MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD INFANT CONTINUOUS FLOW BREATHING CIRCUIT; BTT

Model Number RT132

Device Problem Infusion or Flow Problem (2964)

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

Event Type  malfunction  

Event Description

A healthcare facility in the united kingdom reported, via a fisher & paykel field representative, that the pressure line of an rt132 infant continuous flow breathing circuit was not connecting properly to a vyair ventilator.There was no patient involvement.

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.

Manufacturer Narrative

(b)(4).Method: the complaint rt132 infant continuous flow breathing circuit was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is therefore based on the information provided by the customer and our knowledge of our product.Results: the customer stated that the pressure line of an rt132 infant continuous flow breathing circuit was not connecting properly to a vyair ventilator.Conclusion: without the complaint device.We are unable to determine what may have caused the reported failure.All rt132 infant continuous flow breathing circuits are visually inspected and pressure tested prior to being released for distribution, and those that fail are rejected.The subject rt132 infant continuous flow breathing circuit would have met the required specifications at the time of production.The user instructions that accompany the rt132 infant continuous flow breathing circuit states: "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 approptiate ventilator or flow source alarms are set before connecting breathing set to patient." "visually inspect breathing sets for damage (e.G.Crushed tube or cracked connector) before use and replace if damaged." "failure to comply with any of the following warnings may impair performance of the device or compromise safety (including potentially causing serious harm)." "appropriate patient monitoring (e.G.Oxygen saturation) must be used at all times.Failure to monitor the patient (e.G.In the event of an interruption to gas flow) may result in serious harm or death.".

Event Description

A healthcare facility in the united kingdom reported, via a fisher & paykel field representative, that the pressure line of an rt132 infant continuous flow breathing circuit was not connecting properly to a vyair ventilator.There was no patient involvement.

• Brand Name: INFANT CONTINUOUS FLOW 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: 16632689
• MDR Text Key: 312428655
• Report Number: 9611451-2023-00271
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K020332
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/23/2023

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: RT132
• Device Catalogue Number: RT132
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/23/2023
• Initial Date FDA Received: 03/28/2023
• Supplement Dates Manufacturer Received: 05/24/2023
• Supplement Dates FDA Received: 05/29/2023
• 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
• Treatment: VYAIR VENTILATOR; VYAIR VENTILATOR