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

Model Number RT212

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

Patient Problem No Patient Involvement (2645)

Event Date 01/29/2020

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 was recently received at fisher & paykel healthcare (f&p) (b)(4).We will provide a follow up report upon completion of investigation.

Event Description

A distributor reported on behalf of a healthcare facility in (b)(6) that a rt212 adult breathing circuit failed the ventilator 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) new zealand and was visually inspected and pressure tested.Results: visual inspection revealed no damage to the returned breathing circuit or the dryline.The pressure test also revealed that the breathing circuit was within specification.Conclusion: we were unable to determine what may have caused the reported event, as no fault was found with the returned device.All rt212 adult inspiratory heated breathing circuits are visually inspected and pressure and flow tested during production, and those that fail are rejected.The subject infant breathing circuit would have met the required specifications at the time of production.Our 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 reported on behalf of a healthcare facility in japan that a rt212 adult breathing circuit failed the ventilator 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: 9887164
• MDR Text Key: 187423793
• Report Number: 9611451-2020-00326
• 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: 02/27/2020

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: RT212
• Device Catalogue Number: RT212
• Device Lot Number: 2100604417
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2020
• Initial Date Manufacturer Received: 02/27/2020
• Initial Date FDA Received: 03/26/2020
• Supplement Dates Manufacturer Received: 03/29/2020
• Supplement Dates FDA Received: 04/28/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/08/2018
• 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