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

Model Number RT204

Device Problem Gas/Air Leak (2946)

Patient Problem No Patient Involvement (2645)

Event Date 06/10/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The rt204 adult breathing circuit is not sold in the usa but it is simliar to a product which is sold in the usa.The 510(k) for that product is k983112.The complaint rt204 breathing circuit is currently en route to fisher & paykel healthcare in (b)(4) for evaluation.We will provide a follow up report upon completion of our investigation.

Event Description

A hospital in (b)(6) reported via our distributor that an rt204 adult breathing circuit was leaking.This was found prior to patient use.

Manufacturer Narrative

(b)(4).The rt204 adult 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.Due to middle east respiratory syndrome (mers) cases in (b)(6) and the potential risk of infection,the complaint rt204 breathing circuit was not returned to fisher & paykel healthcare in (b)(6) for investigation.It was destroyed in (b)(6).Our analysis is accordingly based on the information provided by the hospital staff and a photograph of the circuit.Without the complaint device, we were unable to determine definitively the root cause of the fault reported by the hospital staff.Inspection of the photograph provided did not reveal any defect or damage to the circuit.Based on the results of our previous investigations on similar complaints, the reported leak is most likely due to a loose connection.All rt204 breathing circuits are visually inspected and pressure tested for leaks before release for distribution.Any breathing circuit which fails any of these tests is discarded.The subject breathing circuit would have met the required specification at the time of production.Our user instructions that accompany the rt204 adult breathing circuit state the following: 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.Set appropriate ventilator alarm.

Event Description

A hospital in (b)(6) reported via our distributor that an rt204 adult breathing circuit was leaking.This was found prior to patient use.

• Brand Name: ADULT DUAL-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: raymond yan ; 173 technology drive; suite 100; irvine, CA 92618 ; 9494534000
• MDR Report Key: 5774384
• MDR Text Key: 48918560
• Report Number: 9611451-2016-00306
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RT204
• Device Catalogue Number: RT204
• Device Lot Number: 150420
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2015
• 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