• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD AIRVO2 HUMIDIFIER

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

FISHER & PAYKEL HEALTHCARE LTD AIRVO2 HUMIDIFIER Back to Search Results
Model Number PT101
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Code Available (3191)
Event Type  malfunction  
Event Description
A hospital in (b)(6) reported "excessive rainout" while using the 900pt501 airvo breathing circuit with a pt101 airvo2 humidifier.Two incidents were noted in which patients experienced water jetting into their nose/airway, causing them to cough.One patient had to have their nasal cannula removed and was put on a trauma mask while the circuit was emptied of condensate.No further patient consequence was reported.
 
Manufacturer Narrative
(b)(4).The airvo is a humidifier with integrated flow generator that delivers warmed and humidified respiratory gases to spontaneously breathing patients through a variety of patient interfaces.The complaint airvo humidifiers are not expected to be returned to fisher & paykel healthcare (fph) (b)(4) for evaluation.There was no actual defect alleged and the hospital continues to use the subject airvos.Our investigation is based on the description of events and our knowledge of the product.Condensate in the humidification system, although not preferred, is an expected side effect of heated pass-over humidification systems in many conditions, and may vary between light misting to water droplets that form on the wall of cool breathing circuit tubing.The amount of condensate in the ventilation system is influenced by multiple setup and environmental factors.Following this incident an fph representative visited the hospital in order to provide additional training and guidance on condensate management.Our user instructions that accompany the airvo humidifier provide the following guidelines: do not use the unit when the room temperature exceeds 30 degc (86 degf) or is below 10 degc (50 degf) as the unit may switch off.Humidity output will be compromised below 18 degc (64 degf) and above 28 degc (82 degf).If excess condensation accumulates in the heated breathing tube, drain by lifting the patient end of the tube, allowing the condensate to run into the water chamber.The 900pt501 breathing circuit is expected to function correctly if the user instructions are followed correctly.It is possible that the user instructions for the 900pt501 were not followed correctly.The user instructions state the following: drain condensate from the heated limb and interface periodically.Do not place the airvo humidifier in a position that is higher than the patient.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
AIRVO2 HUMIDIFIER
Type of Device
AIRVO2 HUMIDIFIER
Manufacturer (Section D)
FISHER & PAYKEL HEALTHCARE LTD
15 maurice paykel place
east tamaki
auckland, 2013
NZ  2013
Manufacturer (Section G)
FISHER & PAYKEL HEALTHCARE LTD
15 maurice paykel place
east tamaki
auckland, 2013
NZ   2013
Manufacturer Contact
raymond yan
15365 barranca parkway
irvine, CA 92618-2216
9494534000
MDR Report Key3942804
MDR Text Key4645796
Report Number9611451-2014-00624
Device Sequence Number1
Product Code BTT
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K131895
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Nurse
Type of Report Initial
Report Date 06/18/2014
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
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/18/2014
Initial Date FDA Received07/17/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-