MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LIMITED OPTIFLOW JUNIOR TUBING KIT; BTT

Model Number RT330

Device Problems Device Slipped (1584); Gas/Air Leak (2946)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint rt330 optiflow junior tubing kit is currently en route to fisher & paykel healthcare (f&p) in new zealand for evaluation.We will provide a follow up report upon completion of investigation.

Event Description

A healthcare facility in (b)(6) reported via a fisher and paykel healthcare (f&p) field representative, that the temperature probe was "popping out" of the inspiratory limb of a rt330 optiflow junior tubing kit during use.There was no patient consequence.

Manufacturer Narrative

(b)(4).Corrected data: section d9 device available for evaluation? no.Section h3 device evaluated by manufacturer? other.Method: the complaint rt330 optiflow junior tubing kit was not returned to fisher & paykel healthcare (f&p) in new zealand for investigation.Our investigation is thus based on the information provided by the customer and our knowledge of the product.Results: customer reported that the temperature probe was "popping out" of the inspiratory limb of a rt330 optiflow junior tubing kit during use.Conclusion: without the complaint device, we are unable to determine the cause of the reported event.All rt330 optiflow junior tubing kits are visually inspected and pressure and flow tested during production, and those that fail are rejected.Our user instructions that accompany the rt330 optiflow junior tubing kit 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." - "ensure appropriate ventilator or flow source alarms are set before connecting breathing set to patient.".

Event Description

A healthcare facility in iowa reported via a fisher and paykel healthcare (f&p) field representative, that the temperature probe was "popping out" of the inspiratory limb of a rt330 optiflow junior tubing kit during use.There was no patient consequence.

• Brand Name: OPTIFLOW JUNIOR TUBING KIT
• 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 ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494534000
• MDR Report Key: 14164003
• MDR Text Key: 294605675
• Report Number: 9611451-2022-00377
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012431066
• UDI-Public: (01)09420012431066(10)2100948093(11)191126
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020332
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RT330
• Device Catalogue Number: RT330
• Device Lot Number: 2100948093
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/26/2019
• 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