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

Model Number	PT100
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2022
Type of Reportable Event	Malfunction
Additional 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 pt100 myairvo 2 humidifier (myairvo 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 myairvo 2 device should not be used for life support purposes, and appropriate patient monitoring must be used at all times.
Event or Problem Description
A distributor reported on behalf of a patient in michigan that a pt100 myairvo 2 humidifier did not have an audible alarm.There was no patient involvement as the issue was found whilst the device was not in use on a patient.
Additional Manufacturer Narrative
(b)(4) product background: the pt100 myairvo 2 humidifier (myairvo 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 myairvo 2 device should not be used for life support purposes, and appropriate patient monitoring must be used at all times.Method: the complaint myairvo 2 was received at fisher & paykel healthcare (f&p) in new zealand where it was inspected by a trained f&p employee.The device was performance tested and the audible alarm function was checked.Our investigation is based on the information provided by the customer, our evaluation of the subject device, previous investigations of similar complaints, and our knowledge of the product.Results: performance testing revealed that the audible alarm of the myairvo 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 or Problem Description
A distributor reported on behalf of a patient in michigan that a pt100 myairvo 2 humidifier did not have an audible alarm.There was no patient involvement as the issue was found whilst the device was not in use on a patient.

• Brand Name: MYAIRVO 2 HUMIDIFIER
• Common Device Name: MYAIRVO 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: 15965571
• Report Number: 9611451-2022-01168
• Device Sequence Number: 4938764
• Product Code: BTT
• UDI-Device Identifier: 09420012422248
• UDI-Public: (01)09420012422248(10)2101683785(11)210623
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K131895
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2022

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
• Operator of Device: Lay User/Patient
• Device Model Number: PT100
• Device Catalogue Number: PT100
• Device Lot Number: 2101683785
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2022
• Supplement Date Received by Manufacturer: 01/17/2023
• Initial Report FDA Received Date: 12/13/2022
• Supplement Report FDA Received Date: 01/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/23/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown