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

Model Number PT100

Device Problems No Audible Alarm (1019); Noise, Audible (3273)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint myairvo humidifier is currently en route to fisher & paykel healthcare in (b)(4) for evaluation.We will provide a follow-up report upon completion of our investigation.

Event Description

A healthcare facility in (b)(6) reported that the audio alarm of a pt100 myairvo humidifier had "a slight popping sound".There was no reported patient involvement.

Event Description

A healthcare facility in new jersey reported via a fisher and paykel healthcare (f&p) representative that the audio alarm of a pt100 myairvo humidifier had "a slight popping sound".There was no reported patient involvement.

Manufacturer Narrative

Method: the complaint myairvo humidifier was recieved at fisher & paykel healthcare (f&p) in new zealand for evaluation where it was inspected by a trained f&p technician.The device was performance tested and the audible alarm was checked.Results: during testing it was found that the audible alarm was functioning normally.The customer's description of 'slight popping sound' was not replicated.The audible alarm was clear and no popping noise was observed.Conclusion: as part of our ongoing product improvement initiatives, we have implemented a soak test for 100% testing of the speaker harness on the airvo production line, which identifies and discards any faulty speakers prior to assembly into the airvo.Additionally a new speaker unit has more recently been sourced from a different supplier.The airvo user manual states that the "airvo 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 function 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
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• MDR Report Key: 8517339
• MDR Text Key: 142231046
• Report Number: 9611451-2019-00374
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• PMA/PMN Number: K131895
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 03/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2019
• 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: 150121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2019
• Date Manufacturer Received: 03/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1