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

Model Number PT101

Device Problem Sparking (2595)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The subject device is no longer in use by the healthcare facility.Fisher & paykel (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 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.

Event Description

A distributor in malaysia reported via a fisher and paykel healthcare (f&p) field representative that a pt101 airvo 2 humidifier generated a spark during use.There were no reported patient consequences.Further information regarding the reported event, including the sequence of events, was requested from the healthcare facility.

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 device was not returned to fisher & paykel healthcare (f&p) for evaluation.Several attempts to request further information from the distributor were made, including the sequence of events and device set-up.However, no response was provided.Our investigation is based on the initial information provided by the distributor, previous investigations of similar complaints, and our knowledge of the product.Results: the distributor reported that the pt101 airvo 2 generated a spark during use.There were no reported patient consequences.Conclusion: without the return of the subject device, our investigation was unable to determine the cause of the reported event.All f&p airvo 2 humidifiers undergo inspection during production.The reported airvo 2 device would have met the required specification at the time of production.Our user instructions which accompany the pt101 airvo 2 humidifier state the following: - avoid unnecessary removal of the power cord from the rear of the device.- avoid pulling on the power cord.- appropriate patient monitoring must be used at all times.

Event Description

A distributor in malaysia reported via a fisher and paykel healthcare (f&p) field representative that a pt101 airvo 2 humidifier generated a spark during use.There were no reported patient consequences.F&p requested further information regarding the reported event, however no response was provided.

• Brand Name: AIRVO 2 HUMIDIFIER
• Type of Device: RESPIRATORY 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: omid taheri ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 8007923912
• MDR Report Key: 18088806
• MDR Text Key: 328238515
• Report Number: 9611451-2023-01040
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012422354
• UDI-Public: (01)09420012422354(10)2101111541(11)200512
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: K131895
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/11/2023

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: PT101
• Device Catalogue Number: PT101
• Device Lot Number: 2101111541
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/11/2023
• Initial Date FDA Received: 11/07/2023
• Supplement Dates Manufacturer Received: 12/17/2023
• Supplement Dates FDA Received: 01/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2020
• 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