Model Number RT265 |
Device Problems
Break (1069); Crack (1135)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/14/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The complaint rt265 infant dual-heated evaqua2 breathing circuit was received at fisher & paykel healthcare (f&p) in (b)(6) but the evaluation has not yet begun.We will provide a follow-up report upon completion of our investigation.
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Event Description
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A distributor reported on behalf of a healthcare facility in (b)(4) via a fisher and paykel healthcare field representative that a rt265 infant dual-heated evaqua2 breathing circuit was found damaged at the swivel connector before use.There was no patient involvement.
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Manufacturer Narrative
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(b)(4).Method: the swivel of complaint rt265 infant dual heated evaqua2 breathing circuit was returned to fisher & paykel healthcare (f&p) in new zealand for evaluation where it was visually inspected.Results: visual inspection of device revealed a crack along one of the swivel wye port.Conclusion: the cracking is most likely occurred due to improperly mixed material.We have since contacted the supplier and arranged for them to supply the molding material with the two parts already mixed.The new pre-mixed material has now been implemented on the production line.Based on the provided lot dates, the complaint device was manufactured prior to this change.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 user instructions that accompany the rt265 also 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 reported on behalf of a healthcare facility in japan via a fisher and paykel healthcare field representative that a rt265 infant dual-heated evaqua2 breathing circuit was found damaged at the swivel connector before use.There was no patient involvement.
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Search Alerts/Recalls
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