MAUDE Adverse Event Report: MYAIRVO HUMIDIFIER

Model Number PT100

Device Problems No Audible Alarm (1019); Inaudible or Unclear Audible Prompt/Feedback (2283)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We are currently retrieving the complaint myairvo humidifier to fisher & paykel healthcare for evaluation.We will provide a follow-up report upon completion of our investigation.

Event Description

A distributor in (b)(6) reported that the speaker of a pt100 myairvo humidifier was faulty.There was no reported patient involvement.

Event Description

A distributor in italy reported that the speaker of a pt100 myairvo humidifier was faulty.There was no reported patient involvement.

Manufacturer Narrative

(b)(4).Method: the complaint myairvo humidifier was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is thus based on the information provided by the customer and our knowledge on the product.Results: the customer reported that the speaker of the pt100 myairvo humidifier was not working.Without the complaint device, we are unable to determine the cause of the failure mode in this instance.Conclusion: as part of our ongoing product improvement initiatives, a new speaker unit has been sourced from a different supplier.The myairvo user manual states that the "myairvo is for the treatment of spontaneously breathing patients who would benefit from receiving high-flow, warmed and humidified respiratory gases" and that "the unit is not intended for life support." the user manual warns the user: prior to each patient use, ensure that the auditory alarm signal is audible by conducting the alarm system functionality check described in the alarms section the alarm system functionality check instructs the user on how to check the alarm and states that "if either alarm signal is absent, do not use the unit.Contact your fisher & paykel healthcare representative.".

• Brand Name: MYAIRVO HUMIDIFIER
• Type of Device: MYAIRVO HUMIDIFIER
• MDR Report Key: 10261727
• MDR Text Key: 199736094
• Report Number: 9611451-2020-00622
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012422194
• UDI-Public: 01094200124221941021006642071118121521181215084183
• Combination Product (y/n): N
• PMA/PMN Number: K131895
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 06/11/2020

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: Lay User/Patient
• Device Model Number: PT100
• Device Catalogue Number: PT100
• Device Lot Number: 2100664207
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/11/2020
• Initial Date FDA Received: 07/11/2020
• Supplement Dates Manufacturer Received: 08/11/2020
• Supplement Dates FDA Received: 09/08/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2018
• 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