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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AIRVO2 HUMIDIFIER
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AIRVO2 HUMIDIFIER Back to Search Results
Model Number PT101
Device Problems No Audible Alarm (1019); Inaudible or Unclear Audible Prompt/Feedback (2283)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Ps341043.The complaint device is currently in transit to fisher & paykel healthcare in (b)(6) for further 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 reported patient involvement.
 
Manufacturer Narrative
(b)(4).Method: the complaint airvo humidifier was received at f&p new zealand for investigation.Results: during testing it was found that the audible alarm did not function and electrical resistance testing has shown the speaker's resistance to be open circuit.Conclusion: as part of our ongoing product improvement initiatives, a new speaker unit has been sourced from a different supplier.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 germany reported, via a fisher & paykel healthcare (f&p) field representative, that the speaker of a pt101 airvo 2 humidifier was faulty.There was no reported patient involvement.
 
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Brand Name
AIRVO2 HUMIDIFIER
Type of Device
AIRVO2 HUMIDIFIER
MDR Report Key10187877
MDR Text Key198721249
Report Number9611451-2020-00565
Device Sequence Number1
Product Code BTT
UDI-Device Identifier09420012422286
UDI-Public01094200124222861021010589781120040221200402120168
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,foreig
Type of Report Initial,Followup
Report Date 05/25/2020
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 NumberPT101
Device Catalogue NumberPT101
Device Lot Number2101058978
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/29/2020
Initial Date Manufacturer Received 05/25/2020
Initial Date FDA Received06/24/2020
Supplement Dates Manufacturer Received07/06/2020
Supplement Dates FDA Received08/04/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/02/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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