Ventilator, Emergency, Powered (resuscitator)

Device Code: 19

Product Code(s): BTL

Device Classification Information

• Device Type ID: 19
• Device Name: Ventilator, Emergency, Powered (resuscitator)
• Regulation Description: Powered Emergency Ventilator.
• Regulation Medical Specialty: Anesthesiology
• Review Panel: Anesthesiology
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID); Respiratory Devices Branch (RPDB)
• Submission Type: 510(k)
• CFR Regulation Number: 868.5925 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: BTL
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: Yes
• Third Party Review: Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

• 1-62 ISO 5356-1 Third Edition 2004-05-15
  Anaesthetic And Respiratory Equipment - Conical Connectors: Part 1: Cones And Sockets
• 1-72 ISO 10651-5 First Edition 2006-02-01
  Lung Ventilators For Medical Use - Particular Requirements For Basic Safety And Essential Performance - Part 5: Gas-powered Emergency Resuscitators
• 1-81 CGA V-5:2008 (Reaffirmed 2013)
  Diameter-Index Safety System (Noninterchangeable Low Pressure Connections For Medical Gas Applications)
• 1-134 ISO 18562-1 First Edition 2017-03
  Biocompatibility Evaluation Of Breathing Gas Pathways In Healthcare Applications - Part 1: Evaluation And Testing Within A Risk Management Process
• 1-135 ISO 18562-2 First Edition 2017-03
  Biocompatibility Evaluation Of Breathing Gas Pathways In Healthcare Applications - Part 2: Tests For Emissions Of Particulate Matter
• 1-137 ISO 18562-4 First Edition 2017-03
  Biocompatibility Evaluation Of Breathing Gas Pathways In Healthcare Applications - Part 4: Tests For Leachables In Condensate

Total Product Life Cycle

• Device Type ID: 19
• Device: Ventilator, Emergency, Powered (resuscitator)
• Product Code: BTL
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Powered Emergency Ventilator.
• CFR Regulation Number: 868.5925 [🔎]

Premarket Reviews
Manufacturer	Decision
ALLIED HEALTHCARE PRODUCTS, INC.
	SUBSTANTIALLY EQUIVALENT	2
AUTOMEDX INC.
	SUBSTANTIALLY EQUIVALENT	1
DOLPHYS MEDICAL B.V.
	SUBSTANTIALLY EQUIVALENT	1
INTERNATIONAL BIOMEDICAL
	SUBSTANTIALLY EQUIVALENT	2
INTERNATIONAL BIOMEDICAL, LTD.
	SUBSTANTIALLY EQUIVALENT	2
MERCURY ENTERPRISES, INC.
	SUBSTANTIALLY EQUIVALENT	1
MERCURY MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
O-TWO MEDICAL TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
THORNHILL RESEARCH INC
	SUBSTANTIALLY EQUIVALENT	1
THORNHILL RESEARCH INCORPORATED
	SUBSTANTIALLY EQUIVALENT	1
VENTLAB, LLC
	SUBSTANTIALLY EQUIVALENT	1
VORTRAN MEDICAL TECHNOLOGY 1, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Break	80
Device Issue	75
Device Handling Problem	28
Pressure Problem	25
Tidal Volume Fluctuations	23
Defective Component	19
Infusion Or Flow Problem	17
Device Operates Differently Than Expected	16
Output Problem	16
Noise, Audible	13
Device Alarm System	12
Component Missing	12
Physical Property Issue	10
Knob	10
Device Maintenance Issue	10
Crack	8
Valve, Flow	7
Defective Alarm	7
Device Operational Issue	7
Failure To Cycle	6
Use Of Device Problem	6
No Flow	6
Failure To Deliver	6
No Audible Alarm	6
Increase In Pressure	6
Mechanical Problem	6
Alarm	5
Loose Or Intermittent Connection	5
Free Or Unrestricted Flow	5
Leak / Splash	5
Physical Resistance / Sticking	5
Gauges/Meters	5
Connection Problem	5
No Apparent Adverse Event	4
Gas Leak	4
Battery Problem	4
Power Problem	4
No Pressure	4
Cover	4
Decrease In Pressure	4
Device Damaged Prior To Use	4
Insufficient Information	4
Failure To Align	3
Detachment Of Device Component	3
Device Contamination With Chemical Or Other Material	3
Gas Delivery System	3
Loss Of Power	3
Material Twisted / Bent	3
Device Component Or Accessory	3
Gas Output Problem	3
Circuit Failure	3
Electrical /Electronic Property Problem	3
Inappropriate Or Unexpected Reset	2
Adverse Event Without Identified Device Or Use Problem	2
Device Displays Incorrect Message	2
Failure To Charge	2
Inflation Problem	2
Device Fell	2
Charging Problem	2
Valve	2
Device Stops Intermittently	2
Device Inoperable	2
Mechanical Jam	2
Intermittent Loss Of Power	2
Tube	2
False Device Output	2
Unintended Movement	2
Failure Of Device To Self-Test	2
Defective Device	2
Inaccurate Delivery	2
Improper Flow Or Infusion	2
Insufficient Flow Or Under Infusion	2
No Audible Prompt / Feedback	2
Valve, Inlet Port	2
Disconnection	2
Emergency Power Failure	1
Computer Software Problem	1
Speaker	1
Alarm, Audible	1
Alarm, Pressure	1
Unable To Obtain Readings	1
Delayed Charge Time	1
Device Markings / Labelling Problem	1
Mechanics Altered	1
No Device Output	1
Incorrect, Inadequate Or Imprecise Result Or Readings	1
Separation Problem	1
Needle	1
Calibration Problem	1
Detachment Of Device Or Device Component	1
Failure To Shut Off	1
Low Audible Alarm	1
Labelling, Instructions For Use Or Training Problem	1
Control Switches	1
Improper Alarm	1
Fail-Safe Design Failure	1
Image Display Error / Artifact	1
Dent In Material	1
Device Misassembled During Manufacturing / Shipping	1
Incomplete Or Inadequate Connection	1
Total Device Problems	609

Recalls
Manufacturer		Recall Class	Date Posted
1	Draeger Medical Systems, Inc.	I	Apr-10-2014
2	GE Healthcare	II	Feb-03-2014
3	GE Healthcare, LLC	I	Feb-25-2014
4	Impact Instrumentation, Inc.	II	Jun-26-2015
5	Mercury Enterprises, Inc. Dba Mercury Medical	II	Jan-12-2016
6	Thornhill Research Inc	I	Jan-11-2016
7	Vortran Medical Technology 1, Inc	II	Apr-25-2017

TPLC Last Update: 2019-04-02 19:26:52