MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD AIRVO2 HUMIDIFIER

Model Number PT101

Device Problems No Audible Alarm (1019); Defective Component (2292)

Patient Problem No Patient Involvement (2645)

Event Date 01/15/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint airvo 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 a fault with a pt101 airvo2 humidifier.During assessment of the device at the fisher & paykel healthcare (f&p) service center in (b)(4) on 29 january 2019 it was found that the speaker was faulty.There was no patient involvement.

Manufacturer Narrative

Ps299749 method: the complaint airvo humidifier was received at fisher & paykel healthcare (f&p) in new zealand for evaluation.The device was performance tested, and the audible alarm function was checked.The was no fault found with the speaker.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 test the alarm and states that "if either alarm signal is absent, do not use the unit.Contact your fisher & paykel healthcare representative.".

Event Description

A healthcare facility in texas reported a fault with a pt101 airvo2 humidifier.During assessment of the device at the fisher & paykel healthcare (f&p) service center in irvine, california on (b)(6)2019 it was found that the speaker was faulty.There was no patient involvement.

• Brand Name: AIRVO2 HUMIDIFIER
• Type of Device: AIRVO2 HUMIDIFIER
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• MDR Report Key: 8376411
• MDR Text Key: 137844398
• Report Number: 9611451-2019-00167
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012422347
• UDI-Public: (01)09420012422347(10)2100015170(11)151221
• Combination Product (y/n): N
• PMA/PMN Number: K131895
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 01/18/2019

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: Health Professional
• Device Model Number: PT101
• Device Catalogue Number: PT101
• Device Lot Number: 2100015170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2019
• Initial Date Manufacturer Received: 01/29/2019
• Initial Date FDA Received: 02/27/2019
• Supplement Dates Manufacturer Received: 03/13/2019
• Supplement Dates FDA Received: 04/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1