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

Model Number RT206

Device Problems Leak/Splash (1354); Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 11/01/2021

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 circuit is currently en route to fisher & paykel healthcare (f&p) in (b)(4) for evaluation.We will provide a follow up report upon completion of investigation.

Event Description

A distributor reported on behalf of a healthcare facility in (b)(4) via a fisher & paykel healthcare (f&p) field representative, that a rt206 adult inspiratory heated breathing circuit 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.The 510(k) for that product is k983112.Method: the complaint rt206 adult inspiratory heated breathing circuit was returned to fisher & paykel healthcare in new zealand, where it was pressure tested.Results: pressure testing revealed that the circuit was out of specification.The water bath test revealed that the leak was through the connection between the lid and bowl of the water trap.Conclusion: we are unable to determine the cause of the reported event.The water trap of the breathing circuit consists of two parts where the lower part can be removed during use for draining water.The water trap leak was located at the connection between the water trap bowl and the water trap lid.All breathing circuits are pressure tested for leaks during production and those that fail are rejected.This suggests that any leak must have developed after the breathing circuit was released for distribution, during transport, storage or use, possibly by distortion of the water trap when the bowl was connected.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.

Event Description

A distributor reported on behalf of a healthcare facility in japan via a fisher & paykel healthcare (f&p) field representative, that a rt206 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 drive; suite 100; irvine, CA 92618 ; 9494534000
• MDR Report Key: 12876164
• MDR Text Key: 282491857
• Report Number: 9611451-2021-01294
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012430380
• UDI-Public: (01)09420012430380(10)2101466792(11)210116
• 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,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/09/2021

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: 2101466792
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/10/2021
• Initial Date FDA Received: 11/25/2021
• Supplement Dates Manufacturer Received: 12/10/2021
• Supplement Dates FDA Received: 12/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/16/2021
• 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