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

Model Number RT210

Device Problems Component Missing (2306); Gas/Air Leak (2946)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint rt210 infant 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 our investigation.

Event Description

A healthcare facility in illinois reported, via a fisher & paykel healthcare (f&p) field representative, that a rt210 adult dual heated breathing circuit failed the pre-use leak test.It was further reported that the grommet of the rt210 breathing circuit was found missing.There was no patient involvement.

Event Description

A healthcare facility in illinois reported, via a fisher & paykel healthcare (f&p) field representative, that a rt210 adult dual heated breathing circuit failed the pre-use leak test.It was further reported that the grommet of the rt210 breathing circuit was found missing.There was no patient involvement.

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 photograph provided by the customer, and our knowledge of the product.Results: visual inspection of the photograph provided by the customer revealed the inspiratory elbow without the grommet.Conclusion: we are unable to determine the cause of the reported event, however our investigation indicates that the device was manipulated after manufacturing as the circuit would not have passed the leak test on the production line without a grommet.All breathing circuits are visually inspected and pressure tested before leaving the production line, and those that fail are rejected.The subject breathing circuit would have met the required specifications at the 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 ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494534000
• MDR Report Key: 16624145
• MDR Text Key: 312408917
• Report Number: 9611451-2023-00261
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/03/2023

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: RT210
• Device Catalogue Number: RT210
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/03/2023
• Initial Date FDA Received: 03/27/2023
• Supplement Dates Manufacturer Received: 04/19/2023
• Supplement Dates FDA Received: 05/09/2023
• 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