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

Model Number MR290V

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); No Apparent Adverse Event (3189)

Patient Problem No Patient Involvement (2645)

Event Date 07/29/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The rt212 adult inspiratory-heated breathing circuit is not sold in the usa but it is similar to a product which is sold in the usa.The 510(k) for that product is k983112.The complaint device rt212 adult inspiratory heated breathing circuit is currently en route to fisher & paykel healthcare (f&p) (b)(4) for evaluation.We will provide a follow-up report upon completion of our investigation.

Event Description

A distributor in (b)(6) reported that the rt212 adult breathing circui failed the ventilator leak test before use on a patient.There was no patient involvement.

Manufacturer Narrative

(b)(4).Method: the complaint mr290v autofeed humidification chamber from the rt212 adult inspiratory-heated breathing circuit kit was returned to fisher & paykel healthcare in new zealand for investigation.The returned chamber was visually inspected and functionally tested by connecting it to a water source.Results: visual inspection of the returned complaint mr290v chamber identified no damage to the chamber dome and water feedset.When connected to a water source, it was found that the device had a water leak at the connection between the spike and the tube of the water feedset.Conclusion: we are unable to determine what caused the reported event, as the chamber dome 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 hinders 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.".

Event Description

A distributor in japan reported that the rt212 adult breathing circuit kit failed the ventilator leak test before use on a patient.There was no patient involvement.

• Brand Name: VENTED AUTOFEED HUMIDIFICATION CHAMBER
• Type of Device: BTT
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• MDR Report Key: 9388016
• MDR Text Key: 178796817
• Report Number: 9611451-2019-01145
• 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: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 10/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2019
• 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: 180813
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2019
• Date Manufacturer Received: 01/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1