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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
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
27995
27995
2024
8574
8574
Device Problems
MDRs with this Device Problem
Events in those MDRs
Degraded
127612
127612
Contamination
2657
2657
Corroded
2444
2444
Nonstandard Device
756
756
Patient-Device Incompatibility
385
385
Adverse Event Without Identified Device or Use Problem
339
339
Device Emits Odor
316
316
Overheating of Device
198
198
Smoking
193
193
Excessive Heating
151
151
Noise, Audible
145
145
Fire
144
144
Patient Device Interaction Problem
142
142
Insufficient Information
136
136
Material Integrity Problem
134
134
Contamination /Decontamination Problem
112
112
Particulates
105
105
Device Contamination with Chemical or Other Material
95
95
Failure to Power Up
88
88
Mechanical Problem
88
88
No Apparent Adverse Event
63
63
Break
58
58
Disconnection
56
56
Thermal Decomposition of Device
54
54
Product Quality Problem
52
52
Defective Device
46
46
Temperature Problem
45
45
Power Problem
42
42
Pressure Problem
41
41
Obstruction of Flow
36
36
Circuit Failure
36
36
Complete Loss of Power
35
35
Unexpected Shutdown
34
34
Use of Device Problem
31
31
Sparking
30
30
Decrease in Pressure
29
29
Therapeutic or Diagnostic Output Failure
28
28
Appropriate Term/Code Not Available
28
28
Increase in Pressure
27
27
Detachment of Device or Device Component
26
26
Output Problem
26
26
Melted
24
24
Electrical /Electronic Property Problem
24
24
Leak/Splash
22
22
Loose or Intermittent Connection
21
21
Insufficient Heating
21
21
Material Disintegration
21
21
Connection Problem
21
21
Defective Component
18
18
Material Split, Cut or Torn
17
17
Unintended Movement
16
16
Fitting Problem
16
16
Material Fragmentation
14
14
Crack
13
13
Material Erosion
13
13
Material Discolored
13
13
Calcified
13
13
Intermittent Loss of Power
13
13
Material Separation
12
12
Gas/Air Leak
12
12
Moisture or Humidity Problem
12
12
Unraveled Material
11
11
Component Missing
11
11
Computer Software Problem
11
11
Fluid/Blood Leak
10
10
Improper or Incorrect Procedure or Method
10
10
Insufficient Flow or Under Infusion
10
10
Manufacturing, Packaging or Shipping Problem
10
10
Material Deformation
9
9
Improper Flow or Infusion
9
9
Chemical Problem
9
9
Display or Visual Feedback Problem
9
9
Scratched Material
9
9
No Pressure
8
8
Unintended Electrical Shock
8
8
Use of Incorrect Control/Treatment Settings
8
8
Flare or Flash
8
8
Unexpected Therapeutic Results
8
8
Device Markings/Labelling Problem
7
7
Compatibility Problem
6
6
Infusion or Flow Problem
6
6
Failure to Deliver
6
6
Device Displays Incorrect Message
6
6
Complete Blockage
6
6
Electromagnetic Interference
6
6
No Display/Image
5
5
Excess Flow or Over-Infusion
5
5
Fungus in Device Environment
5
5
Microbial Contamination of Device
5
5
Device Slipped
5
5
Contamination of Device Ingredient or Reagent
5
5
Device-Device Incompatibility
5
5
Physical Resistance/Sticking
5
5
Data Problem
5
5
Electrical Overstress
4
4
Failure to Shut Off
4
4
Inadequate Instructions for Non-Healthcare Professional
4
4
Human-Device Interface Problem
4
4
Structural Problem
4
4
Off-Label Use
4
4
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
89807
89807
Headache
11613
11613
Dyspnea
11243
11243
Unspecified Respiratory Problem
8923
8923
Sore Throat
7878
7878
Respiratory Tract Infection
7593
7593
Cough
6938
6938
Dizziness
4592
4592
Cancer
3833
3833
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2312
2312
Asthma
2299
2299
Nausea
1965
1965
Dry Mouth
1750
1750
Chest Pain
1367
1367
Skin Inflammation/ Irritation
1362
1362
Unspecified Kidney or Urinary Problem
1351
1351
Insufficient Information
1131
1131
Sleep Dysfunction
1055
1055
Unspecified Heart Problem
1025
1025
Epistaxis
1004
1004
Fatigue
878
878
Inflammation
762
762
Hypersensitivity/Allergic reaction
746
746
Vomiting
727
727
Pneumonia
639
639
Nodule
624
624
Chronic Obstructive Pulmonary Disease (COPD)
610
610
Dry Eye(s)
583
583
Pain
500
500
Unspecified Eye / Vision Problem
497
497
Apnea
440
440
Sneezing
410
410
Heart Failure/Congestive Heart Failure
407
407
Bronchitis
375
375
Burning Sensation
355
355
High Blood Pressure/ Hypertension
328
328
Swelling/ Edema
317
317
Stroke/CVA
313
313
Choking
297
297
Rash
290
290
Nasal Obstruction
266
266
Unspecified Hepatic or Biliary Problem
244
244
Wheezing
243
243
Liver Damage/Dysfunction
240
240
Anxiety
227
227
Unspecified Infection
223
223
Unspecified Ear or Labyrinth Problem
189
189
Pulmonary Dysfunction
175
175
Hemoptysis
172
172
Breast Cancer
158
158
Atrial Fibrillation
152
152
Memory Loss/Impairment
150
150
Unspecified Gastrointestinal Problem
148
148
Low Oxygen Saturation
146
146
Cardiac Arrest
145
145
Excessive Tear Production
144
144
Pharyngitis
142
142
Eye Infections
139
139
Respiratory Failure
130
130
Eye Pain
127
127
Red Eye(s)
126
126
Renal Failure
126
126
Itching Sensation
123
123
Speech Disorder
121
121
Solid Tumour
119
119
Fibrosis
117
117
Lymphoma
104
104
Arrhythmia
101
101
Myocardial Infarction
95
95
Convulsion/Seizure
91
91
Taste Disorder
91
91
Renal Impairment
88
88
Vertigo
86
86
Ulcer
82
82
Fluid Discharge
79
79
Sinus Perforation
78
78
Angina
78
78
Pulmonary Embolism
77
77
No Consequences Or Impact To Patient
75
75
Eye Burn
75
75
Discomfort
74
74
Bacterial Infection
74
74
Unspecified Blood or Lymphatic problem
72
72
Cardiovascular Insufficiency
71
71
Hemorrhage/Bleeding
70
70
Aspiration/Inhalation
69
69
Abdominal Pain
68
68
Weight Changes
67
67
Pulmonary Emphysema
66
66
Swollen Lymph Nodes/Glands
65
65
Pulmonary Hypertension
65
65
Cyst(s)
62
62
Blurred Vision
61
61
No Known Impact Or Consequence To Patient
59
59
Embolism/Embolus
59
59
Fever
58
58
Hypoxia
57
57
Respiratory Insufficiency
57
57
Numbness
56
56
Malaise
55
55
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
TELEFLEX-MORRISVILLE
I
Nov-07-2019
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