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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 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
  1.  K181053  Care Orchestrator
  2.  K183226  Care Orchestrator Essence
  3.  K231313  Therapy Mask 3100 NC/SP
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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