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

Model Number MR290VX

Device Problem Overfill (2404)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint mr290vx vented autofeed humdification chamber is currently en-route to fisher & paykel healthcare for evaluation.We will provide a follow up report upon completion of our investigation.

Event Description

A healthcare facility in finland reported via a fisher and paykel healthcare (f&p) field representative, that a mr290vx vented autofeed humidification chamber was overfilled during patient use.There was no reported patient consequence.

Event Description

A healthcare facility in finland reported via a fisher and paykel healthcare (f&p) field representative, that a mr290vx vented autofeed humidification chamber was overfilled during patient use.There was no reported patient consequence.

Manufacturer Narrative

(b)(4).Method: the complaint mr290vx vented autofeed humidification chamber was returned to fisher & paykel healthcare (f&p) in new zealand where it was visually inspected and analysed.Results: visual inspection of the returned mr290vx chamber revealed no damage on the chamber.It was also noted that the floats were moving freely and no obstructions or loose items within the chamber.Water level test was carried out and confirmed that the primary and secondary float actual water level are within specification.The complaint mr290vx chamber was functioning as intended.Conclusion: we are unable to confirm the reported event as there was no fault found with the returned mr290vx chamber.Overfilling of water is usually caused by both the primary and secondary float mechanisms in the mr290vx vented autofeed 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 mr290vx vented autofeed humidification 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 mr290vx vented autofeed 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: - "ensure appropriate ventilator or flow source alarms are set before connecting breathing set to patient." - "perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient.".

• Brand Name: VENTED AUTOFEED HUMIDIFICATION CHAMBER
• Type of Device: AUTOFEED CHAMBER
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer Contact: faranak gomarooni ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494534000
• MDR Report Key: 14973904
• MDR Text Key: 296857795
• Report Number: 9611451-2022-00617
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K934140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MR290VX
• Device Catalogue Number: MR290VX
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/06/2022
• Initial Date FDA Received: 07/10/2022
• Supplement Dates Manufacturer Received: 10/17/2022
• Supplement Dates FDA Received: 10/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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