MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LIMITED ADULT DUAL HEATED BREATHING CIRCUIT

Model Number RT200

Device Problem Mechanical Problem (1384)

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

Event Date 12/27/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4) section g4: the rt200 adult dual 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.Section h11: the subject rt200 adult dual heated breathing circuit is currently en route to f&p healthcare new zealand for evaluation.We will provide a follow up report on completion of our investigation.

Event Description

A distributor reported on behalf of a healthcare facility in japan, via a fisher & paykel (f&p) healthcare field representative that the rt200 adult dual heated breathing circuit failed the ventilator leak test prior to patient use.There was no patient involvement.

Event Description

A distributor reported on behalf of a healthcare facility in (b)(6), via a fisher & paykel (f&p) field representative that a rt200 adult dual heated breathing circuit failed the ventilator leak test prior to patient use.There was no patient involvement.

Manufacturer Narrative

(b)(4).Correction: g1 updated from mr omid taheri to mr diego vargas banuelos.Section g4: the rt200 adult dual 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.Section h11: method: the subject rt200 adult dual heated breathing circuit was returned to f&p healthcare in new zealand, where it was visually inspected and leak tested.Results: visual inspection of the subject rt200 adult dual heated breathing circuit identified damage to the inspiratory elbow connector.The damage was consistent with an implement being used in an attempt to pry the collar from the connector.Leak testing confirmed that the observed damage would result in a leakage.Conclusion: our investigation was unable to determine the cause of the observed damage to the inspiratory elbow connector however witness marks indicate that it appears that an attempt had been made to remove the collar on the connector causing the observed damage.All rt200 adult dual heated breathing circuits are 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 rt200 adult dual heated breathing circuit show in pictorial format the correct set-up of the circuit and also 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 connecting to a patient." - "ensure appropriate ventilator or flow source alarms are set before connecting breathing set to patient." - "visually inspect beathing sets for damage (e.G.A crushed tube or cracked connector) before use, and replace if damaged.".

• Brand Name: ADULT DUAL HEATED BREATHING CIRCUIT
• Type of Device: HEATED BREATHING CIRCUIT
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer Contact: diego banuelos ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494341005
• MDR Report Key: 18700461
• MDR Text Key: 336424807
• Report Number: 9611451-2024-00094
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012430328
• UDI-Public: (01)09420012430328(10)2102573374(11)230404
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: SEE H11
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/15/2024

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: RT200
• Device Catalogue Number: RT200
• Device Lot Number: 2102573374
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/15/2024
• Initial Date FDA Received: 02/13/2024
• Supplement Dates Manufacturer Received: 04/22/2024
• Supplement Dates FDA Received: 05/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2023
• 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: HUMIDIFIER: MR850GJU