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

Model Number PT101

Device Problems No Audible Alarm (1019); Improper Flow or Infusion (2954)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We are currently attempting to determine whether our device caused or contributed to the reported event.We are in contact with the hospital to obtain more information.We will provide a follow-up/final report upon completion of our investigation.

Event Description

A hospital in (b)(6) reported that a pt101 airvo humidifier stopped working while connected to a patient.There was no reported patient consequence.

Manufacturer Narrative

(b)(4).Method: the complaint airvo humidifier was returned to fisher & paykel healthcare in new zealand where it was visually inspected, performance tested, and electrically tested.Results: during testing the airvo powered on and the blower was found to be fully functioning; the reported fault was not able to be replicated.Visual alarms were also functioning, however, no audible alarm was heard.The fault of the audible alarm was traced to a faulty speaker and electrical resistance testing showed that the speaker's resistance was open circuit.Conclusion: we are unable to determine what caused the reported event as the device was found to be operating within specification except for the faulty speaker.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 subject airvo was manufactured prior to implementation of the new 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." additionally, the airvo user manual instructs the user to "use continuous oxygen monitoring on patients who would desaturate significantly in the event of disruption to their oxygen supply." 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 hospital in the uk reported that a pt101 airvo 2 humidifier stopped working while connected to a patient.Upon evaluation of the airvo, the device was found to be delivering therapy wtihin specification, however it was discovered that the speaker was not working.There was no reported patient consequence.

• 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: 7795859
• MDR Text Key: 117607211
• Report Number: 9611451-2018-00696
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012422354
• UDI-Public: (01)09420012422354(10)2100108026(11)161121
• 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: 07/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2018
• 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: 2100108026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2018
• Date Manufacturer Received: 07/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1