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U.S. Department of Health and Human Services

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

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FISHER & PAYKEL HEALTHCARE LTD AIRVO 2 HUMIDIFIER Back to Search Results
Model Number PT101
Device Problems No Audible Alarm (1019); Defective Component (2292)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The complaint pt101 airvo humidifier is expected but have not yet been returned to fisher & paykel healthcare.We will submit a follow up report upon completion of our investigation.
 
Event Description
A distributor in (b)(4) reported, via a fisher & paykel healthcare (f&p) representative, that the speaker of a pt101 airvo humidifier was faulty.There was no patient involvement.
 
Event Description
A distributor in saudi arabia reported, via a fisher & paykel healthcare (f&p) representative, that the speaker of a pt101 airvo humidifier was faulty.There was no patient involvement.
 
Manufacturer Narrative
(b)(4).Method: the complaint airvo humidifier was not received for evaluation.Our investigation is based on the customer's description of events.Results: the customer has stated that the speaker of a pt101 airvo humidifier was faulty.Conclusion: previous investigations into audio alarm failures 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.As part of our ongoing product improvement initiatives, we have implemented a soak test for (b)(4) 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." 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 and states that "if either alarm signal is absent, do not use the unit.Contact your fisher & paykel healthcare representative.".
 
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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 Key8548379
MDR Text Key143606880
Report Number9611451-2019-00409
Device Sequence Number1
Product Code BTT
UDI-Device Identifier09420012422286
UDI-Public(01)09420012422286(10)2100057854(11)160622
Combination Product (y/n)N
PMA/PMN Number
K131895
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 03/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/25/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberPT101
Device Catalogue NumberPT101
Device Lot Number2100057854
Was Device Available for Evaluation? No
Date Manufacturer Received07/05/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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