MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD AIRVO 2 HUMIDIFIER

Model Number PT101

Device Problem Sparking (2595)

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

Event Date 10/13/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Fisher & paykel healthcare (f&p) has requested for the complaint device to be returned for evaluation.We will provide a follow up report upon completion of our investigation.Product background: the pt101 airvo 2 device is an active humidifier with integrated flow generator that delivers high flow warmed and humidified respiratory gases to spontaneously breathing patients through a variety of patient interfaces.It's intended use is for the treatment of spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases.The airvo 2 device should not be used for life support purposes, and appropriate patient monitoring must be used at all times.

Event Description

A healthcare facility in new jersey reported via a fisher and paykel healthcare (f&p) field representative that a pt101 airvo 2 shorted out while on a patient, sparks and smoke were observed.There was no patient consequence.Further information regarding the reported event including the sequence of events was requested from the healthcare facility.

Event Description

A healthcare facility in new jersey reported via a fisher and paykel healthcare (f&p) field representative that a pt101 airvo 2 humidifer shorted out while on a patient.It was further reported that there was water in the heated breathing tube connection port and that the device sparked and smoke was observed.There was no patient consequence.Further information regarding the reported event including the sequence of events was requested from the healthcare facility.However, no response was provided.

Manufacturer Narrative

(b)(4).Product background: the pt101 airvo 2 humidifier (airvo 2) device is an active humidifier with integrated flow generator that delivers high flow warmed and humidified respiratory gases to spontaneously breathing patients through a variety of patient interfaces.It's intended use is for the treatment of spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases.The airvo 2 device should not be used for life support purposes, and appropriate patient monitoring must be used at all times.Method: the complaint airvo 2 was received at fisher & paykel healthcare (f&p) in new zealand where it was inspected by a trained f&p employee.Further information regarding the reported event including the sequence of events was requested from the healthcare facility on multiple occasions, however, no response was provided.Our investigation is based on the initial information provided by the customer, our evaluation of the subject device and our knowledge of the product.Results: visual inspection of the subject device revealed damage to the heated breathing tube (hbt) connection port.The hbt connection port is where the hbt connects to the airvo 2.The damage included cracking of the hbt connection port likely from being dropped and corrosion of the hbt electrical socket from water ingress.A broken pin was also observed to be stuck inside one of the hbt connection port electrical sockets.The subject airvo 2 was powered on and no further fault was found.There was no sign of damage to the pcbs.Conclusion: without further information we are unable to determine the cause of the reported event.Based on our investigation, it is likely the reported spark event was caused by mechanical damage to the hbt connection port.All airvo 2 undergo inspection during production.The subject airvo 2 would have met the required specification at the time of production.Our user instructions that accompany the pt101 airvo 2 humidifier state the following: "never operate the unit if it is not working properly" "do not store or use the unit where it can fall or be pulled into water.If water has entered the unit enclosure, disconnect the power cord and discontinue use." "never operate the unit if it has been dropped or damaged." "never operate the unit if it has been dropped into water.".

• Brand Name: AIRVO 2 HUMIDIFIER
• Type of Device: AIRVO 2 HUMIDIFIER
• 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 ; 9494534002
• MDR Report Key: 15857624
• MDR Text Key: 304342557
• Report Number: 9611451-2022-01074
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131895
• 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: 10/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PT101
• Device Catalogue Number: PT101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1