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

Model Number MR290V

Device Problems Leak/Splash (1354); No Apparent Adverse Event (3189)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We are currently in contact with the customer to obtain the complaint device for evaluation.We will provide a follow up report upon completion of the investigation.

Event Description

A healthcare facility in (b)(6) reported to a fisher & paykel healthcare (f&p) field representative that an mr290v vented autofeed humidification chamber was leaking.There was no reported patient consequence.

Event Description

A healthcare facility in texas reported to a fisher & paykel healthcare (f&p) field representative that three mr290v vented autofeed humidification chambers were leaking.There was no reported patient consequence.

Manufacturer Narrative

(b)(4).Section h4 device manufacture dates are (lot/batch - date of manufacturing mm/dd/yyyy) 181011 - 10/11/2018, 190226 - 02/26/2019, 190111 - 01/11/2019.Method: three complaint mr290 vented autofeed humidification chambers were returned to fisher & paykel healthcare in new zealand for investigation.The returned chambers were visually inspected and functionally tested by connecting them to a water source.Results: visual inspection of the three returned complaint mr290 chambers identified no visible damage to the chamber dome and water feedset.When connected to a water source, it was found that the devices had a water leak at the connection between the spike and the tube of the water feed set.Conclusion: we were unable to conclusively determine what caused the reported event, as the chamber dome itself was not damaged and did not leak.The only identified leak during investigation was found at the connection between the water feedset tube and the spike.A water feedset damage is not a reportable event as confirmed by us fda in august 2014 based on the medical device reporting guidance document of 1997.Our review of complaints data confirmed that there is no documentation of any reported serious injuries or deaths in the last 5 years and the probability of harm occurring is remote, with 0 complaints of injury or death out of ~ 30.4 million chambers sold.A damaged water feedset is most commonly detected during the standard setup and ventilator test before use on a patient.A damaged water feedset hinder water from entering the chamber.The breathing circuit still connects to the ventilator and delivers medical gases to the patient.There is no interference with the delivery of medical gases, only the humidifying of it.In addition, when connected to our most common humidifier (model mr850), a water out alarm will sound if the chamber runs out of water.This will alert hospital staff to check the water level.Every mr290 chamber is pressure tested following the manufacturing process to check for any leaks present in the chamber dome due to cracks and other causes.Any chamber which fails this test is rejected.In addition, the pressure test is followed by a visual inspection of each chamber.No cracks in the chamber dome are acceptable.Any chamber that fails this inspection is rejected.The subject mr290v chamber would have met the required specification at the time of production.Our user instructions that accompany the mr290v vented autofeed humidification chamber state the following: - "do not soak, wash, sterilize, or reuse this product.Avoid contact with chemicals, cleaning agents, or hand sanitizers." - "set appropriate ventilator alarms." - "perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient." - "ensure there is a water supply connected to the chamber and that water is present within the chamber.".

• Brand Name: VENTED AUTOFEED 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: 9176960
• MDR Text Key: 177179426
• Report Number: 9611451-2019-00968
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• PMA/PMN Number: K934140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/11/2019

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: MR290V
• Device Catalogue Number: MR290V
• Device Lot Number: 181011,190226,190111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2019
• Initial Date Manufacturer Received: 09/11/2019
• Initial Date FDA Received: 10/10/2019
• Supplement Dates Manufacturer Received: 01/05/2020
• Supplement Dates FDA Received: 01/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1