Ventilator, Non-continuous (respirator)

Device Code: 66

Product Code(s): BZD

Device Classification Information

Device Type ID66
Device NameVentilator, Non-continuous (respirator)
Regulation DescriptionNoncontinuous Ventilator (IPPB).
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 Number868.5905 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeBZD
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID66
DeviceVentilator, Non-continuous (respirator)
Product CodeBZD
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionNoncontinuous Ventilator (IPPB).
CFR Regulation Number868.5905 [🔎]
Premarket Reviews
ManufacturerDecision
3B MEDICAL, INC
 
SUBSTANTIALLY EQUIVALENT
 2
APEX MEDICAL CORP.
 
SUBSTANTIALLY EQUIVALENT
 2
BMC MEDICAL CO., LTD
 
SUBSTANTIALLY EQUIVALENT
 1
CURATIVE MEDICAL TECHNOLOGY LTD.
 
SUBSTANTIALLY EQUIVALENT
 1
DEVILBISS HEALTHCARE LLC
 
SUBSTANTIALLY EQUIVALENT
 1
FISHER & PAYKEL HEALTHCARE LIMITED
 
SUBSTANTIALLY EQUIVALENT
 1
FISHER & PAYKEL HEALTHCARE LTD
 
SUBSTANTIALLY EQUIVALENT
 1
FISHER & PAYKEL HEALTHCARE LTD.
 
SUBSTANTIALLY EQUIVALENT
 3
HUMAN DESIGN MEDICAL LLC
 
SUBSTANTIALLY EQUIVALENT
 1
PHILIPS MEDICAL SYSTEMS INTERNATIONAL BV
 
SUBSTANTIALLY EQUIVALENT
 7
RESMED
 
SUBSTANTIALLY EQUIVALENT
 7
RESMED CORP
 
SUBSTANTIALLY EQUIVALENT
 1
RESMED CORP.
 
SUBSTANTIALLY EQUIVALENT
 6
RESMED LTD
 
SUBSTANTIALLY EQUIVALENT
 8
RESPIRONICS, INC.
 
SUBSTANTIALLY EQUIVALENT
 8
SALTER LABS
 
SUBSTANTIALLY EQUIVALENT
 1
SKY WISE MEDICAL INSTRUMENT (SHEN ZHEN) CO., LTD.
 
SUBSTANTIALLY EQUIVALENT
 1
SMD MANUFACTURING, LLC
 
SUBSTANTIALLY EQUIVALENT
 1
SOMNETICS INTERNATIONAL, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
STEVENSON INDUSTRIES, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
Device Problems
Fire
 50
Device Operates Differently Than Expected
 47
Adverse Event Without Identified Device Or Use Problem
 37
Device Issue
 30
Thermal Decomposition Of Device
 19
Insufficient Information
 16
No Display / Image
 14
Solder Joint Fracture
11
Device Markings / Labelling Problem
 10
Appropriate Term/Code Not Available
 9
Device Displays Incorrect Message
9
Use Of Device Problem
 8
Mechanical Problem
 8
No Audible Alarm
 7
Electrical /Electronic Property Problem
 7
Device Inoperable
 7
Connection Problem
 6
Disconnection
 6
Pressure Problem
 5
Device Stops Intermittently
 5
Device Operational Issue
 5
Temperature Problem
 4
Difficult To Position
 3
Inaccurate Delivery
3
Partial Blockage
 3
Human-Device Interface Problem
 3
Contamination During Use
 3
Corroded
3
Misconnection
 2
Material Integrity Problem
 2
Power Problem
 2
Fracture
 2
Contamination / Decontamination Problem
2
Physical Property Issue
 2
Failure To Calibrate
 2
Fitting Problem
 2
Arcing
 2
Unintended Movement
 2
Device Handling Problem
 2
Hole In Material
 2
Cut In Material
 2
Detachment Of Device Or Device Component
 2
Overheating Of Device
 2
Crack
 2
Display Or Visual Feedback Problem
 2
Loose Or Intermittent Connection
 2
Moisture Or Humidity Problem
 2
Low Battery
 1
Electrical Overstress
 1
Improper Flow Or Infusion
 1
Inadequate User Interface
 1
Torn Material
 1
Missing Value Reason
 1
Break
 1
Loss Of Power
 1
Failure To Power Up
 1
Material Separation
 1
Telemetry Discrepancy
 1
Patient Device Interaction Problem
 1
Unexpected Shutdown
 1
Fumes Or Vapors
 1
Human Factors Issue
 1
Electromagnetic Interference
 1
Power Cord
 1
Leak / Splash
 1
Inadequacy Of Device Shape And/or Size
 1
Deformation Due To Compressive Stress
1
Maintenance Does Not Comply To Manufacturers Recommendations
 1
Loss Of Or Failure To Bond
 1
Failure To Charge
 1
Power Supply
 1
Cord
 1
Failure To Deliver
 1
Obstruction Of Flow
 1
Melted
 1
Circuit Failure
 1
Communication Or Transmission Problem
 1
Device Reprocessing Problem
 1
Failure To Cycle
 1
Material Disintegration
 1
Improper Or Incorrect Procedure Or Method
 1
Defective Component
 1
Product Quality Problem
 1
Inaccurate Flow Rate
 1
Battery Problem
 1
Device Sensing Problem
 1
Facilities Issue
 1
Flare Or Flash
 1
Total Device Problems 417
Recalls
Manufacturer Recall Class Date Posted
1
Beevers Manufacturing & Supply, Inc.
 II Dec-02-2014
2
Beevers Manufacturing & Supply, Inc.
 II Dec-01-2014
3
Compass Health Brands (Corporate Office)
 I Aug-20-2018
4
DeVilbiss Healthcare LLC
 III Jul-01-2014
5
Resmed Corporation
 II Aug-16-2016
TPLC Last Update: 2019-04-02 19:27:44
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.