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

Model Number RT109

Device Problem Disconnection (1171)

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

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.The complaint rt109 adult anaesthesia circuit is currently en route to fisher & paykel healthcare (f&p) for evaluation.We will provide a follow-up report upon completion of our investigation.

Event Description

A heathcare facility in (b)(6) reported via a fisher and paykel healthcare (f&p) field representative, that the connection between the y-piece and a rt109 adult anaesthesia circuit disconnected before use.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 rt109 adult anaesthesia circuit was returned to fisher & paykel healthcare (f&p) in new zealand where it was visually inspected.Results: visual inspection of returned circuit revealed that one of the limbs was found loose at the y-piece end.No damage was found to the y-piece or the tube cuffs.It was also noted that a tight connection between the tube and the connector was found at the connector end of both limbs.Conclusion: we were unable to determine what may have caused the reported failure mode at this stage.All rt109 adult anaesthesia 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.The user instructions that accompany the rt109 adult anaesthesia circuit state the following: - "check all connections are tight before use." - "ensure appropriate ventilator or flow source alarms are set before connecting breathing set to patient." - "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.".

Event Description

A heathcare facility in switzerland reported via a fisher and paykel healthcare (f&p) field representative, that the connection between the y-piece and a rt109 adult anaesthesia circuit disconnected before use.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 ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494534002
• MDR Report Key: 13444074
• MDR Text Key: 287531567
• Report Number: 9611451-2022-00106
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012430441
• UDI-Public: (01)09420012430441(10)2101594259(11)210412
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/24/2022

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: RT109
• Device Catalogue Number: RT109
• Device Lot Number: 2101594259
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/24/2022
• Initial Date FDA Received: 02/03/2022
• Supplement Dates Manufacturer Received: 05/16/2022
• Supplement Dates FDA Received: 05/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2021
• 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