MAUDE Adverse Event Report: VENTED HUMIDIFICATION CHAMBER; AUTOFEED CHAMBER

Model Number 900PT290E

Device Problems Filling Problem (1233); Overfill (2404)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/13/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We are currently in the process of finalising our investigation.We will provide a follow up report upon completion of investigation.

Event Description

A healthcare facillity in (b)(6) reported that the 900pt290e humidification chamber had water filling above the maximum fill line.There was no reported patient consequences.

Manufacturer Narrative

(b)(4).Method: the complaint 900pt290e humidification chamber was not returned to fisher & paykel healthcare 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 900pt290e humidification chamber had water filling above the maximum fill line.Conclusion: without the complaint device, we are unable to determine what has caused the reported event.Overfilling of water is usually caused by both the primary and secondary float mechanisms in the 900pt290e humidification chamber being disabled.In circumstances where the primary float is disabled, the water may overfill above the black water level line of the chamber but the secondary float will serve as a backup to prevent the water from overflowing outside the chamber port and entering into the breathing circuit.All 900pt290e humidification chamber have float function and valve testing performed twice during production.A failure of any test would result in rejection of the chamber before distribution.The subject chamber would have met the required specification at the time of production.Our user instructions that accompany the 900pt290e autofeed chamber state the following: - "do not use the chamber if the water rises above the maximum water level line" - "ensure that there is a water supply connected to the chamber and that water in the chamber is below the maximum water level line:".

Event Description

A healthcare facillity in indiana reported that the 900pt290e humidification chamber had water filling above the maximum fill line.There was no reported patient consequences.

• Brand Name: VENTED HUMIDIFICATION CHAMBER
• Type of Device: AUTOFEED CHAMBER
• MDR Report Key: 11335809
• MDR Text Key: 241943335
• Report Number: 9611451-2021-00170
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• PMA/PMN Number: K131895
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 01/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 900PT290E
• Device Catalogue Number: 900PT290E
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1