Model Number RT268 |
Device Problems
Leak/Splash (1354); Failure of Device to Self-Test (2937)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 03/01/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).The rt268 infant dual-heated evaqua2 breathing circuit is not sold in the usa but it is similar to a product sold in the usa.The 510(k) for that product is k103767.We are currently in the process of obtaining additional information from the customer for evaluation.We will provide a follow-up report upon completion of our investigation.
|
|
Event Description
|
A distributor in (b)(6) reported via a fisher & paykel healthcare (f&p) field representative that the rt268 infant dual-heated evaqua2 breathing circuit did not pass the ventilator leak test before patient use.There was no patient involvement.
|
|
Manufacturer Narrative
|
(b)(4).The rt268 infant dual-heated evaqua2 breathing circuit is not sold in the usa but it is similar to a product sold in the usa.The 510(k) for that product is k103767.Method: the complaint rt268 infant dual-heated evaqua2 breathing circuit was 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 rt268 infant dual-heated evaqua2 breathing circuit did not pass the ventilator leak test before patient use.Conclusion: without the complaint device, we are unable to determine what may have caused the reported event.All rt268 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 circuit would have met the required specifications at the time of production.Our user instructions that accompany the rt268 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.".
|
|
Event Description
|
A distributor in colombia reported via a fisher & paykel healthcare (f&p) field representative that the rt268 infant dual-heated evaqua2 breathing circuit did not pass the ventilator leak test before patient use.There was no patient involvement.
|
|
Search Alerts/Recalls
|