Model Number RT385 |
Device Problem
Leak/Splash (1354)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 12/06/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).The complaint rt385 adult dual-heated evaqua2 breathing circuit is currently en route to fisher & paykel healthcare (f&p) for evaluation.We will provide a follow-up report upon completion of our investigation.
|
|
Event Description
|
A distributor reported on behalf of a healthcare facility in japan, that a rt385 adult dual-heated evaqua2 breathing circuit failed the ventilator leak test before use.There was no patient involvement.
|
|
Event Description
|
A distributor reported on behalf of a healthcare facility in japan, that a rt385 adult dual-heated evaqua2 breathing circuit failed the ventilator leak test before use.There was no patient involvement.
|
|
Manufacturer Narrative
|
(b)(4).Method: the complaint rt385 adult dual-heated evaqua2 breathing circuit was returned to fisher & paykel healthcare (f&p) in new zealand for investigation, where it was visually inspected and leak tested.Results: visual inspection identified no damage was found to any of the breathing circuits.Leak testing revealed that the breathing circuit was within specification.Conclusion: we were unable to determine what may have caused the reported event as there was no fault found with the returned device.All rt385 adult dual-heated evaqua2 breathing circuits are visually inspected, and pressure and flow tested during production, and those that fail are rejected.The subject adult breathing circuit would have met the required specifications at the time of production.Our user instructions that accompany the rt385 adult 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.".
|
|
Search Alerts/Recalls
|