Model Number RT380 |
Device Problems
Leak/Splash (1354); No Apparent Adverse Event (3189)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The complaint rt380 circuits are currently en route to fisher & paykel healthcare (f&p) in (b)(4) for evaluation.We will provide a follow up report upon completion of our investigation.
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Event Description
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A hospital in (b)(6) reported that four rt380 adult dual heated evaqua2 breathing circuits did not pass the ventilator leak test before patient use.There was no patient involvement.
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Event Description
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A hospital in france reported that four rt380 adult dual heated evaqua2 breathing circuits did not pass the ventilator leak test before patient use.There was no patient involvement.
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Manufacturer Narrative
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Ps296703 two complaint rt380 adult evaqua2 breathing circuits were returned to fph in new zealand for investigation, where they were visually inspected and pressure tested.Results: visual inspection revealed no damage to the returned breathing circuits and drylines.The pressure test revealed that the subject breathing circuits were within specification.Conclusion: we were unable to determine what may have caused the leak as reported by the customer as no fault was found with the returned devices.All rt380 adult evaqua2 breathing circuits are visually inspected and pressure and flow tested during production, and those that fail are rejected.The subject infant breathing circuits would have met the required specifications at the time of production.Our user instructions that accompany the rt380 adult evaqua2 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." - "set appropriate ventilator alarms.'.
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Search Alerts/Recalls
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