MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD ADULT INSPIRATORY HEATED BREATHING CIRCUIT; BTT

Model Number RT212

Device Problems Leak/Splash (1354); Protective Measures Problem (3015)

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

Event Date 11/05/2021

Event Type  malfunction  

Event Description

A distributor reported on behalf of a healthcare facility in (b)(6) that a (b)(4) adult inspiratory heated breathing circuit failed the ventilator leak test before use.There was no patient involvement.

Manufacturer Narrative

(b)(4).The (b)(4) 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 complaint (b)(4) adult inspiratory heated breathing circuit is currently en route to fisher & paykel healthcare (f&p) in (b)(6) for evaluation.We will provide a follow-up report upon completion of our investigation.

Manufacturer Narrative

Ps(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 (b)(4).Method: the complaint rt212 adult inspiratory heated breathing circuit was returned to fisher & paykel healthcare (f&p) in new zealand, where it was pressure tested and visually inspected.Results: pressure testing of the subject mr290 chamber was found to be out of specification.When connected to a water source, it was found that the chamber had a water leak at the connection between the spike and the tube of the water feedset.Visual inspection also revealed that there was insufficient glue coverage at the water feedset tube-spike connection of the subject chamber.Conclusion: the reported event was likely due to the insufficient glue observed at the water feedset tube-spike connection.Every mr290 chamber is pressure tested following the manufacturing process to check for any leaks present in the chamber.The pressure test is followed by a visual inspection of each chamber.Any chamber that fails this inspection is rejected.In addition, pull testing is performed periodically to verify the strength of the water feedset tubing.The subject mr290v chamber would have met the required specification at the time of production.All rt212 adult inspiratory heated breathing circuits are also visually inspected and pressure and flow tested during production, and those that fail are rejected.The subject breathing circuit would have met the required specifications at the time of production.Our user instructions that accompany the rt212 adult inspiratory heated breathing circuits state the following: - "check all connections are tight before use." - "perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient." - "set appropriate ventilator alarms.'.

Event Description

A distributor reported on behalf of a healthcare facility in japan that a rt212 adult inspiratory heated breathing circuit failed the ventilator leak test before use.There was no patient involvement.

• Brand Name: ADULT INSPIRATORY HEATED BREATHING CIRCUIT
• Type of Device: BTT
• 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 ; 173 technology dr.; suite 100; irvine, CA 92618 ; 9494534000
• MDR Report Key: 12876318
• MDR Text Key: 284695750
• Report Number: 9611451-2021-01325
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012430359
• UDI-Public: (01)09420012430359(10)2100647530(11)181127
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: SEE H10
• 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,Followup
• Report Date: 11/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RT212
• Device Catalogue Number: RT212
• Device Lot Number: 2100647530
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/12/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/27/2018
• 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