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

Model Number RT200

Device Problem Gas/Air Leak (2946)

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

Event Date 04/02/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The rt200 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 rt200 adult dual-heated breathing circuit was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is based on the information and photographs provided by the customer and our knowledge of the product.Results: visual inspection on the provided photographs revealed that the grommet of the rt200 adult dual-heated breathing circuit was missing from the inspiratory elbow.Conclusion: without the complaint device, we are unable to determine the cause of the missing grommet.All rt200 adult dual-heated breathing circuits are leak tested during production and those that fail are rejected.The subject rt200 adult dual-heated breathing circuit would have met the required specification at the time of production.The user instructions that accompany the rt200 adult dual-heated breathing circuit state: "ensure appropriate ventilator or flow source alarms are set before connecting breathing set to patient.".

Event Description

A healthcare facility in (b)(6) reported via the (b)(4) national medical products administration (nmpa) reporting system, that a rt200 adult dual-heated breathing circuit was found to be leaking when connected to the ventilator before patient use.It was further reported that the grommet on the inspiratory elbow was found missing.There was no patient involvement.

• 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
• MDR Report Key: 11781478
• MDR Text Key: 252229801
• Report Number: 9611451-2021-00538
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012430410
• UDI-Public: (01)09420012430410(10)2101067334(11)20040
• 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: foreign,health professional,o
• Type of Report: Initial
• Report Date: 04/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RT200
• Device Catalogue Number: RT200
• Device Lot Number: 2101344312
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/06/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2020
• 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