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

Model Number MR290V

Device Problem Overfill (2404)

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

Event Date 07/26/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method: the complaint mr290v vented autofeed humidification chamber was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is thus based on the information and photographs provided by the customer and our knowledge of the product.Results: visual inspection of the provided photographs identified that the water in the mr290v vented autofeed humidification chamber was above the maximum water level line.Conclusion: without the complaint device, we are unable to determine the cause of the reported event.Water filling over the maximum water level line indicates that primary float may have failed to regulate the flow of water into the chamber as intended.However, 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 mr290v vented autofeed humidification chambers are functionally tested during production.Any chamber that failed is rejected.The subject mr290v chamber would have met the required specification at the time of production.The user instructions that accompany the mr290v 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: -"when mounting a humidifier adjacent to a patient, ensure that the humidifer is always positioned lower than the patient." - "do not operate the chamber at an angle in excess of 10°" - "do not spike the water source until the blue caps have been removed.Should the primary float fail, splashing into the circuit may occur if the chamber is being operated in excess of 80l/min.".

Event Description

A distributor reported on behalf of a healthcare facility in china that the mr290v vented autofeed humidification chamber had water filling above the maximum water level line.There was no patient consequence.

• 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
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer Contact: faranak gomarooni ; 17400 laguna canyon drive; suite #300; irvine, CA 92618 ; 9494534000
• MDR Report Key: 15246778
• MDR Text Key: 298218528
• Report Number: 9611451-2022-00769
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K934140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MR290V
• Device Catalogue Number: MR290V
• Device Lot Number: 2101169184
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/26/2022
• 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
• Treatment: F&P RT266 INFANT EVAQUA2 BREATHING CIRCUIT