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

Model Number RT380

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

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

Event Date 11/25/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint rt380 adult dual-heated evaqua2 breathing circuit is currently en route to fisher & paykel healthcare (f&p) for evaluation.We will provide a follow up report upon completion of investigation.

Event Description

A distributor reported on behalf of a healthcare facility in (b)(4) that the rt380 adult dual-heated evaqua2 breathing circuit failed the ventilator pre-use check.There was no patient involvement.

Event Description

A distributor reported on behalf of a healthcare facility in japan that the rt380 adult dual-heated evaqua2 breathing circuit failed the ventilator pre-use check.There was no patient involvement.

Manufacturer Narrative

(b)(4).Method: the complaint rt380 adult dual-heated evaqua2 breathing circuit was returned to fisher & paykel healthcare (f&p) in new zealand where it was visually inspected.Results: visual inspection of the returned circuit revealed that the grommet of the rt380 adult dual-heated evaqua2 breathing circuit was incorrectly assembled in the inspiratory elbow.Conclusion: we are unable to determine the root cause of the event, however the grommet was likely incorrectly assembled during production.All rt380 adult evaqua2 breathing circuits are visually inspected and pressure and flow tested during production, and those that fail are rejected.Our user instructions that accompany the rt380 adult dual-heated evaqua2 breathing circuits 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
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer Contact: faranak gomarooni ; 173 technology dr.; suite 100; irvine, CA 92618 ; 9494534000
• MDR Report Key: 13015031
• MDR Text Key: 284901816
• Report Number: 9611451-2021-01428
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012429728
• UDI-Public: (01)09420012429728(10)2101656568(11)210602
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K103767
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/26/2021

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: RT380
• Device Catalogue Number: RT380
• Device Lot Number: 2101656568
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/26/2021
• Initial Date FDA Received: 12/15/2021
• Supplement Dates Manufacturer Received: 02/03/2022
• Supplement Dates FDA Received: 02/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2021
• 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