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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device ventilator, non-continuous (respirator)
Product CodeBZD
Regulation Number 868.5905
Device Class 2


Premarket Reviews
ManufacturerDecision
3B MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 4
APEX MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 2
BMC MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BMC MEDICAL.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
CIRCADIANCE, LLC
  SUBSTANTIALLY EQUIVALENT 2
DEVILBISS HEALTHCARE, LLC
  SUBSTANTIALLY EQUIVALENT 1
FISHER & PAYKEL HEALTHCARE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
FISHER & PAYKEL HEALTHCARE LTD
  SUBSTANTIALLY EQUIVALENT 4
FISHER & PAYKEL HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 4
RESMED CORP
  SUBSTANTIALLY EQUIVALENT 1
RESMED LTD
  SUBSTANTIALLY EQUIVALENT 8
RESMED LTD.
  SUBSTANTIALLY EQUIVALENT 1
RESMED PTY LTD
  SUBSTANTIALLY EQUIVALENT 1
RESMED PTY LTD (REGISTRATION NUMBER: 3004604967)
  SUBSTANTIALLY EQUIVALENT 2
RESPIRONICS INC.
  SUBSTANTIALLY EQUIVALENT 4
RESPIRONICS, INC.
  SUBSTANTIALLY EQUIVALENT 5
SLEEPNET CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
SNAPCPAP
  SUBSTANTIALLY EQUIVALENT 1
  1.  K172335  Bleep DreamPort
SOMNETICS INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SUZHOU YUYUE MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SYSMED (CHINA) CO., LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 118 118
2017 148 148
2018 101 101
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 132028 132028
Contamination 2716 2716
Corroded 2447 2447
Nonstandard Device 758 758
Patient-Device Incompatibility 390 390
Adverse Event Without Identified Device or Use Problem 389 389
Device Emits Odor 336 336
Overheating of Device 218 218
Smoking 213 213
Fire 178 178
Insufficient Information 168 168
Excessive Heating 155 155
Material Integrity Problem 151 151
Noise, Audible 148 148
Patient Device Interaction Problem 144 144
Contamination /Decontamination Problem 115 115
Device Operates Differently Than Expected 111 111
Particulates 106 106
Mechanical Problem 98 98
Device Contamination with Chemical or Other Material 96 96
Failure to Power Up 94 94
No Apparent Adverse Event 71 71
Thermal Decomposition of Device 69 69
Break 66 66
Disconnection 65 65
Product Quality Problem 54 54
Pressure Problem 48 48
Temperature Problem 47 47
Defective Device 47 47
Power Problem 44 44
Obstruction of Flow 39 39
Use of Device Problem 38 38
Circuit Failure 37 37
Unexpected Shutdown 37 37
Complete Loss of Power 35 35
Detachment of Device or Device Component 33 33
Device Displays Incorrect Message 32 32
Electrical /Electronic Property Problem 32 32
Decrease in Pressure 31 31
Appropriate Term/Code Not Available 31 31
Sparking 30 30
Device Issue 30 30
No Display/Image 29 29
Therapeutic or Diagnostic Output Failure 28 28
Output Problem 27 27
Increase in Pressure 27 27
Connection Problem 25 25
Melted 25 25
Leak/Splash 24 24
Material Disintegration 24 24
Loose or Intermittent Connection 23 23
Insufficient Heating 22 22
Defective Component 22 22
Device Markings/Labelling Problem 19 19
Fitting Problem 19 19
Unintended Movement 18 18
Material Split, Cut or Torn 18 18
Moisture or Humidity Problem 16 16
Crack 15 15
Calcified 14 14
Material Fragmentation 14 14
Improper or Incorrect Procedure or Method 14 14
Material Separation 14 14
Intermittent Loss of Power 14 14
Gas/Air Leak 13 13
Improper Flow or Infusion 13 13
Unraveled Material 13 13
Component Missing 13 13
Material Erosion 13 13
Material Discolored 13 13
Computer Software Problem 12 12
Manufacturing, Packaging or Shipping Problem 12 12
No Audible Alarm 11 11
Fluid/Blood Leak 11 11
Insufficient Flow or Under Infusion 10 10
Scratched Material 10 10
Material Deformation 9 9
Failure to Deliver 9 9
Chemical Problem 9 9
Display or Visual Feedback Problem 9 9
Use of Incorrect Control/Treatment Settings 9 9
Unexpected Therapeutic Results 8 8
Device Inoperable 8 8
No Pressure 8 8
Flare or Flash 8 8
Unintended Electrical Shock 8 8
Infusion or Flow Problem 7 7
Contamination of Device Ingredient or Reagent 7 7
Electromagnetic Interference 7 7
Complete Blockage 7 7
Device Stops Intermittently 6 6
Compatibility Problem 6 6
Human-Device Interface Problem 6 6
Data Problem 6 6
Physical Resistance/Sticking 5 5
Device Slipped 5 5
Microbial Contamination of Device 5 5
Inaccurate Delivery 5 5
Fungus in Device Environment 5 5
Device Dislodged or Dislocated 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 91200 91200
Headache 12625 12626
Dyspnea 11332 11332
Unspecified Respiratory Problem 10910 10910
Respiratory Tract Infection 7961 7961
Sore Throat 7912 7912
Cough 7012 7012
Dizziness 5577 5577
Cancer 4669 4669
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 1381 1381
Unspecified Heart Problem 1261 1261
Insufficient Information 1167 1167
Sleep Dysfunction 1094 1094
Inflammation 1084 1084
Vomiting 1062 1062
Hypersensitivity/Allergic reaction 1057 1057
Epistaxis 1012 1012
Fatigue 891 891
Pneumonia 697 697
Chronic Obstructive Pulmonary Disease (COPD) 695 695
Nodule 642 642
Dry Eye(s) 585 585
Pain 508 508
Unspecified Eye / Vision Problem 508 508
Heart Failure/Congestive Heart Failure 450 450
Apnea 447 447
Bronchitis 417 417
Sneezing 415 415
Unspecified Hepatic or Biliary Problem 394 394
Burning Sensation 366 366
High Blood Pressure/ Hypertension 336 336
Liver Damage/Dysfunction 325 325
Stroke/CVA 325 325
Swelling/ Edema 320 320
Choking 301 301
Nasal Obstruction 301 301
Rash 293 293
Wheezing 250 250
Anxiety 233 233
Unspecified Infection 230 230
Pulmonary Dysfunction 205 205
Unspecified Ear or Labyrinth Problem 191 191
Hemoptysis 173 173
Breast Cancer 173 173
Low Oxygen Saturation 163 163
Atrial Fibrillation 160 160
Unspecified Gastrointestinal Problem 159 159
Memory Loss/Impairment 153 153
No Consequences Or Impact To Patient 152 152
Respiratory Failure 151 151
Cardiac Arrest 150 150
No Patient Involvement 146 146
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 124 124
Solid Tumour 123 123
Fibrosis 122 122
Speech Disorder 121 121
No Known Impact Or Consequence To Patient 115 115
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 84 84
Pulmonary Embolism 81 81
Sinus Perforation 80 80
Fluid Discharge 79 79
Angina 79 79
Unspecified Blood or Lymphatic problem 79 79
Bacterial Infection 78 78
Discomfort 77 77
Eye Burn 76 76
Aspiration/Inhalation 74 74
Hemorrhage/Bleeding 74 74
Abdominal Pain 70 70
Pulmonary Emphysema 70 70
Weight Changes 69 69
Pulmonary Hypertension 69 69
Swollen Lymph Nodes/Glands 67 67
Cyst(s) 66 66
Hypoxia 63 63
Embolism/Embolus 62 62
Blurred Vision 61 61
Fever 59 59
Pulmonary Edema 58 58
Numbness 58 58

Recalls
Manufacturer Recall Class Date Posted
1 Compass Health Brands (Corporate Office) I Aug-20-2018
2 Draeger Medical, Inc. I May-17-2023
3 Galemed Corporation I Dec-20-2019
4 Philips Respironics, Inc. I Apr-06-2023
5 Philips Respironics, Inc. I Sep-30-2022
6 Philips Respironics, Inc. I Jul-13-2021
7 ResMed Ltd. I Dec-21-2023
8 Resmed Corporation II Aug-16-2016
9 SleepNet Corporation I Apr-01-2024
10 TELEFLEX-MORRISVILLE I Nov-07-2019
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