue and found that the driver and pr3 regulator were defective.The factory service center replaced the driver the pr3 regulator and performed a complete calibration and checkout.The device meets manufacturer's specifications.
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