Model Number RT266 |
Device Problem
Material Integrity Problem (2978)
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Patient Problem
No Patient Involvement (2645)
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Event Date 06/26/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The complaint rt266 breathing circuit is currently en route to fisher & paykel healthcare in (b)(4) for investigation.We will provide a follow up report upon conclusion of our investigation.
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Event Description
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A distributor in (b)(4) reported that an rt266 infant dual-heated evaqua2 breathing circuits was exhibiting leak when connected to a ventilator and there were holes in the tubing.This was found before patient use.
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Manufacturer Narrative
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(b)(6) method: the complaint rt266 breathing circuit was not returned to fisher & paykel healthcare in (b)(6) for investigation.Our investigation is based on information and a photograph provided and our knowledge of the product.Results: the photograph showed that the inspiratory limb of the circuit was damaged and appeared to have a series of small holes in a section of the tubing.Conclusions: without a device to examine, we are unable to determine the exact nature and cause of the reported damage.However we were informed by our india office that the damage most likely occurred while the product was in stoirage at the distributor's facility or during transport from the distributor to the customer.All rt266 infant dual-heated evaqua2 breathing circuits are visually inspected and pressure and flow tested during production, and those that fail are rejected.The healthcare facility reported that the damage was observed during use, which suggests that the complaint breathing circuits became damaged after they were released for distribution.Our user instructions that accompany the rt266 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.Set appropriate ventilator alarms.
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Event Description
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A distributor in (b)(6) reported that an rt266 infant dual-heated evaqua2 breathing circuits was exhibiting leak when connected to a ventilator and that there were holes in the tubing.This was found before patient use.
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Search Alerts/Recalls
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