MAUDE Adverse Event Report: ADULT INSPIRATORY HEATED BREATHING CIRCUIT; BTT

Model Number RT212

Device Problems Leak/Splash (1354); Incorrect, Inadequate or Imprecise Result or Readings (1535); Gas/Air Leak (2946)

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

Event Date 08/25/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The rt212 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 rt212 adult inspiratory-heated breathing circuit is currently en route to (b)(4) for evaluation.We will provide a follow-up report upon completion of our investigation.

Event Description

A distributor in (b)(6) reported on behalf of a healthcare facility that a rt212 adult breathing circuit failed the leak test before use on a patient.There was no patient involvement.

Manufacturer Narrative

(b)(4).The rt212 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 rt212 adult inspiratory heated breathing circuit was returned to fisher & paykel healthcare (f&p) in new zealand for evaluation where it was pressure tested.Results: pressure testing revealed that the circuit was out of specification.The water bath test revealed that the leak was through the connection between the lid and bowl of the water trap.Conclusion: we are unable to determine the cause of the reported event.The water trap of the breathing circuit consists of two parts, a lid and a bowl, which 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 that any leak must have developed after the breathing circuit was released for distribution, during transport, storage or use, possibly by distortion of the water trap when the bowl was connected.The user instructions that accompany the rt212 adult inspiratory heated 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 alarms.

Event Description

A distributor in japan reported on behalf of a healthcare facility that a rt212 adult breathing circuit failed the leak test before use on a patient.There was no patient involvement.

• Brand Name: ADULT INSPIRATORY HEATED BREATHING CIRCUIT
• Type of Device: BTT
• MDR Report Key: 10597537
• MDR Text Key: 209346836
• Report Number: 9611451-2020-00833
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012430359
• UDI-Public: 010942001243035910
• Combination Product (y/n): N
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 09/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RT212
• Device Catalogue Number: RT212
• Device Lot Number: 2101035487
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2020
• Date Manufacturer Received: 10/28/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2020
• 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