Model Number IFLOW 200 S PROXIMAL FLOW SENSOR (ADULT/PEDIATRIC, SINGLE-PATIENT, 1 PACK=10 PC) |
Device Problem
Disconnection (1171)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/24/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Vyaire medical file identification: (b)(4).At this time, the suspect component/device has not been returned for evaluation.No root cause has not been determined yet.This complaint is link to manufacturer's reference number: (b)(4).Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
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Event Description
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The customer reported to vyaire medical that the green component of the iflow 200 s was disconnected from main part of the flow sensor happened prior connecting the patient to ventilator.The customer confirmed that there was a delay in connecting while waiting for another flow sensor yet no patient harm was reported.Three (3) out of 10 sensors were defective which confirmed happened into three(3) separate patients.
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Manufacturer Narrative
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Results of investigation: the suspect component was not returned for investigation.Vyaire medical determined root cause as due to a defective iflow 200 s single-use proximal flow sensor.Most likely the rough handling, the exact root cause is unknown.Initiated iflow sensor replacement and the issue resolved.
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Search Alerts/Recalls
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