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

Model Number PT101

Device Problems No Audible Alarm (1019); No Apparent Adverse Event (3189)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint pt101 airvo humidifier is currently in transit to fisher & paykel healthcare (f&p) 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 via a fisher & paykel healthcare (f&p) field representative that the speaker of a pt101 airvo 2 humidifier was faulty.There was no patient consequence.

Event Description

A healthcare facility in (b)(6) reported via a fisher & paykel healthcare (f&p) field representative that the speaker of a pt101 airvo 2 humidifier was faulty.There was no patient consequence.

Manufacturer Narrative

(b)(4).Method: the complaint pt101 airvo humidifier was returned to fisher & paykel healthcare (f&p) in new zealand for evaluation.The device was visually inspected and electrically tested.Results: visual inspection revealed no damage to the device.During testing it was found that the device was working properly.No fault was found with the device.Conclusion: we were unable to determine the cause of the reported issue, as the complaint pt101 airvo humidifier was found to be operating correctly.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: AIRVO 2 HUMIDIFIER
• Type of Device: AIRVO 2 HUMIDIFIER
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• MDR Report Key: 8400876
• MDR Text Key: 139086053
• Report Number: 9611451-2019-00209
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012422347
• UDI-Public: 09420012422347
• 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,health
• Type of Report: Initial,Followup
• Report Date: 02/08/2019

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: 2100482854
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2019
• Initial Date Manufacturer Received: 02/08/2019
• Initial Date FDA Received: 03/07/2019
• Supplement Dates Manufacturer Received: 03/29/2019
• Supplement Dates FDA Received: 04/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1