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 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.The airvo 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 in taiwan reported 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).Corrected data: b4, d9, g3, g6, h2, h3, h6, h11.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.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) in new zealand where it was inspected by a trained f&p investigation engineer.The device was performance tested and the audible alarm function was checked.F&p's investigation is based on the information obtained from the distributor, f&p's evaluation of the subject device, previous investigations of similar complaints, and f&p's knowledge of the product.Results: during testing it was found that the myairvo 2 did not have an audible alarm, confirming the reported event.It was identified that the issue was due to a faulty speaker.Electrical resistance testing showed the speaker's resistance to be open-circuit.The speaker is a supplied component that is assembled into the myairvo 2.Conclusion: as part of ongoing product improvement initiatives, a new speaker configuration from a different supplier was implemented on 14 august 2017.Since the introduction of the new speaker, there has been a 94% reduction of the failure rate for units manufactured after 14 august 2017.Furthermore, a voluntary recall was initiated in march 2024 to remove and replace devices with the old speaker configuration.Further improvements were initiated in march 2019 which involved an update to the control pcb in order to reduce the mechanical stress on the speaker when operating.A historical search was conducted for the last 2 years which showed the speaker failure has not caused or contributed to any serious adverse events.The current failure rate per use for units manufactured after the speaker change is less than (b)(4) worldwide.
Event or Problem Description
A distributor in taiwan reported 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: 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: 23023282
• Report Number: 9611451-2025-00880
• Device Sequence Number: 9455673
• Product Code: BTT
• UDI-Device Identifier: 09420012422248
• UDI-Public: (01)09420012422248(10)2103479668(11)241120
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2026

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: 2103479668
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2025
• Supplement Date Received by Manufacturer: 01/04/2026
• Initial Report FDA Received Date: 09/11/2025
• Supplement Report FDA Received Date: 01/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2024
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown