Model Number RT265 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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A healthcare facility in new york reported, via a fisher & paykel healthcare (f&p) field representative, that the swivel of six rt265 infant dual-heated evaqua2 breathing circuits become detached prior patient use.There was no patient involvement.
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Manufacturer Narrative
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(b)(4).Device 1: lot#: 2101976941; date of manufacturing: 07-jan-2022; udi: (b)(4).Device 2: lot#: 2101934369; date of manufacturing: 04-dec-2021; udi: (b)(4).Device 3: lot#: 2102019228; date of manufacturing: 05-feb-2022; udi: not provided.Device 4: lot#: 2102043280; date of manufacturing: 20-feb-2022; udi: not provided.Device 5: lot#: 2102028621; date of manufacturing: 14-feb-2022; udi: not provided.Device 6: lot#: not provided; date of manufacturing: not provided; udi: not provided.The complaint: (b)(4).Infant dual-heated evaqua2 breathing circuits are currently en route to fisher & paykel healthcare (f&p) for evaluation.We will provide a follow-up report upon completion of our investigation.
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Manufacturer Narrative
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Ps403909 corrected data: section b5 describe event or problem: a healthcare facility in new york reported, via a fisher & paykel healthcare (f&p) field representative, that the swivel of five rt265 infant dual-heated evaqua2 breathing circuits become detached prior patient use.Section d9 device available for evaluation? no section h3 device evaluated by manufacturer? other section d4 and h4: device 1: lot#: 2101976941; date of manufacturing: 07-jan-2022; udi: (b)(4).Device 2: lot#: 2101934369; date of manufacturing: 04-dec-2021; udi:(b)(4).Device 3: lot#: 2102019228; date of manufacturing: 05-feb-2022; udi: not provided device 4: lot#: 2102043280; date of manufacturing: 20-feb-2022; udi: not provided device 5: lot#: 2102028621; date of manufacturing: 14-feb-2022; udi: not provided method: the complaint rt265 infant dual-heated evaqua2 breathing circuits were 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 the swivel of five rt265 infant dual-heated evaqua2 breathing circuits become detached prior patient use.Conclusion: without the complaint device, we are unable to determine what may have caused the reported event.All rt265 infant dual-heated evaqua2 breathing circuits are visually inspected and pressure and flow tested during production, and those that fail are rejected.The subject breathing circuits would have met the required specifications at the time of production.Our user instructions that accompany the rt265 infant dual-heated evaqua2 breathing circuit 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 healthcare facility in new york reported, via a fisher & paykel healthcare (f&p) field representative, that the swivel of five rt265 infant dual-heated evaqua2 breathing circuits become detached prior patient use.There was no patient involvement.
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Search Alerts/Recalls
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