MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD BI-LEVEL/CPAP INSPIRATORY HEATED CIRCUIT; BTT

Model Number RT319

Device Problem Gas/Air Leak (2946)

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

Event Date 09/07/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The rt319 adult breathing circuit is not sold in the usa but it is similar to other products sold into the usa.The 510(k) for these products 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 china via a fisher & paykel healthcare (f&p) field representative, that the temperature probe port cap of a rt319 adult bi-level cpap breathing circuit was found missing prior to patient use.There was no patient involvement.

Manufacturer Narrative

(b)(4).The rt319 adult bi-level cpap breathing circuit is not sold in the usa but it is similar to other products sold into the usa.The 510(k) for these products is k983112.Method: the subject rt319 adult bi-level cpap breathing circuit was returned to fisher & paykel healthcare (f&p) for investigation, where it was visually inspected.Results: visual inspection of the returned rt319 adult bi-level cpap breathing circuit confirmed that the blue probe port cap was found missing from patient end connector.Conclusion: we are unable to determine the cause of the reported event.All rt319 adult bi-level cpap breathing circuits are visually inspected and pressure and flow tested during production, and those that fail are rejected.The subject breathing bircuit would have met the required specification at the time of production.Our user instructions that accompany the rt319 adult bi-level cpap breathing circuit state the following: "visually inspect breathing sets for damage (e.G.A 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."."before connecting to patient, ensure that flow and pressure testing applicable to the ventilator has been completed."."check all connections are tight before use.".

Event Description

A distributor reported on behalf of a healthcare facility in china via a fisher & paykel healthcare (f&p) field representative, that the temperature probe port cap of a rt319 adult bi-level cpap breathing circuit was found missing prior to patient use.There was no patient involvement.

• Brand Name: BI-LEVEL/CPAP INSPIRATORY HEATED 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: omid taheri ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 8007923912
• MDR Report Key: 17732789
• MDR Text Key: 323227877
• Report Number: 9611451-2023-00851
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012430342
• UDI-Public: (01)09420012430342(10)2102444311(11)221130
• 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,Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RT319
• Device Catalogue Number: RT319
• Device Lot Number: 2102444311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2022
• 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