MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD VENTED HUMIDIFICATION CHAMBER; AUTOFEED CHAMBER

Model Number 900PT290E

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

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint (b)(4) chamber is currently en route to fisher & paykel healthcare (b)(4) for evaluation.We will provide a follow up report upon completion of our investigation.

Event Description

A healthcare facility in (b)(6) reported via a fisher & paykel healthcare (f&p) representative that a 900pt290e humidification chamber was overfilled.There was no patient involvement.

Event Description

A healthcare facility in sweden reported via a fisher & paykel healthcare (f&p) representative that a 900pt290e humidification chamber was overfilled.There was no patient involvement.

Manufacturer Narrative

(b)(4).Method: the complaint 900pt290 humidification chamber was returned to fisher & paykel healthcare (f&p) in new zealand for investigation.Visual inspection and water level testing of the returned 900pt290 chamber was performed.Results: visual inspection revealed no damage to the chamber.The floats were found to be moving freely.During the functional test, the water level of both primary and secondary floats was checked.Both floats operated correctly, and the water level attained was within specification.Conclusion: we were unable to determine the cause of the reported issue, as the complaint mr290 chamber was found to be operating correctly.Overfilling of water is usually caused by both the primary and secondary float mechanisms in the mr290 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 mr290 chambers 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 user instructions that accompany the mr290 humidification chamber specify in the warning section "do not use the chamber if the water rises above the maximum water level line" along with a diagram directing the user to check the water level on the chamber.A written description of the meaning of the symbols used is also included in the user instructions.It also states the following: "set appropriate ventilator alarm." "perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient.".

• Brand Name: VENTED HUMIDIFICATION CHAMBER
• Type of Device: AUTOFEED CHAMBER
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• MDR Report Key: 8825752
• MDR Text Key: 152205341
• Report Number: 9611451-2019-00702
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2019
• 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: 2100563738
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2019
• Date Manufacturer Received: 10/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 900PT561 F&P BREATHING CIRCUIT KIT.; 900PT561 F&P BREATHING CIRCUIT KIT.; PT101 F&P AIRVO 2 HUMIDIFIER.; PT101 F&P AIRVO 2 HUMIDIFIER.; 900PT561 F&P BREATHING CIRCUIT KIT; PT101 F&P AIRVO 2 HUMIDIFIER