Model Number VITAL SIGNS® INFANT FACE MASK SIZE 2 |
Device Problem
Defective Component (2292)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 11/08/2021 |
Event Type
Injury
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Event Description
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The customer reported that the vital signs® infant face mask size 1 and 2 ring was deflated when removed from the bag.Sample was pulled to use in emergent situations, deflation causes delay in patient care.As an intervention, the clinicians had to get syringe and fill mask with air before being able to rescue ventilate child.
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Manufacturer Narrative
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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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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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Event Description
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The customer reported that the vital signs® infant face mask size 1 and 2 ring was deflated when removed from the bag.Sample was pulled to use in emergent situations, deflation causes delay in patient care.As an intervention, the clinicians had to get syringe and fill mask with air before being able to rescue ventilate child.
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Search Alerts/Recalls
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