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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
FISHER AND PAYKEL HEALTHCARE LIMITED
SUBSTANTIALLY EQUIVALENT
1
PHILIPS RESPIRONICS
SUBSTANTIALLY EQUIVALENT
1
REMSLEEP HOLDINGS
SUBSTANTIALLY EQUIVALENT
1
RESMED CORP
SUBSTANTIALLY EQUIVALENT
3
RESMED LTD
SUBSTANTIALLY EQUIVALENT
1
RESMED PTY LTD
SUBSTANTIALLY EQUIVALENT
1
RESMED PTY LTD (REGISTRATION NUMBER: 3004604967)
SUBSTANTIALLY EQUIVALENT
3
RESPIRONICS INC.
SUBSTANTIALLY EQUIVALENT
3
RESPIRONICS, INC.
SUBSTANTIALLY EQUIVALENT
4
SLEEPNET CORPORATION
SUBSTANTIALLY EQUIVALENT
5
1. K190254
Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face
...
2. K203601
Innova Nasal Non-Vented Mask
3. K211274
iQ 2 Nasal Mask, Phantom 2 Nasal Mask
4. K241469
iQ 2 Nasal Vented Mask; Phantom 2 Nasal Vented Mas
...
5. K241661
Mojo 2 Full Face Vented Mask; Veraseal 3 Full Face
...
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
51901
51901
Device Problems
MDRs with this Device Problem
Events in those MDRs
Degraded
169483
169483
Contamination
3890
3890
Corroded
2461
2461
Adverse Event Without Identified Device or Use Problem
1084
1084
Nonstandard Device
759
759
Patient-Device Incompatibility
390
390
Device Emits Odor
369
369
Smoking
253
253
Insufficient Information
248
248
Material Integrity Problem
242
242
Overheating of Device
238
238
Fire
170
170
Noise, Audible
163
163
Excessive Heating
161
161
Patient Device Interaction Problem
149
149
Contamination /Decontamination Problem
129
129
Temperature Problem
116
116
Mechanical Problem
109
109
Particulates
108
108
Failure to Power Up
104
104
Device Contamination with Chemical or Other Material
101
101
No Apparent Adverse Event
100
100
Thermal Decomposition of Device
68
68
Break
62
62
Disconnection
57
57
Product Quality Problem
52
52
Defective Device
46
46
Unexpected Shutdown
44
44
Power Problem
43
43
Activation Problem
42
42
Pressure Problem
41
41
Obstruction of Flow
40
40
Circuit Failure
39
39
Peeled/Delaminated
37
37
Decrease in Pressure
35
35
Appropriate Term/Code Not Available
35
35
Complete Loss of Power
35
35
Sparking
34
34
Detachment of Device or Device Component
32
32
Use of Device Problem
32
32
Electrical /Electronic Property Problem
32
32
Increase in Pressure
30
30
Unraveled Material
30
30
Leak/Splash
29
29
Therapeutic or Diagnostic Output Failure
28
28
Output Problem
26
26
Melted
26
26
Material Disintegration
25
25
Crack
23
23
Insufficient Heating
23
23
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
98688
98688
Unspecified Respiratory Problem
26487
26487
Headache
21867
21867
Dizziness
14783
14783
Cancer
13502
13502
Dyspnea
12087
12087
Asthma
12001
12001
Respiratory Tract Infection
9585
9585
Sore Throat
8120
8120
Unspecified Kidney or Urinary Problem
7771
7771
Cough
7635
7635
Skin Inflammation/ Irritation
5440
5440
Nausea
5222
5222
Inflammation
4786
4786
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
3917
3917
Vomiting
3886
3886
Hypersensitivity/Allergic reaction
3630
3630
Unspecified Heart Problem
3413
3413
Unspecified Hepatic or Biliary Problem
2034
2034
Dry Mouth
1901
1901
Insufficient Information
1834
1834
Chronic Obstructive Pulmonary Disease (COPD)
1711
1711
Chest Pain
1529
1529
Pneumonia
1193
1193
Sleep Dysfunction
1164
1164
Epistaxis
1073
1073
Heart Failure/Congestive Heart Failure
1034
1034
Fatigue
984
984
Liver Damage/Dysfunction
966
966
Bronchitis
825
825
Nodule
811
811
Dry Eye(s)
598
598
Unspecified Eye / Vision Problem
546
546
Pain
539
539
Stroke/CVA
488
488
Pulmonary Dysfunction
485
485
Apnea
470
470
High Blood Pressure/ Hypertension
459
459
Respiratory Failure
453
453
Sneezing
432
432
Burning Sensation
374
374
Breast Cancer
365
365
Cardiovascular Insufficiency
345
345
Swelling/ Edema
345
345
Nasal Obstruction
331
331
Lymphoma
326
326
Choking
324
324
Rash
306
306
Wheezing
294
294
Anxiety
262
262
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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