Model Number 900PT290E |
Device Problem
Crack (1135)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 03/03/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).Fisher & paykel healthcare (f&p) has requested for the complaint device be returned for evaluation.We will provide a follow up report upon completion of our investigation.Product background: the 900pt290e autofill chamber with adapter (900pt290e) is a component designed for use with the airvo 2 humidification series to provide nasal high flow (nhf) therapy.Air and oxygen are blown from the airvo 2 into the humidification chamber within which water is heated by a heater plate.The gases become humidified in the chamber and then pass into a heated breathing tube, then to the patient interface.Nhf therapy is intended for use with spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases nhf therapy should not be used for life support purposes, and appropriate patient monitoring must be used at all times.
|
|
Event Description
|
A distributor reported on behalf of a healthcare facility in china that a 900pt290e autofill chamber with adapter was found with a chamber crack before use.There was no patient involvement as the issue was found whilst the device was not in use on a patient.
|
|
Manufacturer Narrative
|
(b)(4).Product background: the 900pt290e autofill chamber with adapter (900pt290e) is a component designed for use with the airvo 2 humidification series to provide nasal high flow (nhf) therapy.Air and oxygen are blown from the airvo 2 into the humidification chamber within which water is heated by a heater plate.The gases become humidified in the chamber and then pass into a heated breathing tube, then to the patient interface.Nhf therapy is intended for use with spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases nhf therapy should not be used for life support purposes, and appropriate patient monitoring must be used at all times.Method: the complaint 900pt290e was received at fisher & paykel healthcare (f&p) for investigation, where it was visually inspected.Results: visual inspection of the returned 900pt290e revealed a crack on the dome of the chamber.There was also damage to the chamber base.Conclusion: our investigation was unable to determine the cause of the observed damage to the 900pt290e.Based on our knowledge of the product it is likely due to the chamber being subjected to an external force.Every 900pt290e is visually inspected and pressure tested throughout the manufacturing process to check for any leaks and cracks.Any chamber that fails this inspection is rejected.The subject chamber would have met the required specification at the time of production.Our user instructions that accompany the 900pt290e as part of the 900pt561 heated breathing tube and chamber kit state the following: "for single patient use only.Reuse may result in transmission of infectious substances.Attempting to reprocess will result in degradation of materials and render the product defective." "do not use the auto-fill chamber if it has been dropped or been allowed to run dry." "do not use the chamber if the water level rises above the maximum water level line." "avoid contact with chemicals, cleaning agents, or hand sanitizers.".
|
|
Event Description
|
A distributor reported on behalf of a healthcare facility in china that a 900pt290e autofill chamber with adapter was found with a chamber crack before use.There was no patient involvement as the issue was found whilst the device was not in use on a patient.
|
|
Search Alerts/Recalls
|