Model Number RT206 |
Device Problems
Failure of Device to Self-Test (2937); Gas/Air Leak (2946)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/20/2022 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).We are currently in the process of completing our investigation.We will provide a follow up report upon completion of our investigation.
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Event Description
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A distributor reported on behalf of a healthcare facility in thailand, via a fisher & paykel healthcare (f&p) field representative, that a rt206 adult inspiratory heated breathing circuit failed the pre-use ventilator leak test.There was no patient involvement.
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Manufacturer Narrative
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(b)(4).Method: the complaint (b)(4) adult inspiratory heated breathing circuit was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is thus based on the information provided by the customer and our knowledge of our product.Results: the customer reported that a (b)(4) adult inspiratory heated breathing circuit failed the pre-use ventilator leak test.Conclusion: without the complaint device, we are unable to determine the cause of the reported event.All (b)(4) adult inspiratory heated breathing circuits are visually inspected and pressure and flow tested during production, and those that fail are rejected.The subject adult breathing circuit would have met the required specifications at the time of production.Our user instructions that accompany the (b)(4) adult inspiratory heated breathing circuit state the following: "check all connections are tight before use." "perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient." "ensure appropriate ventilator or flow source alarms are set before connecting breathing set to patient.".
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Event Description
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A distributor reported on behalf of a healthcare facility in thailand, via a fisher & paykel healthcare (f&p) field representative, that a (b)(4) adult inspiratory heated breathing circuit failed the pre-use ventilator leak test.There was no patient involvement.
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Search Alerts/Recalls
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