Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Back to Search Results
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
SUZHOU YUYUE MEDICAL TECHNOLOGY CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
1. K203347
Sleep Apnea Breathing Therapy Mask: YF-01 Full Fac
...
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
47441
47441
Device Problems
MDRs with this Device Problem
Events in those MDRs
Degraded
165146
165146
Contamination
3610
3610
Corroded
2459
2459
Adverse Event Without Identified Device or Use Problem
1034
1034
Nonstandard Device
758
758
Patient-Device Incompatibility
390
390
Device Emits Odor
363
363
Smoking
247
247
Insufficient Information
244
244
Overheating of Device
234
234
Material Integrity Problem
228
228
Fire
167
167
Noise, Audible
162
162
Excessive Heating
161
161
Patient Device Interaction Problem
149
149
Contamination /Decontamination Problem
129
129
Particulates
108
108
Temperature Problem
107
107
Mechanical Problem
105
105
Device Contamination with Chemical or Other Material
100
100
Failure to Power Up
99
99
No Apparent Adverse Event
88
88
Thermal Decomposition of Device
62
62
Break
62
62
Disconnection
57
57
Product Quality Problem
52
52
Defective Device
46
46
Power Problem
43
43
Unexpected Shutdown
42
42
Pressure Problem
41
41
Circuit Failure
39
39
Obstruction of Flow
38
38
Peeled/Delaminated
37
37
Activation Problem
36
36
Complete Loss of Power
35
35
Decrease in Pressure
35
35
Appropriate Term/Code Not Available
34
34
Use of Device Problem
32
32
Detachment of Device or Device Component
32
32
Electrical /Electronic Property Problem
32
32
Sparking
31
31
Leak/Splash
29
29
Increase in Pressure
29
29
Therapeutic or Diagnostic Output Failure
28
28
Output Problem
26
26
Melted
26
26
Unraveled Material
25
25
Material Disintegration
24
24
Insufficient Heating
23
23
Connection Problem
22
22
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
97862
97862
Unspecified Respiratory Problem
24272
24272
Headache
20604
20604
Dizziness
13564
13564
Cancer
12582
12582
Dyspnea
11918
11918
Asthma
11249
11249
Respiratory Tract Infection
9409
9409
Sore Throat
8066
8066
Cough
7514
7514
Unspecified Kidney or Urinary Problem
7186
7186
Skin Inflammation/ Irritation
5005
5005
Nausea
4839
4839
Inflammation
4292
4292
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
3659
3659
Vomiting
3520
3520
Hypersensitivity/Allergic reaction
3329
3329
Unspecified Heart Problem
3104
3104
Dry Mouth
1880
1880
Unspecified Hepatic or Biliary Problem
1858
1858
Insufficient Information
1721
1721
Chronic Obstructive Pulmonary Disease (COPD)
1606
1606
Chest Pain
1503
1503
Sleep Dysfunction
1144
1144
Pneumonia
1087
1087
Epistaxis
1062
1062
Fatigue
960
960
Heart Failure/Congestive Heart Failure
954
954
Liver Damage/Dysfunction
917
917
Nodule
784
784
Bronchitis
758
758
Dry Eye(s)
594
594
Unspecified Eye / Vision Problem
535
535
Pain
533
533
Pulmonary Dysfunction
469
469
Apnea
466
466
Stroke/CVA
456
456
High Blood Pressure/ Hypertension
437
437
Sneezing
429
429
Respiratory Failure
380
380
Burning Sensation
372
372
Swelling/ Edema
343
343
Breast Cancer
337
337
Nasal Obstruction
328
328
Choking
319
319
Cardiovascular Insufficiency
315
315
Rash
303
303
Lymphoma
302
302
Wheezing
285
285
Anxiety
255
255
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
-
-