AIRVO 2 HUMIDIFIER PT101

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2020-03-31 for AIRVO 2 HUMIDIFIER PT101 manufactured by Fisher & Paykel Healthcare Ltd.

Event Text Entries

[187894096] (b)(4). Method: the complaint airvo humidifier was received at our fisher & paykel healthcare (f&p) regional office in (b)(4) and was inspected by a trained f&p technician. The device was performance tested and the audible alarm was checked. Results: during testing, no audible alarm was heard. Previous investigations into this type of failure have identified that the problem is caused by a faulty speaker, and electrical resistance testing has shown the speaker's resistance to be open circuit. The device was manufactured prior to the implementation of both these measures. 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 subject airvo was manufactured prior to implementation of both these measures. 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. "
Patient Sequence No: 1, Text Type: N, H10


[187894097] A healthcare facility in (b)(6) reported an issue with the pt101 airvo humidifier. Upon device assessment at fisher & paykel healthcare (f&p) regional office in (b)(4) on the 3rd of march 2020, it was found that the audible alarm was not functioning. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9611451-2020-00336
MDR Report Key9908785
Report SourceFOREIGN,USER FACILITY
Date Received2020-03-31
Date of Report2020-02-11
Date Mfgr Received2020-03-03
Device Manufacturer Date2016-01-11
Date Added to Maude2020-03-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. FARANAK GOMAROONI
Manufacturer Street173 TECHNOLOGY DRIVE SUITE 100
Manufacturer CityIRVINE, CA
Manufacturer CountryUS
Manufacturer Phone4534000142
Manufacturer G1FISHER & PAYKEL HEALTHCARE LTD
Manufacturer Street15 MAURICE PAYKEL PLACE EAST TAMAKI
Manufacturer CityAUCKLAND, 2013
Manufacturer CountryNZ
Manufacturer Postal Code2013
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameAIRVO 2 HUMIDIFIER
Generic NameAIRVO 2 HUMIDIFIER
Product CodeBTT
Date Received2020-03-31
Model NumberPT101
Catalog NumberPT101
Lot Number2100017248
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerFISHER & PAYKEL HEALTHCARE LTD
Manufacturer Address15 MAURICE PAYKEL PLACE EAST TAMAKI AUCKLAND, 2013 NZ 2013


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-31

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