Ventilator, Continuous, Facility Use

Device Code: 100

Product Code(s): CBK

Device Classification Information

• Device Type ID: 100
• Device Name: Ventilator, Continuous, Facility Use
• Regulation Description: Continuous 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: 868.5895 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: CBK
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: Yes
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 1-62 ISO 5356-1 Third Edition 2004-05-15
  Anaesthetic And Respiratory Equipment - Conical Connectors: Part 1: Cones And Sockets
• 1-98 ISO 80601-2-12 First Edition 2011-04-15
  Medical Electrical Equipment - Part 2-12: Particular Requirements For The Safety Of Lung Ventilators - Critical Care Ventilators [Including: Technical Corrigendum 1 (2011)]
• 1-129 ISO 5359 Fourth Edition 2014-10-01
  Anaesthetic And Respiratory Equipment - Low-pressure Hose Assemblies For Use With Medical Gases [Including AMENDMENT 1 (2017)]
• 1-130 ISO 18082 First Edition 2014-06-15
  Anaesthetic And Respiratory Equipment - Dimensions Of Noninterchangeable Screw-threaded (NIST) Low-pressure Connectors For Medical Gases [Including AMENDMENT 1 (2017)]
• 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
• 1-138 ISO 80601-2-74 First Edition 2017-05
  Medical Electrical Equipment - Part 2-74: Particular Requirements For Basic Safety And Essential Performance Of Respiratory Humidifying Equipment

Total Product Life Cycle

• Device Type ID: 100
• Device: Ventilator, Continuous, Facility Use
• Product Code: CBK
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Continuous Ventilator.
• CFR Regulation Number: 868.5895 [🔎]

Premarket Reviews
Manufacturer	Decision
BIO-MED
	SUBSTANTIALLY EQUIVALENT	1
BIO-MED DEVICES, INC.
	SUBSTANTIALLY EQUIVALENT	1
BREATHE TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	2
COVIDIEN
	SUBSTANTIALLY EQUIVALENT	3
COVIDIEN LP
	SUBSTANTIALLY EQUIVALENT	1
DATEX-OHMEDA, INC.
	SUBSTANTIALLY EQUIVALENT	2
DRAEGER MEDICAL GMBH
	SUBSTANTIALLY EQUIVALENT	1
DRAGERWERK AG & CO. KGAA
	SUBSTANTIALLY EQUIVALENT	1
FLIGHT MEDICAL INNOVATIONS
	SUBSTANTIALLY EQUIVALENT	2
HAMILTON
	SUBSTANTIALLY EQUIVALENT	3
HAMILTON MEDICAL AG
	SUBSTANTIALLY EQUIVALENT	3
IMTMEDICAL AG
	SUBSTANTIALLY EQUIVALENT	1
MAQUET CRITICAL CARE AB
	SUBSTANTIALLY EQUIVALENT	3
MAQUET, INC.
	SUBSTANTIALLY EQUIVALENT	3
PHILIPS MEDICAL SYSTEMS INTERNATIONAL BV
	SUBSTANTIALLY EQUIVALENT	1
RESMED
	SUBSTANTIALLY EQUIVALENT	3
RESMED CORP.
	SUBSTANTIALLY EQUIVALENT	3
RESMED LTD
	SUBSTANTIALLY EQUIVALENT	1
RESPIRONICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
ZOLL MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Device Displays Incorrect Message	6757
Device Operates Differently Than Expected	3014
Incorrect Or Inadequate Test Results	2516
Device Operational Issue	2342
Device Inoperable	2311
No Display / Image	2080
Failure To Charge	2072
Battery Problem	2049
Failure To Calibrate	1979
Appropriate Term/Code Not Available	1829
Mechanical Problem	784
Failure To Power Up	770
Circuit Failure	719
Power Problem	568
Failure To Recalibrate	527
Device Alarm System	442
Erratic Or Intermittent Display	398
Adverse Event Without Identified Device Or Use Problem	343
Charging Problem	343
Calibration Problem	298
No Flow	288
Electrical /Electronic Property Problem	279
Leak / Splash	262
Inaccurate Delivery	249
Failure To Deliver	229
Pressure Problem	210
Aborted Charge	208
Protective Measures Problem	205
Failure To Cycle	197
Device Stops Intermittently	186
Display Or Visual Feedback Problem	175
Output Problem	172
Break	169
No Audible Alarm	166
Tidal Volume Fluctuations	161
Self-Activation Or Keying	159
Noise, Audible	152
Volume Accuracy Problem	140
Insufficient Information	136
Loss Of Power	124
Occlusion Within Device	121
Contamination During Use	108
Communication Or Transmission Problem	103
Device Sensing Problem	102
Battery	90
Application Program Problem	88
Failure Of Device To Self-Test	86
Suction Problem	84
Infusion Or Flow Problem	83
Detachment Of Device Component	81
Connection Problem	80
Unexpected Shutdown	74
Improper Flow Or Infusion	72
Disconnection	69
Thermal Decomposition Of Device	69
Incorrect, Inadequate Or Imprecise Result Or Readings	68
Defective Alarm	67
Increase In Pressure	62
Inappropriate Or Unexpected Reset	58
Premature Discharge Of Battery	55
Screen	50
Decrease In Pressure	48
Failure To Run On AC/DC	44
Image Display Error / Artifact	41
Use Of Device Problem	40
Low Readings	37
Crack	37
Temperature Problem	37
No Pressure	35
Improper Alarm	34
Overheating Of Device	32
Smoking	31
Excess Flow Or Over-Infusion	29
Unintended Collision	28
Alarm Not Visible	28
Ventilation Problem In Device Environment	26
Valve	26
False Alarm	25
Defective Component	24
Fire	24
High Readings	24
Device Maintenance Issue	24
Air Leak	24
Mechanical Jam	23
Reset Problem	23
Calibration Error	22
Unexpected Therapeutic Results	22
Application Interface Becomes Non-Functional Or Program Exits Abnormally	22
Device Issue	21
Material Deformation	20
Gas Leak	20
Gas Output Problem	20
Loose Or Intermittent Connection	19
Alarm, Audible	18
Low Battery	18
Display	18
Material Integrity Problem	18
Sticking	17
Device Emits Odor	16
Human-Device Interface Problem	16
Total Device Problems	38709

Recalls
Manufacturer		Recall Class	Date Posted
1	COVIDIEN LLC	I	Dec-18-2018
2	CareFusion 203, Inc.	I	Sep-19-2014
3	Carefusion 211 Inc Dba Carefusion	I	Jun-13-2016
4	Carefusion 211 Inc Dba Carefusion	I	May-26-2015
5	Covidien	I	Jan-03-2014
6	Covidien LLC	II	Mar-27-2018
7	Covidien LP (formerly Nellcor Puritan Bennett Inc.)	II	Mar-17-2016
8	Covidien LP (formerly Nellcor Puritan Bennett Inc.)	I	Aug-14-2015
9	Covidien LP (formerly Nellcor Puritan Bennett Inc.)	II	Feb-05-2015
10	Datex-Ohmeda, Inc.	II	Aug-08-2018
11	Datex-Ohmeda, Inc.	II	Jun-01-2018
12	Del Mar Reynolds Medical, Ltd.	II	Mar-14-2017
13	Del Mar Reynolds Medical, Ltd.	II	Apr-20-2015
14	Del Mar Reynolds Medical, Ltd.	I	Apr-12-2014
15	Draeger Medical Systems, Inc.	I	Mar-28-2014
16	Draeger Medical, Inc.	II	May-29-2018
17	Draeger Medical, Inc.	I	Aug-04-2016
18	Draeger Medical, Inc.	I	Feb-25-2016
19	Draeger Medical, Inc.	I	Feb-03-2016
20	Draeger Medical, Inc.	I	Dec-23-2015
21	Draeger Medical, Inc.	I	Aug-14-2015
22	Event Medical LTD	I	Nov-19-2015
23	GE Healthcare	II	Mar-24-2015
24	GE Healthcare, LLC	I	Nov-30-2018
25	GE Medical Systems, LLC	II	Jan-21-2016
26	Hamilton Medical AG	II	Aug-14-2018
27	Hamilton Medical AG	II	Apr-12-2018
28	Hamilton Medical, Inc.	II	Nov-28-2016
29	Hamilton Medical, Inc.	II	May-09-2016
30	Hamilton Medical, Inc.	I	Nov-04-2015
31	Hamilton Medical, Inc.	II	Jul-10-2015
32	Nellcor Puritan Bennett Inc. (dba Covidien LP)	I	Dec-09-2014
33	Nellcor Puritan Bennett Inc. (dba Covidien LP)	I	Oct-28-2014
34	Nellcor Puritan Bennett Inc. (dba Covidien LP)	II	Jun-20-2014
35	Nellcor Puritan Bennett Inc. (dba Covidien LP)	II	Jun-17-2014
36	Nellcor Puritan Bennett Inc. (dba Covidien LP)	II	May-09-2014
37	Nellcor Puritan Bennett Inc. (dba Covidien LP)	II	Jan-24-2014
38	Newport Medical Instruments Inc	I	Apr-10-2017
39	Newport Medical Instruments Inc	I	Apr-14-2014
40	Philips Respironics	II	Mar-07-2016
41	Phillips Respironics, Inc.	I	Mar-06-2014
42	ResMed Ltd.	II	Jun-10-2015
43	Resmed Corporation	II	Feb-03-2016
44	Respironics California Inc	II	Dec-01-2014
45	Respironics California Inc	I	Oct-21-2014
46	Spacelabs Healthcare, Ltd.	I	Aug-10-2018
47	ZOLL Medical Corporation	II	Mar-01-2018

TPLC Last Update: 2019-04-02 19:29:04