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

Model Number PT101

Device Problem Defective Alarm (1014)

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.The complaint device is in transit to fisher & paykel healthcare 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.Its 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 maryland reported via a fisher & paykel healthcare field representative that the audible alarm of a pt101 airvo 2 humidifier was not functioning as expected.There was no reported patient involvement.

Manufacturer Narrative

(b)(4), corrected data: g3, g6, h3, h6 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 by fisher & paykel healthcare (f&p) where it was inspected by a trained f&p employee.The device was performance tested and the audible alarm function was checked.Results: performance testing revealed that the audible alarm of the airvo 2 unit was working.Conclusion: we are unable to determine what may have caused the reported failure as there was no fault found with the returned device.

Event Description

A healthcare facility in maryland reported via a fisher & paykel healthcare field representative that the audible alarm of a pt101 airvo 2 humidifier was not functioning as expected.There was no reported patient involvement.

• 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: 18927342
• MDR Text Key: 337958767
• Report Number: 9611451-2024-00221
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012422347
• UDI-Public: (01)09420012422347(10)2100343563(11)171026
• 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
• Type of Report: Initial,Followup
• Report Date: 02/20/2024

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: 2100343563
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/20/2024
• Initial Date FDA Received: 03/18/2024
• Supplement Dates Manufacturer Received: 04/07/2024
• Supplement Dates FDA Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2017
• 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