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

Model Number RT102

Device Problem Disconnection (1171)

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

Event Date 11/11/2021

Event Type  malfunction  

Event Description

A distributor reported on behalf of a healthcare facility in (b)(6) via a fisher and paykel healthcare (f&p) field representative, that the connector of two rt102 adult inspiratory-heated breathing circuits disconnected during set-up.There was no patient involvement.

Manufacturer Narrative

(b)(4).The rt102 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.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 connector of two rt102 adult inspiratory-heated breathing circuits disconnected during set-up.There was no patient involvement.

Manufacturer Narrative

Ps384828, the rt102 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.The complaint rt102 adult inspiratory-heated breathing circuits were not returned to f&p for evaluation.Our investigation is thus based on the information and photograph provided by the customer and our knowledge of the product.Results: visual inspection of the provided photograph showed the patient end connector not fully inserted into the inspiratory tube.Conclusion: without the complaint device, we are unable to determine the cause of the reported event.All rt102 adult inspiratory-heated breathing circuits are visually inspected and pressure and flow tested during production, and those that fail are rejected.The subject circuit would have met the required specifications at the time of production.Our user instructions that accompany the rt102 adult inspiratory-heated breathing 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.".

• 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 dr.; suite 100; irvine, CA 92618 ; 9494534002
• MDR Report Key: 12900967
• MDR Text Key: 282823236
• Report Number: 9611451-2021-01358
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012430557
• UDI-Public: (01)09420012430557(10)2101614778(11)210427
• 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: 11/19/2021

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: RT102
• Device Catalogue Number: RT102
• Device Lot Number: 2101614778
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/19/2021
• Initial Date FDA Received: 11/30/2021
• Supplement Dates Manufacturer Received: 12/07/2021
• Supplement Dates FDA Received: 12/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2021
• 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