Humidifier, Respiratory Gas, (direct Patient Interface)

Device Code: 26

Product Code(s): BTT

Device Classification Information

Device Type ID26
Device NameHumidifier, Respiratory Gas, (direct Patient Interface)
Regulation DescriptionRespiratory Gas Humidifier.
Regulation Medical SpecialtyAnesthesiology
Review PanelAnesthesiology
Premarket Review Office Of Device Evaluation (ODE)
Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID)
Respiratory Devices Branch (RPDB)
Submission Type510(k)
CFR Regulation Number868.5450 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeBTT
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

Total Product Life Cycle

Device Type ID26
DeviceHumidifier, Respiratory Gas, (direct Patient Interface)
Product CodeBTT
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionRespiratory Gas Humidifier.
CFR Regulation Number868.5450 [🔎]
Premarket Reviews
ManufacturerDecision
CAREFUSION
 
SUBSTANTIALLY EQUIVALENT
1
FISHER & PAYKEL HEALTHCARE LTD
 
SUBSTANTIALLY EQUIVALENT
1
FISHER & PAYKEL HEALTHCARE LTD.
 
SUBSTANTIALLY EQUIVALENT
2
FISHER & PAYKEL HEALTHCARE NZ LTD
 
SUBSTANTIALLY EQUIVALENT
1
GRUENDLER GMBH
 
SUBSTANTIALLY EQUIVALENT
1
HAMILTON
 
SUBSTANTIALLY EQUIVALENT
2
HAMILTON MEDICAL AG
 
SUBSTANTIALLY EQUIVALENT
2
PACIFIC MEDICO CO., LTD.
 
SUBSTANTIALLY EQUIVALENT
1
SALTER LABS
 
SUBSTANTIALLY EQUIVALENT
1
TELEFLEX MEDICAL
 
SUBSTANTIALLY EQUIVALENT
3
TELEFLEX MEDICAL , INC.
 
SUBSTANTIALLY EQUIVALENT
1
TELEFLEX MEDICAL, INC
 
SUBSTANTIALLY EQUIVALENT
1
TELEFLEX, INC.
 
SUBSTANTIALLY EQUIVALENT
3
Device Problems
No Audible Alarm
2066
Power Problem
226
Failure To Power Up
185
Leak / Splash
175
Connection Problem
168
Crack
160
Device Operates Differently Than Expected
151
Temperature Problem
127
Device Alarm System
95
Insufficient Heating
87
Overheating Of Device
50
Device Issue
46
Device Handling Problem
26
Device Stops Intermittently
23
Adverse Event Without Identified Device Or Use Problem
21
No Flow
19
Device Sensing Problem
19
No Display / Image
17
Melted
17
Hole In Material
17
Fitting Problem
16
False Alarm
15
Break
14
Fluid Leak
13
Insufficient Information
13
Disconnection
13
Air Leak
13
Moisture Or Humidity Problem
12
Protective Measures Problem
11
Failure Of Device To Self-Test
11
Failure To Deliver
11
Appropriate Term/Code Not Available
10
Kinked
10
Detachment Of Device Or Device Component
10
Overfill
9
Loss Of Or Failure To Bond
7
Failure To Sense
7
Restricted Flow Rate
7
Pressure Problem
7
Detachment Of Device Component
6
Device Emits Odor
6
Cut In Material
6
Tear, Rip Or Hole In Device Packaging
6
No Apparent Adverse Event
6
Use Of Device Problem
5
Device Displays Incorrect Message
4
Filling Problem
4
Loose Or Intermittent Connection
4
Breathing Circuit
4
Partial Blockage
3
Defective Alarm
3
Thermal Decomposition Of Device
3
No Device Output
3
Torn Material
3
Noise, Audible
3
Occlusion Within Device
3
Difficult To Open Or Close
3
Physical Property Issue
3
Obstruction Of Flow
3
Device Operational Issue
3
Infusion Or Flow Problem
3
Human-Device Interface Problem
2
Bent
2
Burst Container Or Vessel
2
Fire
2
Material Integrity Problem
2
Material Discolored
2
Improper Or Incorrect Procedure Or Method
2
Delivered As Unsterile Product
2
Circuit Failure
2
Electrical /Electronic Property Problem
2
Failure To Reset
2
Improper Flow Or Infusion
2
Failure To Align
2
Split
2
Device Slipped
2
Display Or Visual Feedback Problem
2
Material Separation
2
Folded
1
Computer Operating System Problem
1
Flowmeter
1
Loss Of Power
1
Unexpected Shutdown
1
Power Cord
1
Decrease In Pressure
1
Reflux Within Device
1
Device Contamination With Chemical Or Other Material
1
Improper Alarm
1
Device Contaminated During Manufacture Or Shipping
1
Material Deformation
1
Inaudible Or Unclear Audible Prompt / Feedback
1
Electrical Shorting
1
Mechanical Problem
1
Connection Error
1
Adapter (Adaptor)
1
Probe
1
Stretched
1
Microbial Contamination Of Device
1
Inaccurate Delivery
1
Housing
1
Total Device Problems 4047
Recalls
Manufacturer Recall Class Date Posted
1
Teleflex Medical
II Dec-15-2015
2
Teleflex Medical
II Apr-30-2015
3
Teleflex Medical
II Feb-12-2015
4
Teleflex Medical
II Jul-23-2014
5
Teleflex Medical
II Jul-07-2014
6
Vapotherm, Inc.
II Sep-25-2014
7
Vyaire Medical
I Jan-24-2018
TPLC Last Update: 2019-04-02 19:27:03

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