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

Model Number MR290V

Device Problem Overfill (2404)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/01/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device 1: lot 160409, date of manufacture april 9, 2016.Device 2: lot 140327, date of manufacture march 27, 2014.The complaint mr290v vented autofeed humidification chambers were not returned to fisher & paykel healthcare in (b)(4) for investigation as they were destroyed by the healthcare facility.Therefore, our investigation is based on the information provided by the customer, previous similar investigations and our knowledge of the product.Without the complaint device, we were unable to definitively determine the root cause of the fault reported by the hospital.A lot check revealed no other complaints of this nature for the lot numbers provided.Overfilling of water is usually caused by both the primary and secondary float mechanisms in the mr290 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 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: "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." "set appropriate ventilator alarm." "perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient.".

Event Description

A healthcare facility in (b)(6) reported via a fisher & paykel healthcare field representative that two mr290 vented autofeed humidification chambers spilled over the water level line.No patient consequence was reported.

• Brand Name: VENTED AUTOFEED 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: raymond yan ; 173 technology drive; suite 100; irvine, CA 92618 ; 8007923912
• MDR Report Key: 6077959
• MDR Text Key: 59165773
• Report Number: 9611451-2016-00739
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K934140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2016
• 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: 160409, 140327
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2014
• 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: BABYLOG VENTILATOR; PB840 VENTILATOR