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Device
ventilator, continuous, facility use
Regulation Description
Continuous ventilator.
Product Code
CBK
Regulation Number
868.5895
Device Class
2
Premarket Reviews
Manufacturer
Decision
BIO-MED
SUBSTANTIALLY EQUIVALENT
1
BIO-MED DEVICES, INC.
SUBSTANTIALLY EQUIVALENT
1
BREATHE TECHNOLOGIES
SUBSTANTIALLY EQUIVALENT
1
COVIDIEN
SUBSTANTIALLY EQUIVALENT
2
COVIDIEN LP
SUBSTANTIALLY EQUIVALENT
1
COVIDIEN, LLC
SUBSTANTIALLY EQUIVALENT
1
DRAGERWERK AG & CO. KGAA
SUBSTANTIALLY EQUIVALENT
1
FLIGHT MEDICAL INNOVATIONS
SUBSTANTIALLY EQUIVALENT
1
HAMILTON
SUBSTANTIALLY EQUIVALENT
6
HAMILTON MEDICAL AG
SUBSTANTIALLY EQUIVALENT
6
IMTMEDICAL AG
SUBSTANTIALLY EQUIVALENT
2
MAQUET CRITICAL CARE AB
SUBSTANTIALLY EQUIVALENT
1
MAQUET, INC.
SUBSTANTIALLY EQUIVALENT
1
PHILIPS MEDICAL SYSTEMS INTERNATIONAL BV
SUBSTANTIALLY EQUIVALENT
2
RESMED
SUBSTANTIALLY EQUIVALENT
1
RESMED CORP.
SUBSTANTIALLY EQUIVALENT
1
RESMED LTD
SUBSTANTIALLY EQUIVALENT
1
RESPIRONICS, INC.
SUBSTANTIALLY EQUIVALENT
2
SLEEPNET CORPORATION
SUBSTANTIALLY EQUIVALENT
1
ZOLL MEDICAL CORPORATION
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2016
16055
16055
2017
14451
14451
2018
9848
9848
2019
9099
9501
2020
11097
11097
2021
3398
3398
Device Problems
MDRs with this Device Problem
Events in those MDRs
Device Displays Incorrect Message
10063
10063
Device Operates Differently Than Expected
7171
7171
Mechanical Problem
5328
5328
No Display/Image
3940
3940
Device Inoperable
3697
3697
Battery Problem
3691
3725
Circuit Failure
3058
3058
Failure to Charge
2755
2771
Failure to Calibrate
2746
3012
Device Operational Issue
2311
2311
Failure to Recalibrate
2167
2167
Output Problem
1807
1807
Incorrect Or Inadequate Test Results
1637
1637
Failure to Power Up
1595
1595
Appropriate Term/Code Not Available
1247
1247
Protective Measures Problem
1219
1258
Failure of Device to Self-Test
1198
1198
Power Problem
972
1014
Device Alarm System
790
790
Display or Visual Feedback Problem
741
741
No Flow
712
712
Calibration Problem
703
703
Erratic or Intermittent Display
680
680
Loss of Power
662
662
Electrical /Electronic Property Problem
622
622
Leak/Splash
600
600
Adverse Event Without Identified Device or Use Problem
575
575
Pressure Problem
560
560
Insufficient Information
540
540
Failure to Deliver
530
530
Incorrect, Inadequate or Imprecise Resultor Readings
465
465
Unexpected Shutdown
459
459
Infusion or Flow Problem
454
454
Break
453
453
Tidal Volume Fluctuations
450
450
Therapeutic or Diagnostic Output Failure
431
431
Charging Problem
427
427
Improper Flow or Infusion
426
426
Thermal Decomposition of Device
394
394
Noise, Audible
378
378
Communication or Transmission Problem
368
368
Application Program Problem
347
347
Inaccurate Delivery
344
344
Defective Component
324
324
Gas Output Problem
316
316
Device Stops Intermittently
315
315
Contamination
295
295
Application Interface Becomes Non-Functional Or Program Exits Abnormally
267
267
Failure to Cycle
259
259
Inappropriate or Unexpected Reset
257
258
Defective Device
252
252
No Audible Alarm
250
250
Inadequate User Interface
237
241
Decrease in Pressure
234
234
Aborted Charge
204
204
Use of Device Problem
187
187
Volume Accuracy Problem
184
184
Self-Activation or Keying
180
180
Computer Operating System Problem
170
170
Reset Problem
157
157
Device Sensing Problem
149
149
Premature Discharge of Battery
148
148
No Pressure
147
147
Image Display Error/Artifact
145
145
Occlusion Within Device
145
145
Smoking
142
142
Disconnection
138
138
Temperature Problem
134
134
Gas Leak
126
126
Complete Loss of Power
125
125
Defective Alarm
122
122
Overheating of Device
114
114
Ventilation Problem in Device Environment
112
112
Computer Software Problem
106
106
Device Emits Odor
100
100
Operating System Becomes Nonfunctional
93
93
Increase in Pressure
91
91
Suction Problem
86
86
Poor Quality Image
85
85
Detachment of Device or Device Component
82
82
Contamination /Decontamination Problem
77
77
Low Readings
76
76
Connection Problem
70
70
Failure to Read Input Signal
65
65
Degraded
65
65
Air Leak
60
60
High Readings
59
59
Loose or Intermittent Connection
56
56
Crack
54
54
Fire
52
52
Failure To Run On AC/DC
50
50
Low Battery
50
50
Nonstandard Device
49
49
Obstruction of Flow
48
48
Failure to Run on Battery
47
47
Improper Device Output
46
46
Data Problem
46
46
Excess Flow or Over-Infusion
46
46
Sticking
45
45
Failure to Shut Off
44
44
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Patient Involvement
28556
28556
No Consequences Or Impact To Patient
20636
21037
No Known Impact Or Consequence To Patient
5851
5852
No Clinical Signs, Symptoms or Conditions
4188
4188
No Information
2595
2595
No Code Available
1098
1098
Death
565
565
Low Oxygen Saturation
527
528
Insufficient Information
227
227
Respiratory Distress
83
83
Cardiac Arrest
70
70
Bradycardia
52
52
Hypoxia
42
42
Cyanosis
39
39
Patient Problem/Medical Problem
38
38
Cardiopulmonary Arrest
36
36
Hypoventilation
31
31
Pneumothorax
31
31
Injury
29
29
Dyspnea
26
26
Low Blood Pressure/ Hypotension
22
22
Respiratory Failure
21
21
Loss of consciousness
16
16
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
15
15
Tachycardia
12
12
Apnea
12
12
Respiratory Acidosis
11
11
Burn(s)
11
11
Respiratory Arrest
9
9
Stacking Breaths
8
8
Unspecified Infection
6
6
Pneumonia
6
6
Urinary Retention
6
6
Increased Respiratory Rate
5
5
Hyperventilation
5
5
Pain
5
5
Perforation
5
5
High Blood Pressure/ Hypertension
4
4
Aspiration/Inhalation
4
4
Lethargy
4
4
Decreased Respiratory Rate
4
4
Coma
4
4
High Oxygen Saturation
4
4
Vomiting
4
4
Discomfort
4
4
Burning Sensation
3
3
Ventricular Fibrillation
3
3
Adult Respiratory Distress Syndrome
3
3
Ventricular Tachycardia
3
3
Sweating
3
3
Cognitive Changes
3
3
Neurological Deficit/Dysfunction
3
3
Therapeutic Effects, Unexpected
3
3
Septic Shock
2
2
Swelling
2
2
Crushing Injury
2
2
Pulmonary Emphysema
2
2
Encephalopathy
2
2
Partial thickness (Second Degree) Burn
2
2
Vascular Dissection
2
2
Multiple Organ Failure
2
2
Pressure Sores
2
2
Sedation
2
2
Extubate
2
2
Respiratory Alkalosis
2
2
Bruise/Contusion
2
2
Arrhythmia
2
2
Abnormal Blood Gases
2
2
Myocardial Infarction
2
2
Pulmonary Edema
2
2
Tissue Damage
2
2
Brain Injury
2
2
Complaint, Ill-Defined
2
2
Therapeutic Response, Increased
2
2
Anxiety
2
2
Distress
2
2
Premature Labor
2
2
Ventilator Dependent
2
2
Confusion/ Disorientation
2
2
Electric Shock
2
2
Foreign Body In Patient
2
2
Device Embedded In Tissue or Plaque
2
2
Nervous System Injury
1
1
Salivary Hypersecretion
1
1
Hydrocephalus
1
1
Loss Of Pulse
1
1
Chemical Exposure
1
1
Blood Loss
1
1
Diminished Pulse Pressure
1
1
Weight Changes
1
1
Overinflation of Lung
1
1
Reaction
1
1
Arthralgia
1
1
Diabetic Ketoacidosis
1
1
Inadequate Osseointegration
1
1
Convulsion, Clonic
1
1
Blurred Vision
1
1
Loss of Vision
1
1
Stroke/CVA
1
1
Chest Pain
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
COVIDIEN LLC
I
Dec-18-2018
2
Carefusion 211 Inc dba Carefusion
I
Jun-13-2016
3
Covidien LLC
II
Mar-27-2018
4
Covidien LP (formerly Nellcor Puritan Bennett Inc.)
II
Mar-17-2016
5
Covidien Llc
II
Nov-06-2020
6
Datex-Ohmeda, Inc.
II
Aug-08-2018
7
Datex-Ohmeda, Inc.
II
Jun-01-2018
8
Del Mar Reynolds Medical, Ltd.
II
Mar-14-2017
9
Draeger Medical, Inc.
II
May-29-2018
10
Draeger Medical, Inc.
I
Aug-04-2016
11
Draeger Medical, Inc.
I
Feb-25-2016
12
Draeger Medical, Inc.
I
Feb-03-2016
13
GE Healthcare, LLC
II
Aug-24-2020
14
GE Healthcare, LLC
II
Dec-17-2019
15
GE Healthcare, LLC
I
Nov-30-2018
16
GE Medical Systems, LLC
II
Jan-21-2016
17
Getinge Group Logistics America, LLC
II
Oct-09-2020
18
Hamilton Medical AG
I
Jul-11-2019
19
Hamilton Medical AG
II
Aug-14-2018
20
Hamilton Medical AG
II
Apr-12-2018
21
Hamilton Medical, Inc.
II
Nov-28-2016
22
Hamilton Medical, Inc.
II
May-09-2016
23
Hill-Rom Manufacturing, Inc.
II
Nov-24-2020
24
Newport Medical Instruments Inc
I
Apr-10-2017
25
Philips Respironics
II
Mar-07-2016
26
Philips Respironics, Inc.
I
Feb-15-2020
27
Resmed Corporation
II
Feb-03-2016
28
Spacelabs Healthcare, Ltd.
I
Aug-10-2018
29
Vyaire Medical
II
Mar-04-2020
30
ZOLL Medical Corporation
II
Mar-01-2018
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