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

Model Number RT206

Device Problems Gas/Air Leak (2946); Material Split, Cut or Torn (4008)

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

Event Date 09/13/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The rt206 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 rt206 adult inspiratory heated breathing circuits are currently en route to fisher & paykel healthcare (f&p) for evaluation.We will provide a follow up report upon completion of investigation.

Event Description

A healthcare facility in (b)(6) reported, via a fisher & paykel healthcare (f&p) field representative, that two rt206 adult inspiratory heated breathing circuits failed the ventilator leak test before use.There was no patient involvement.

Manufacturer Narrative

(b)(4).The rt206 adult inspiratory heated breathing circuit is not sold in the usa but it is similar to a product which is sold in the usa.Method: the complaint rt206 adult inspiratory heated breathing circuits were returned to fisher & paykel healthcare in new zealand, where they were visually inspected.Results: visual inspection revealed a cut on the tubing of both complaint breathing circuits.The cut appeared to have been made by a sharp object.Conclusion: we are unable to determine the root cause of the reported event, however the damage appeared to be the result of the circuit bag having been opened with a knife or box cutter.All breathing circuits are visually inspected and pressure and flow tested during production, and those that fail are rejected.The subject breathing circuits would have met the required specifications at the time of production.The user instructions that accompany the rt206 adult inspiratory heated breathing circuit states the following: - check all connections are tight before use.- perform a pressure and leak test on the breathing system and check for occlusions before connection to a patient.- ensure appropriate ventilator or flow source alarms are set before connecting breathing set to patient.- visually inspect breathing sets for damage before use and replace if damaged.

Event Description

A healthcare facility in poland reported, via a fisher & paykel healthcare (f&p) field representative, that two rt206 adult inspiratory heated breathing circuits 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 drive; suite 100; irvine, CA 92618 ; 9494534000
• MDR Report Key: 12636080
• MDR Text Key: 279080058
• Report Number: 9611451-2021-01132
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012430380
• UDI-Public: (01)09420012430380(10)2101410940(11)201128
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RT206
• Device Catalogue Number: RT206
• Device Lot Number: 2101410940
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2021
• Date Manufacturer Received: 01/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/28/2020
• 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