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

Model Number PT100

Device Problems Device Alarm System (1012); Noise, Audible (3273)

Patient Problem No Patient Involvement (2645)

Event Date 03/27/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint pt100 myairvo humidifier is currently en route to fisher & paykel healthcare (f&p) for evaluation.We are in process to determine if f&p product caused or contributed to the reported event.We will provide a follow up report upon completion of our investigation.

Event Description

A healthcare facility in (b)(6) reported via fisher & paykel healthcare field representative that an pt100 myairvo humidifier makes a faulty sound when powering on.There was no patient involvement.

Event Description

A healthcare facility in finland reported via fisher & paykel healthcare field representative that an pt100 myairvo humidifier makes a faulty sound when powering on.There was no patient involvement.

Manufacturer Narrative

(b)(4).To lay user/patient.Method: the complaint myairvo humidifier was received at fisher & paykel healthcare (f&p) new zealand for investigation.The device was visually inspected and the speaker was tested.Results: visual inspection did not reveal any external damage on the complaint myairvo.The speaker of the complaint device was working as intended.Conclusion: as part of our ongoing product improvement initiatives, we have implemented a soak test for 100% testing of the speaker harness on the myairvo production line, which identifies and discards any faulty speakers prior to assembly into the myairvo.Additionally a new speaker unit has more recently 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 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: 8614235
• MDR Text Key: 145299900
• Report Number: 9611451-2019-00492
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 04/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2019
• 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: 2100608778
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2019
• Date Manufacturer Received: 07/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1