Model Number RT308 |
Device Problem
Gas/Air Leak (2946)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/29/2022 |
Event Type
malfunction
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Event Description
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A distributor reported on behalf of a healthcare facility in south korea that a rt308 adult heated oxygen therapy kit failed the pre-use leak test.There was no patient involvement.
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Manufacturer Narrative
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(b)(4).We are currently in the process of finalising our investigation.We will send a follow up report upon completion of our investigation.
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Manufacturer Narrative
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(b)(4).Method: the complaint rt308 adult heated oxygen therapy kit 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 the product.Results: the customer reported that a rt308 adult heated oxygen therapy kit failed the pre-use leak test.Conclusion: without the return of the complaint device, we are unable to determine the cause of the reported event.All rt308 adult heated oxygen therapy kits are visually inspected, and pressure and flow tested during production, and those that fail are rejected.The subject breathing circuit would have met the required specifications at the time of production.Our user instructions that accompany the rt308 adult heated oxygen therapy kit show in pictorial format the correct set-up of the circuit and also states 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 south korea that a rt308 adult heated oxygen therapy kit failed the pre-use leak test.There was no patient involvement.
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Search Alerts/Recalls
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