Model Number RT380 |
Device Problem
Leak/Splash (1354)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 08/12/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).We are currently in the process of completing our investigation.We will provide a follow up report upon completion of our investigation.
|
|
Event Description
|
A distributor reported on behalf of a healthcare facility in thailand, via a fisher & paykel healthcare (f&p) field representative, that a rt380 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 rt380 adult 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 stated that a rt380 adult heated evaqua2 breathing circuit failed the ventilator leak test before use.Conclusion: without the return of the complaint device, we are unable to determine the cause of the reported event.All rt380 adult 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.The user instructions that accompany the rt380 adult dual-heated evaqua2 breathing circuit state: perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient.Check all connections are tight before use.Ensure appropriate ventilator or flow source alarms are set before connecting breathing set to patient.
|
|
Event Description
|
A distributor reported on behalf of a healthcare facility in thailand, via a fisher & paykel healthcare (f&p) field representative, that a rt380 adult dual-heated evaqua2 breathing circuit failed the ventilator leak test before use.There was no patient involvement.
|
|
Search Alerts/Recalls
|