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

Model Number RT210

Device Problems Disconnection (1171); Leak/Splash (1354); Connection Problem (2900)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We are currently in the process of completing our investigation.We will provide a follow up report upon completion of our investigation.

Event Description

A healthcare facility in (b)(6) reported via a fisher & paykel healthcare (f&p) field representative, that the heater wire moulded plug of three rt210 adult dual-heated breathing circuits disconnected during use.There was no patient consequence.

Event Description

A healthcare facility in (b)(6) reported via a fisher & paykel healthcare (f&p) field representative, that the heater wire moulded plug of three rt210 adult dual-heated breathing circuits disconnected during use.There was no patient consequence.

Manufacturer Narrative

(b)(4).We are currently in the process of completing our investigation.We will provide a follow up report upon completion of our investigation.

Event Description

A healthcare facility in ohio reported via a fisher & paykel healthcare (f&p) field representative, that the heater wire moulded plug of three rt210 adult dual-heated breathing circuits disconnected during use.There was no patient consequence.

Manufacturer Narrative

(b)(4), method: the complaint rt210 adult dual-heated breathing circuit was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is thus based on the information and photographs provided by the customer, and our knowledge of the product.Results: visual inspection of the photographs revealed that the expiratory heater wire moulded plug of rt210 circuit was loose.Conclusion: without the complaint device, we are unable to determine the cause of the reported event.All breathing circuits are visually inspected and pressure tested before leaving the production line, and those that fail are rejected.The subject breathing circuits would have met the required specifications at time of production.The user instructions that accompany the rt210 adult dual-heated breathing circuitt 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 connection to a patient.Ensure appropriate ventilator or flow source alarms are set before connecting breathing set to patient.Visually inspect breathing sets for damage before use and replace if damaged.

• 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
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LTD; 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: 13237486
• MDR Text Key: 286011393
• Report Number: 9611451-2022-00013
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K983112
• 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: 12/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RT210
• Device Catalogue Number: RT210
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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