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

Model Number	PT100US
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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.F&p will provide a follow up report upon completion of f&p's investigation.Product background: the pt100 myairvo 2 humidifier (myairvo 2) 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 myairvo 2 is not intended for life support, and appropriate patient monitoring must be used at all times.The myairvo 2 speaker is intended to provide auditory alerts to the user and auditory alarms under certain conditions.The user instructions instruct the user on how to check alarm functionality before use on a patient.The user instructions warn "if either alarm signal is absent, do not use the unit.Contact your fisher & paykel healthcare representative".In the case of speaker failures, a speaker will typically provide a distorted, intermittent or reduced sound level before becoming completely inaudible over time.This contributes to the early detection of this fault by users.
Event or Problem Description
A distributor reported on behalf of a customer in canada that a pt100 myairvo 2 humidifier (myairvo 2) did not have an audible alarm.There was no reported patient involvement.
Event or Problem Description
A distributor reported on behalf of a customer in canada that a pt100 myairvo 2 humidifier (myairvo 2) 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)(6).Corrected data: b4, b5, d9, g3, g6, h2, h3, h6.Product background: the pt100 myairvo 2 humidifier (myairvo 2) 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 myairvo 2 is not intended for life support, and appropriate patient monitoring must be used at all times.The myairvo 2 speaker is intended to provide auditory alerts to the user and auditory alarms under certain conditions.The user instructions instruct the user on how to check alarm functionality before use on a patient.The user instructions warn "if either alarm signal is absent, do not use the unit.Contact your fisher & paykel healthcare representative".In the case of speaker failures, a speaker will typically provide a distorted, intermittent or reduced sound level before becoming completely inaudible over time.This contributes to the early detection of this fault by users.Method: the subject myairvo 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 subject myairvo 2 was working.Conclusion: f&p are unable to determine what may have caused the reported failure as there was no fault found with the returned device.

• Brand Name: FISHER & PAYKEL HEALTHCARE
• Common Device Name: 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: diego vargas banuelos ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494341005
• MDR Report Key: 22836758
• Report Number: 9611451-2025-00784
• Device Sequence Number: 9247355
• Product Code: BTT
• UDI-Device Identifier: 09420012422248
• UDI-Public: (01)09420012422248(10)2100561876(11)180823
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Consumer,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2025

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: PT100US
• Device Catalogue Number: PT100US
• Device Lot Number: 2100561876
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2025
• Supplement Date Received by Manufacturer: 09/30/2025
• Initial Report FDA Received Date: 08/19/2025
• Supplement Report FDA Received Date: 10/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2018
• 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