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TPLC
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Device
ventilator, non-continuous (respirator)
Product Code
BZD
Regulation Number
868.5905
Device Class
2
Premarket Reviews
Manufacturer
Decision
3B MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
2
1. K201620
Luna® G3 BPAP 25A
2. K212263
Luna G3 BPAP System
APEX MEDICAL CORP.
SUBSTANTIALLY EQUIVALENT
2
BMC MEDICAL CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
FISHER & PAYKEL HEALTHCARE LTD
SUBSTANTIALLY EQUIVALENT
3
FISHER & PAYKEL HEALTHCARE LTD.
SUBSTANTIALLY EQUIVALENT
2
RESMED CORP
SUBSTANTIALLY EQUIVALENT
1
RESMED LTD
SUBSTANTIALLY EQUIVALENT
1
RESMED PTY LTD
SUBSTANTIALLY EQUIVALENT
1
RESMED PTY LTD (REGISTRATION NUMBER: 3004604967)
SUBSTANTIALLY EQUIVALENT
2
RESPIRONICS INC.
SUBSTANTIALLY EQUIVALENT
3
RESPIRONICS, INC.
SUBSTANTIALLY EQUIVALENT
4
SLEEPNET CORPORATION
SUBSTANTIALLY EQUIVALENT
3
SUZHOU YUYUE MEDICAL TECHNOLOGY CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
SYSMED (CHINA) CO., LTD
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
188
188
2020
126
126
2021
6062
6062
2022
90783
90783
2023
27997
27997
2024
13176
13176
Device Problems
MDRs with this Device Problem
Events in those MDRs
Degraded
132027
132027
Contamination
2714
2714
Corroded
2447
2447
Nonstandard Device
756
756
Patient-Device Incompatibility
385
385
Adverse Event Without Identified Device or Use Problem
364
364
Device Emits Odor
323
323
Overheating of Device
213
213
Smoking
211
211
Excessive Heating
155
155
Insufficient Information
154
154
Fire
152
152
Material Integrity Problem
147
147
Noise, Audible
147
147
Patient Device Interaction Problem
143
143
Contamination /Decontamination Problem
113
113
Particulates
105
105
Device Contamination with Chemical or Other Material
96
96
Failure to Power Up
92
92
Mechanical Problem
92
92
No Apparent Adverse Event
71
71
Break
58
58
Disconnection
57
57
Thermal Decomposition of Device
55
55
Product Quality Problem
52
52
Temperature Problem
47
47
Defective Device
46
46
Power Problem
42
42
Pressure Problem
41
41
Obstruction of Flow
38
38
Circuit Failure
37
37
Unexpected Shutdown
36
36
Complete Loss of Power
35
35
Use of Device Problem
32
32
Decrease in Pressure
31
31
Appropriate Term/Code Not Available
30
30
Sparking
30
30
Detachment of Device or Device Component
29
29
Therapeutic or Diagnostic Output Failure
28
28
Increase in Pressure
27
27
Electrical /Electronic Property Problem
27
27
Output Problem
26
26
Melted
25
25
Material Disintegration
23
23
Insufficient Heating
22
22
Leak/Splash
22
22
Loose or Intermittent Connection
21
21
Connection Problem
21
21
Material Split, Cut or Torn
18
18
Defective Component
18
18
Fitting Problem
16
16
Unintended Movement
16
16
Material Fragmentation
14
14
Intermittent Loss of Power
14
14
Crack
14
14
Calcified
14
14
Gas/Air Leak
13
13
Material Discolored
13
13
Unraveled Material
13
13
Material Erosion
13
13
Moisture or Humidity Problem
12
12
Material Separation
12
12
Computer Software Problem
11
11
Component Missing
11
11
Improper or Incorrect Procedure or Method
10
10
Scratched Material
10
10
Insufficient Flow or Under Infusion
10
10
Manufacturing, Packaging or Shipping Problem
10
10
Fluid/Blood Leak
10
10
Improper Flow or Infusion
10
10
Display or Visual Feedback Problem
9
9
Material Deformation
9
9
Chemical Problem
9
9
Flare or Flash
8
8
Unexpected Therapeutic Results
8
8
Unintended Electrical Shock
8
8
No Pressure
8
8
Use of Incorrect Control/Treatment Settings
8
8
Device Markings/Labelling Problem
7
7
Infusion or Flow Problem
7
7
Failure to Deliver
7
7
No Display/Image
7
7
Device Displays Incorrect Message
6
6
Compatibility Problem
6
6
Complete Blockage
6
6
Electromagnetic Interference
6
6
Excess Flow or Over-Infusion
5
5
Device-Device Incompatibility
5
5
Physical Resistance/Sticking
5
5
Contamination of Device Ingredient or Reagent
5
5
Fungus in Device Environment
5
5
Microbial Contamination of Device
5
5
Device Slipped
5
5
Data Problem
5
5
Human-Device Interface Problem
4
4
Structural Problem
4
4
Incorrect, Inadequate or Imprecise Result or Readings
4
4
Failure to Shut Off
4
4
Electrical Overstress
4
4
Inadequate Instructions for Non-Healthcare Professional
4
4
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
91199
91199
Headache
12619
12619
Dyspnea
11324
11324
Unspecified Respiratory Problem
10910
10910
Respiratory Tract Infection
7959
7959
Sore Throat
7912
7912
Cough
7012
7012
Dizziness
5577
5577
Cancer
4667
4667
Asthma
3063
3063
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2471
2471
Nausea
2321
2321
Unspecified Kidney or Urinary Problem
1912
1912
Skin Inflammation/ Irritation
1779
1779
Dry Mouth
1774
1774
Chest Pain
1380
1380
Unspecified Heart Problem
1261
1261
Insufficient Information
1167
1167
Sleep Dysfunction
1087
1087
Inflammation
1084
1084
Vomiting
1061
1061
Hypersensitivity/Allergic reaction
1057
1057
Epistaxis
1012
1012
Fatigue
888
888
Chronic Obstructive Pulmonary Disease (COPD)
695
695
Pneumonia
694
694
Nodule
642
642
Dry Eye(s)
584
584
Unspecified Eye / Vision Problem
508
508
Pain
505
505
Heart Failure/Congestive Heart Failure
450
450
Apnea
445
445
Bronchitis
415
415
Sneezing
415
415
Unspecified Hepatic or Biliary Problem
394
394
Burning Sensation
359
359
High Blood Pressure/ Hypertension
335
335
Liver Damage/Dysfunction
325
325
Stroke/CVA
325
325
Swelling/ Edema
320
320
Nasal Obstruction
301
301
Choking
300
300
Rash
292
292
Wheezing
250
250
Anxiety
231
231
Unspecified Infection
225
225
Pulmonary Dysfunction
205
205
Unspecified Ear or Labyrinth Problem
191
191
Hemoptysis
173
173
Breast Cancer
173
173
Unspecified Gastrointestinal Problem
159
159
Atrial Fibrillation
158
158
Memory Loss/Impairment
152
152
Low Oxygen Saturation
150
150
Respiratory Failure
149
149
Cardiac Arrest
148
148
Pharyngitis
146
146
Excessive Tear Production
144
144
Eye Infections
139
139
Renal Failure
132
132
Eye Pain
128
128
Red Eye(s)
126
126
Itching Sensation
123
123
Solid Tumour
123
123
Fibrosis
122
122
Speech Disorder
121
121
Lymphoma
113
113
Arrhythmia
106
106
Myocardial Infarction
100
100
Convulsion/Seizure
93
93
Taste Disorder
92
92
Renal Impairment
91
91
Cardiovascular Insufficiency
90
90
Vertigo
87
87
Ulcer
83
83
Pulmonary Embolism
81
81
Sinus Perforation
80
80
Fluid Discharge
79
79
Unspecified Blood or Lymphatic problem
79
79
Angina
79
79
Eye Burn
76
76
No Consequences Or Impact To Patient
75
75
Aspiration/Inhalation
74
74
Discomfort
74
74
Hemorrhage/Bleeding
74
74
Bacterial Infection
74
74
Pulmonary Emphysema
70
70
Abdominal Pain
70
70
Pulmonary Hypertension
69
69
Weight Changes
69
69
Swollen Lymph Nodes/Glands
67
67
Cyst(s)
65
65
Embolism/Embolus
62
62
Blurred Vision
61
61
Hypoxia
60
60
Fever
59
59
No Known Impact Or Consequence To Patient
59
59
Numbness
58
58
Pulmonary Edema
58
58
Respiratory Insufficiency
58
58
Recalls
Manufacturer
Recall Class
Date Posted
1
Draeger Medical, Inc.
I
May-17-2023
2
Galemed Corporation
I
Dec-20-2019
3
Philips Respironics, Inc.
I
Apr-06-2023
4
Philips Respironics, Inc.
I
Sep-30-2022
5
Philips Respironics, Inc.
I
Jul-13-2021
6
ResMed Ltd.
I
Dec-21-2023
7
SleepNet Corporation
I
Apr-01-2024
8
TELEFLEX-MORRISVILLE
I
Nov-07-2019
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