Model Number RT265 |
Device Problems
Crack (1135); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4) the complaint rt265 infant dual-heated evaqua2 breathing circuits are currently en-route to fph in (b)(6) for evaluation, to determine if they had a malfunction which might have caused or contributed to the reported event.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 via a fisher & paykel healthcare (fph) representative that two rt265 infant dual-heated evaqua2 breathing circuits were cracked at the 'y' connector piece.No patient consequence was reported.
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Manufacturer Narrative
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(b)(4).Method: the complaint rt265 infant dual-heated evaqua2 breathing circuits were not returned to fph in (b)(4) for evaluation.Instead, two sealed rt265 breathing circuit kits were returned and visually inspected, with one kit opened for pressure testing.Results: visual inspection revealed no damage to the returned sealed devices.The pressure test result was within specification.Conclusion: we were unable to determine what may have caused the event reported by the customer as no complaint devices were returned for investigation and no fault was found with the sealed breathing circuit kits.All rt265 infant dual-heated evaqua2 breathing circuits are visually inspected and pressure and flow tested during production, and those that fail are rejected.Our user instructions that accompany the rt265 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 hospital in (b)(6) reported via a fisher & paykel healthcare (fph) representative that two rt265 infant dual-heated evaqua2 breathing circuits were cracked at the 'y' connector piece.No patient consequence was reported.
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Search Alerts/Recalls
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