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

Model Number RT100

Device Problems Leak/Splash (1354); Failure of Device to Self-Test (2937)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/23/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The rt100 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.The complaint rt100 adult breathing circuit is currently en route to fisher & paykel healthcare (f&p) 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, via a fisher & paykel healthcare (f&p) field representative, that a rt100 adult breathing circuit failed the ventilator leak test before use.There was no patient involvement.

Event Description

A distributor in japan reported on behalf of a healthcare facility, via a fisher & paykel healthcare (f&p) field representative, that a rt100 adult breathing circuit failed the ventilator leak test before use.There was no patient involvement.

Manufacturer Narrative

Ps343524.The product referred to in the event description 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 rt100 adult breathing circuit was returned to fisher & paykel healthcare (f&p) in new zealand for investigation, where it 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 event as reported by the customer, as no fault was found with the returned device.All rt100 adult breathing circuits are visually inspected and pressure and flow tested during production, and those that fail are rejected.The subject adult breathing circuit would have met the required specifications at the time of production.Our user instructions that accompany the rt100 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 alarms.".

• Brand Name: ADULT DUAL HEATED BREATHING CIRCUIT
• Type of Device: BTT
• MDR Report Key: 10317230
• MDR Text Key: 202944519
• Report Number: 9611451-2020-00647
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012430489
• UDI-Public: 010942001243048910
• 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: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 06/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RT100
• Device Catalogue Number: RT100
• Device Lot Number: 2100849129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2020
• Date Manufacturer Received: 08/19/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/13/2019
• 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