AVANOS MEDICAL INC. BALLARD CLOSED SUCTION SYSTEMS FOR NEONATES/PEDIATRICS, Y-ADAPTER; VAP CLOSED SUCTION CATHETERS & ACCESSORIES
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Model Number 196-5 |
Device Problem
Gas/Air Leak (2946)
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Patient Problems
Bradycardia (1751); Hypoventilation (1916)
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Event Date 05/24/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The actual complaint product was not returned for evaluation.A review of the device history record is in-progress.All information reasonably known as of 06 jun 2023 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by avanos medical inc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to avanos medical inc.Avanos medical inc.Has no independent knowledge of the reported event but is relaying the information provided by the user facility where the incident occurred.This product incident is documented in the avanos medical complaint database and identified as complaint: (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical inc.Product is defective or caused serious injury.H3 other text : device not returned.
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Event Description
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It was reported, "the child desaturated and started brady carding.In arriving at the child, the caregiver realized that the trach-care was inflated and was being ventilated by the machine.He also noticed that the child did not take its volumes and had 100% leakage.The child therefore did not receive his venting properly.A colleague quickly left to look for a new trach-care to replace the defective one." per the reporter, the declaration is anonymous, and the reporter cannot provide any further information.
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Manufacturer Narrative
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The device history record for lot 30179052 was reviewed and the product was produced according to product specifications.It is not possible to determine the root cause of the reported issue without a sample as functional evaluation could not be performed in order to confirm or duplicate the reported incident.All information reasonably known as of 02 aug 2023 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by avanos medical inc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to avanos medical inc.Avanos medical inc.Has no independent knowledge of the reported event but is relaying the information provided by the user facility where the incident occurred.This product incident is documented in the avanos medical complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical inc.Product is defective or caused serious injury.
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