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

Model Number RT205

Device Problem Air Leak (1008)

Patient Problem No Patient Involvement (2645)

Event Date 06/14/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Pma/510(k): the rt205 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.Manufacturer narrative: we are currently in the process of obtaining the complaint rt205 adult inspiratory heated breathing circuit from the hospital for investigation to determine if it had a malfunction, which could have caused or contributed to the reported leak.We will provide a follow up report once we have completed our evaluation.

Event Description

A hospital in (b)(6) reported via a distributor that an rt205 adult inspiratory heated breathing circuit failed the ventilator leak test.This was observed before use on a patient.

Manufacturer Narrative

(b)(4).Pma/510(k) the rt205 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.Method: the complaint rt205 adult inspiratory heated breathing circuit was returned to fisher & paykel healthcare in (b)(6) for investigation.It was visually inspected, pressure tested, and submerged in a water bath to check for leaks.Results: the pressure test revealed that the returned breathing circuit was out of specification.The water bath test showed that the leak was through the connection between the lid and bowl of the expiratory water trap.Conclusion: the water trap of the rt205 adult inspiratory heated breathing circuit consists of a bowl and a lid.The water trap bowl and lid can be separated to allow the caregiver to empty the water trap.All breathing circuits are pressure tested for leaks during production and those that fail are rejected.This suggests any leak must have developed after the product was released for distribution, during transport or storage.The respiratory therapist had correctly checked the breathing circuit for leak before patient use, which is in line with our user instructions.The user instructions that accompany the rt205 adult inspiratory heated breathing circuit state the following: "perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient." "set appropriate ventilator alarms.".

Event Description

A hospital in (b)(6) reported via a distributor that an rt205 adult inspiratory heated breathing circuit failed the ventilator leak test.This was observed before use on a patient.

• Brand Name: ADULT INSPIRATORY HEATED BREATHING CIRCUIT
• Type of Device: BTT
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, auckland 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, auckland 2013 ; NZ 2013
• Manufacturer Contact: sharon kuruvilla ; 173 technology dr., suite 100; irvine; 9494534000
• MDR Report Key: 6796232
• MDR Text Key: 83012386
• Report Number: 9611451-2017-00750
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: PM
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Respiratory Therapist
• Type of Report: Initial,Followup
• Report Date: 07/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RT205
• Device Catalogue Number: RT205
• Device Lot Number: 2100189300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2017
• 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