MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD BI-LEVEL/CPAP INSPIRATORY HEATED CIRCUIT; BTT

Model Number RT219

Device Problem Disconnection (1171)

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

Event Type  malfunction  

Event Description

A healthcare facility in canada reported via a fisher & paykel healthcare (f&p) field representative that "several" rt219 adult bi-level/cpap breathing circuits disconnected during use.It was reported that the devices being used for hypercapnic patients who were confused and pulling the mask causing a disconnection between the mask and the breathing circuit.There was no reported patient consequence.

Manufacturer Narrative

(b)(4).We are currently in the process of completing our investigation.We will provide a follow up report upon completion of our investigation.

Manufacturer Narrative

(b)(6), (b)(6) method: the complaint rt219 adult bi-level/cpap breathing circuits were not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is thus based on the information provided by the customer and our knowledge of the product.Results: the customer reported that "several" rt219 adult bi-level/cpap breathing circuits disconnected during use.It was reported that the devices were being used for hypercapnic patients who were confused and pulling the mask causing a disconnection between the mask and the breathing circuit.Conclusion: without the complaint device, we are unable to determine what may have caused the reported event.The rt219 adult bi-level/cpap breathing circuit complies with international standard iso 5356-1:2015 (breathing circuit conical connectors).All rt219 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.Our user instructions that accompany the rt219 adult bi-level/cpap breathing circuit show in pictorial format the correct set-up of the circuit and also state the following: - "appropriate patient monitoring (e.G.Oxygen saturation) must be used at all times.Failure to monitor the patient (e.G.In the event of an interruption to gas flow) may result in serious harm or death." - "failure to comply with the following warnings may impair performance of the device or compromise safety (including potentially cause serious harm:" - "visually inspect breathing sets for damage (e.G.A crushed tube or cracked connector) before use and replace if damaged." - "ensure appropriate ventilator or flow source alarms are set before connecting breathing set to patient." - "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.".

Event Description

A healthcare facility in canada reported via a fisher & paykel healthcare (f&p) field representative that "several" rt219 adult bi-level/cpap breathing circuits disconnected during use.It was reported that the devices were being used for hypercapnic patients who were confused and pulling the mask causing a disconnection between the mask and the breathing circuit.There was no reported patient consequence.

• Brand Name: BI-LEVEL/CPAP INSPIRATORY HEATED 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 ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494534000
• MDR Report Key: 15644116
• MDR Text Key: 302426107
• Report Number: 9611451-2022-00946
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K983112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RT219
• Device Catalogue Number: RT219
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: ECG LEADS AND SPO2 MONITORS; ECG LEADS AND SPO2 MONITORS; F&P NON-VENTED HOSPITAL FULL FACE MASK; F&P NON-VENTED HOSPITAL FULL FACE MASK; F&P VENTED HOSPITAL FULL FACE MASK; F&P VENTED HOSPITAL FULL FACE MASK; V60 VENTILATOR; V60 VENTILATOR