MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD ADULT ANAESTHESIA CIRCUIT; BTT

Model Number RT116

Device Problems Use of Device Problem (1670); Blocked Connection (2888)

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

Event Date 08/19/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This product is not sold in the usa however it is similar to a product which is sold in the usa.The 510(k) for the similar product is k983112.We are currently in the process of completing our investigation.We will provide a follow up report upon completion of our investigation.

Event Description

A distributor reported on behalf of a healthcare facility in japan via a fisher and paykel healthcare (f&p) field representative, that the y-piece of a rt116 adult anaesthesia circuit was closed.There was no patient involvement.

Manufacturer Narrative

(b)(4).Section g4: this product is not sold in the usa however it is similar to a product which is sold in the usa.The 510(k) for the similar product is k983112.Method: the complaint rt116 adult anaesthesia circuit was returned to fisher & paykel healthcare (f&p) in new zealand for investigation where it was visually inspected.Results: visual inspection of returned circuit revealed that an occlusion was found inside the y-piece.Conclusion: we are unable to determine the cause of the reported event.However, it is likely that this was caused by a piece of plastic becoming trapped in the mold tool resulting to occlussive flashing.All rt116 adult anaesthesia circuits are visually inspected and pressure and flow tested during production, and those that fail are rejected.Our user instructions that accompany the rt116 adult anaesthesia circuits state the following: - "visually inspect breathing sets for damage (e.G.A crushed tube or cracked connector) before use and replace if damaged." - "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.".

Event Description

A distributor reported on behalf of a healthcare facility in japan via a fisher and paykel healthcare (f&p) field representative, that the y-piece of a rt116 adult anaesthesia circuit was closed.There was no patient involvement.

• Brand Name: ADULT ANAESTHESIA 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 dr.; suite 100; irvine, CA 92618 ; 9494534002
• MDR Report Key: 12557999
• MDR Text Key: 275141078
• Report Number: 9611451-2021-01086
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012430595
• UDI-Public: (01)09420012430595(10)2101579838(11)210330
• 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,Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 09/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RT116
• Device Catalogue Number: RT116
• Device Lot Number: 2101579838
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2021
• 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