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

Model Number RT206

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 04/07/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A healthcare facility in china reported that the temperature probe port cap of a rt206 adult inspiratory heated breathing circuit was found damaged prior to patient 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.The 510(k) for that product is k983112.Method: the complaint rt206 adult inspiratory heated breathing circuit was returned to fisher & paykel healthcare (f&p) in new zealand for investigation, where it was visually inspected and analyzed.Results: visual inspection of the return device revealed that the inspiratory elbow port cap tether was found broken and the port cap was missing.However, we are unable to determine when the port cap went missing.Conclusion: the leak the customer experienced was due to the use with a mr810 respiratory humidifier.This indicates that the customer was trying to use the circuit without a temperature probe.The rt206 adult inspiratory heated breathing circuit is intended to be used with mr850 respiratory humidifier.The mr850 temperature probe inserted in the probe port would have sealed the port.A corrective action has now been implemented on the production line to prevent the tether from breaking during assembly.Based on the provided lot dates, the complaint device was manufactured prior to this change.All rt206 adult inspiratory heated breathing circuits are pressure and flow tested during production, and those that fail are rejected.A breathing circuit without the port cap would fail the final leak test before the packing station.This suggests that the port cap went missing after it had been distributed.Our user instructions that accompany the rt206 adult inspiratory heated breathing circuit show in pictorial format the correct set-up of the circuit and also states the following: - "compatible with fisher & paykel healthcare mr850 humifiers." - "the use of breathing circuits, chambers, accessories, or combinations which are not approved by fisher&paykel healthcare may result in poor humidification system performance, ventilator malfunction and harm to the patient/user." - "visually inspect breathing sets for damage (e.G.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." - "perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient." - "check all connections are tight before use.".

Event Description

A healthcare facility in china reported that the temperature probe port cap of a rt206 adult inspiratory heated breathing circuit was found damaged prior to patient 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 ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494534000
• MDR Report Key: 17070175
• MDR Text Key: 316696452
• Report Number: 9611451-2023-00454
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012430380
• UDI-Public: (01)09420012430380(10)2102219382(11)220613
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/09/2023

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: RT206
• Device Catalogue Number: RT206
• Device Lot Number: 2102219382
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/09/2023
• Initial Date FDA Received: 06/06/2023
• Supplement Dates Manufacturer Received: 07/07/2023
• Supplement Dates FDA Received: 07/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2022
• 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: F&P MR810 RESPIRATORY HUMIDIFIER.; F&P MR810 RESPIRATORY HUMIDIFIER.