AVANOS MEDICAL INC. BALLARD 1500 FLEX HEAT AND MOISTURE EXCHANGER; VAP AIRWAY CIRCUIT DRAINS, HME & ACCESSORIES
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Model Number 150 |
Device Problem
Loose or Intermittent Connection (1371)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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The product involved in the report has been returned and is being processed for evaluation.A review of the device history record is in-progress.All information reasonably known as of 09-dec-2019 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.Avanos medical, inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the avanos medical, inc.Complaint database and identified as complaint (b)(4).
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Event Description
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Avanos medical, inc.Received a single report that referenced two different incidences, which were associated with separate units, involving two different events.This is the second of two reports.Refer to 3011270181-2019-00073 for the first event.The small end of the integrated flex tube was too big for the patients endotracheal (et) tube and it slipped off due to a bad connection.There was no reported injury.Additional information received 21-nov-2019 stated the patient was intubated; as the clinicians went to put the heat moisture exchange (hme) on the et tube it would not stay and "popped off" as the clinicians began delivering gas during surgery.The device was replaced for a new device.There were no reported injuries.
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Manufacturer Narrative
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One used sample was received for evaluation.There was no obvious damage and the filter was found to be in place.The device history record for lot 2019-04-15 was reviewed and the product was produced according to product specifications.The root cause was determined to be supplier related.All information reasonably known as of 06 apr 2020 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 event reported but is relaying the information that was 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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