Ventilator, Emergency, Manual (resuscitator)

Device Code: 20

Product Code(s): BTM

Device Classification Information

• Device Type ID: 20
• Device Name: Ventilator, Emergency, Manual (resuscitator)
• Regulation Description: Manual 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: 868.5915 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: BTM
• 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
• 1-73 ISO 10651-4 First Edition 2002-03-01
  Lung Ventilators - Part 4: Particular Requirements For Operator Powered Resuscitators
• 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
• 1-136 ISO 18562-3 First Edition 2017-03
  Biocompatibility Evaluation Of Breathing Gas Pathways In Healthcare Applications - Part 3: Tests For Emissions Of Volatile Organic Compounds
• 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: 20
• Device: Ventilator, Emergency, Manual (resuscitator)
• Product Code: BTM
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Manual Emergency Ventilator.
• CFR Regulation Number: 868.5915 [🔎]

Premarket Reviews
Manufacturer	Decision
AMBU A/S
	SUBSTANTIALLY EQUIVALENT	1
AMBU INTERNATIONAL A/S
	SUBSTANTIALLY EQUIVALENT	1
FOREMOUNT ENTERPRISE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
LAERDAL MEDICAL A/S
	SUBSTANTIALLY EQUIVALENT	1
LAERDAL MEDICAL CORP.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
No Flow	70
Failure To Deliver	68
Valve, Inhalation	49
Device Issue	31
Separation Failure	20
Device Operational Issue	19
Device Damaged Prior To Use	16
Device Operates Differently Than Expected	15
Appropriate Term/Code Not Available	13
Defective Component	10
Inflation Problem	9
Missing Value Reason	8
Activation, Positioning Or Separation Problem	5
Use Of Device Problem	4
Insufficient Information	4
Loose Or Intermittent Connection	4
Air Leak	4
Device Handling Problem	3
Leak / Splash	3
Fitting Problem	3
Material Deformation	3
Mechanical Problem	3
Collapse	3
Device Dislodged Or Dislocated	3
Connection Problem	3
Adverse Event Without Identified Device Or Use Problem	3
Product Quality Problem	3
Component Missing	2
Torn Material	2
Imprecision	2
Manufacturing, Packaging Or Shipping Problem	2
Thermal Decomposition Of Device	1
Restricted Flow Rate	1
Break	1
Crack	1
Blocked Connection	1
Delivery System Failure	1
Detachment Of Device Or Device Component	1
Improper Flow Or Infusion	1
Packaging Problem	1
Detachment Of Device Component	1
Patient Device Interaction Problem	1
Complete Blockage	1
Tube	1
Shipping Damage Or Problem	1
No Apparent Adverse Event	1
Material Split, Cut Or Torn	1
Misassembled	1
Decoupling	1
Improper Device Output	1
Energy Output To Patient Tissue Incorrect	1
Fire	1
Gas Leak	1
Total Device Problems	409

Recalls
Manufacturer		Recall Class	Date Posted
1	GE Healthcare	II	Feb-03-2014
2	GE Healthcare, LLC	I	Feb-25-2014
3	Sun Med, LLC	II	Jun-09-2018
4	Teleflex Medical	I	Jun-24-2015
5	Ventlab LLC	I	Jul-03-2014
6	Vyaire Medical	I	Aug-08-2018

TPLC Last Update: 2019-04-02 19:26:53