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

Model Number	PT100
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The subject device is no longer in use by the healthcare facility.(b)(6) has requested for the complaint device to be returned for evaluation.We will provide a follow up report upon completion of our investigation.The pt100 myairvo 2 humidifier 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 in florida 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), sections d1, d2 and d4 were corrected.The brand name and common device name (d1 and d2) were changed from airvo 2 humidifier to myairvo2 humidifier.Model number and catalog number (d4) were changed from pt101 to pt100.The pt100 myairvo 2 humidifier 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 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 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 in florida 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: 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: 15008819
• Report Number: 9611451-2022-00608
• Device Sequence Number: 2316430
• Product Code: BTT
• UDI-Device Identifier: 09420012422248
• UDI-Public: (01)09420012422248(10)2100405897(11)180201
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2022

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: 2100405897
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2022
• Supplement Date Received by Manufacturer: 08/04/2022
• Initial Report FDA Received Date: 07/13/2022
• Supplement Report FDA Received Date: 08/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2018
• 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