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 07/23/2022

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 ireland reported via a fisher & paykel healthcare (f&p) field representative that there were sparks and smoke coming from the power cord of an pt101 airvo 2 humidifier.There was no patient involvement as the issue was found whilst the device was not in use on a patient.

Event Description

A healthcare facility in ireland reported via a fisher & paykel healthcare (f&p) field representative that there were sparks and smoke coming from the power cord of an pt101 airvo 2 humidifier.There was no patient involvement as the issue was found whilst the device was not in use on a patient.

Manufacturer Narrative

(b)(4).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.Method: the complaint pt101 airvo 2 humidifier and the associated f&p power cord were returned to fisher & paykel healthcare for evaluation.Our investigation is thus based on the evaluation of the subject pt101 airvo 2 humidifier and the associated f&p power cord, the information provided by the customer and our knowledge of the product.Results: visual inspection of the complaint airvo 2 revealed the electrical socket pins had signs of arcing and burnt marks were observed on the electrical socket cover.The power cord has signs of melting at the unit end of the plug.The complaint airvo 2 functioned correctly when powered on and there was no burning smell.The complaint airvo 2 was opened for further inspection.The pcb and components were inspected and no burnt components were observed.Conclusion: based on our investigation, it is likely the reported event of electrical arcing was caused by mechanical damage to the power cord.Our user instructions that accompany the pt101 airvo 2 humidifier state the following: never operate the unit if has a damaged power cord or plug.Avoid unnecessary removal of the power cord from the rear of the device.If the removal is necessary, hold the connector during removal.Avoid pulling on the power cord.

• 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 ; 9494534000
• MDR Report Key: 15332763
• MDR Text Key: 299181101
• Report Number: 9611451-2022-00806
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012422354
• UDI-Public: (01)09420012422354(10)2100212290(11)170508
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K131895
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 08/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2022
• 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
• Device Lot Number: 2100212290
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/08/2017
• 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