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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 5
3B MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 4
3B PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
3B PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 2
A PLUS MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
AEIOMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
AIRWAY MANAGEMENT, INC.
  SUBSTANTIALLY EQUIVALENT 1
APEX MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 9
BMC MEDICAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
BMC MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BMC MEDICAL.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
BREATHE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
CARDINAL HEALTH 207, INC.
  SUBSTANTIALLY EQUIVALENT 1
CHILDRENS MEDICAL VENTURES LLC
  SUBSTANTIALLY EQUIVALENT 1
CIRCADIANCE LLC
  SUBSTANTIALLY EQUIVALENT 3
CIRCADIANCE, LLC
  SUBSTANTIALLY EQUIVALENT 2
CURATIVE MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 5
DESHUM MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
DEVILBISS HEALTHCARE LLC
  SUBSTANTIALLY EQUIVALENT 2
DEVILBISS HEALTHCARE, LLC
  SUBSTANTIALLY EQUIVALENT 2
FISHER & PAYKEL HEALTHCARE LIMITED
  SUBSTANTIALLY EQUIVALENT 4
FISHER & PAYKEL HEALTHCARE LTD
  SUBSTANTIALLY EQUIVALENT 4
FISHER & PAYKEL HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 4
FISHER & PAYKEL HEALTHCARE, LTD.
  SUBSTANTIALLY EQUIVALENT 5
HSINER COMPANY
  SUBSTANTIALLY EQUIVALENT 1
HUMAN DESIGN MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
INNOMED TECHNOLOGIES INC./RESPCARE INC.
  SUBSTANTIALLY EQUIVALENT 1
INSLEEP TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
INTERSURGICAL INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
LAKEVIEW SLEEP CENTER
  SUBSTANTIALLY EQUIVALENT 1
PUR-SLEEP, INC.
  SUBSTANTIALLY EQUIVALENT 1
RESMED CORP
  SUBSTANTIALLY EQUIVALENT 3
RESMED CORP.
  SUBSTANTIALLY EQUIVALENT 2
RESMED LTD
  SUBSTANTIALLY EQUIVALENT 9
RESMED LTD.
  SUBSTANTIALLY EQUIVALENT 30
RESMED PTY LTD
  SUBSTANTIALLY EQUIVALENT 1
RESMED PTY LTD (REGISTRATION NUMBER: 3004604967)
  SUBSTANTIALLY EQUIVALENT 2
RESPIRONICS INC.
  SUBSTANTIALLY EQUIVALENT 6
RESPIRONICS INC. (DBA PHILIPS RESPIRONICS)
  SUBSTANTIALLY EQUIVALENT 1
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP
  SUBSTANTIALLY EQUIVALENT 7
RESPIRONICS, INC.
  SUBSTANTIALLY EQUIVALENT 22
SALTER LABS
  SUBSTANTIALLY EQUIVALENT 1
SEATTLE CHILDRENS HOSPITAL
  SUBSTANTIALLY EQUIVALENT 1
SKY WISE MEDICAL INSTRUMENT (SHEN ZHEN) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SLEEPNET CORPORATION
  SUBSTANTIALLY EQUIVALENT 8
SNAPCPAP
  SUBSTANTIALLY EQUIVALENT 1
SOMNETICS INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
STEVENSON INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
SUNRISE MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
SUZHOU YUYUE MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SYSMED (CHINA) CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
VEGA TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
WEINMANN GERATE FUR MEDIZIN GMBH + CO. KG
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2014 85 85
2015 114 114
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 19822 19822

Device Problems MDRs with this Device Problem Events in those MDRs
Degraded 138497 138497
Contamination 2745 2745
Corroded 2452 2452
Nonstandard Device 761 761
Adverse Event Without Identified Device or Use Problem 457 457
Patient-Device Incompatibility 390 390
Device Emits Odor 351 351
Overheating of Device 223 223
Smoking 219 219
Fire 210 210
Insufficient Information 192 192
Material Integrity Problem 177 177
Excessive Heating 157 157
Noise, Audible 154 154
Patient Device Interaction Problem 146 146
Device Operates Differently Than Expected 126 126
Contamination /Decontamination Problem 117 117
Particulates 106 106
Failure to Power Up 99 99
Mechanical Problem 99 99
Device Contamination with Chemical or Other Material 98 98
Thermal Decomposition of Device 75 75
No Apparent Adverse Event 73 73
Break 71 71
Disconnection 69 69
Product Quality Problem 56 56
Temperature Problem 54 54
Pressure Problem 51 51
Defective Device 49 49
Power Problem 44 44
Appropriate Term/Code Not Available 41 41
Use of Device Problem 41 41
Circuit Failure 40 40
Electrical /Electronic Property Problem 39 39
Obstruction of Flow 39 39
Unexpected Shutdown 38 38
Complete Loss of Power 35 35
Detachment of Device or Device Component 34 34
Device Displays Incorrect Message 34 34
Sparking 34 34
No Display/Image 33 33
Decrease in Pressure 32 32
Device Issue 30 30
Melted 30 30
Leak/Splash 29 29
Increase in Pressure 28 28
Therapeutic or Diagnostic Output Failure 28 28
Output Problem 27 27
Connection Problem 26 26
Loose or Intermittent Connection 25 25
Material Disintegration 25 25
Improper or Incorrect Procedure or Method 23 23
Defective Component 22 22
Insufficient Heating 22 22
Fitting Problem 21 21
Moisture or Humidity Problem 20 20
Material Split, Cut or Torn 20 20
Device Markings/Labelling Problem 19 19
Unintended Movement 18 18
Crack 17 17
Device Inoperable 15 15
Material Separation 14 14
Calcified 14 14
Material Fragmentation 14 14
Intermittent Loss of Power 14 14
Gas/Air Leak 13 13
Improper Flow or Infusion 13 13
Material Erosion 13 13
No Audible Alarm 13 13
Material Discolored 13 13
Unraveled Material 13 13
Component Missing 13 13
Use of Incorrect Control/Treatment Settings 12 12
Computer Software Problem 12 12
Display or Visual Feedback Problem 12 12
Manufacturing, Packaging or Shipping Problem 12 12
Material Deformation 12 12
Fluid/Blood Leak 11 11
Solder Joint Fracture 11 11
Insufficient Flow or Under Infusion 10 10
Scratched Material 10 10
No Pressure 9 9
Flare or Flash 9 9
Chemical Problem 9 9
Failure to Deliver 9 9
Unexpected Therapeutic Results 8 8
Contamination of Device Ingredient or Reagent 8 8
Unintended Electrical Shock 8 8
Human-Device Interface Problem 7 7
Infusion or Flow Problem 7 7
Inaccurate Delivery 7 7
Device Slipped 7 7
Loss of Power 7 7
Electromagnetic Interference 7 7
Moisture Damage 7 7
Complete Blockage 7 7
Device Stops Intermittently 6 6
Compatibility Problem 6 6
Data Problem 6 6
Physical Resistance/Sticking 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 91835 91835
Headache 13590 13591
Unspecified Respiratory Problem 13064 13064
Dyspnea 11486 11486
Respiratory Tract Infection 8242 8242
Sore Throat 7945 7945
Cough 7133 7133
Dizziness 6522 6522
Cancer 6493 6493
Asthma 5141 5141
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2644 2644
Unspecified Kidney or Urinary Problem 2625 2625
Nausea 2587 2587
Skin Inflammation/ Irritation 2188 2188
Dry Mouth 1811 1811
Unspecified Heart Problem 1625 1625
Inflammation 1464 1464
Chest Pain 1420 1420
Hypersensitivity/Allergic reaction 1377 1377
Vomiting 1323 1323
Insufficient Information 1258 1258
Sleep Dysfunction 1118 1118
Epistaxis 1019 1019
Fatigue 911 911
Chronic Obstructive Pulmonary Disease (COPD) 879 879
Pneumonia 825 825
Nodule 683 683
Unspecified Hepatic or Biliary Problem 588 588
Dry Eye(s) 587 587
Heart Failure/Congestive Heart Failure 562 562
Pain 523 523
Unspecified Eye / Vision Problem 516 516
Bronchitis 496 496
Apnea 459 459
Sneezing 417 417
Liver Damage/Dysfunction 416 416
Burning Sensation 372 372
High Blood Pressure/ Hypertension 359 359
Stroke/CVA 354 354
Swelling/ Edema 326 326
Nasal Obstruction 309 309
Choking 305 305
Rash 299 299
Wheezing 262 262
Pulmonary Dysfunction 245 245
Anxiety 243 243
Unspecified Infection 238 238
Breast Cancer 212 212
Respiratory Failure 211 211
No Consequences Or Impact To Patient 199 199
Unspecified Ear or Labyrinth Problem 194 194
Atrial Fibrillation 180 180
Hemoptysis 174 174
Unspecified Gastrointestinal Problem 172 172
Low Oxygen Saturation 171 171
Cardiac Arrest 164 164
No Patient Involvement 163 163
Memory Loss/Impairment 159 159
Lymphoma 159 159
No Known Impact Or Consequence To Patient 155 155
Pharyngitis 153 153
Fibrosis 151 151
Excessive Tear Production 144 144
Eye Infections 142 142
Renal Failure 140 140
Solid Tumour 137 137
Eye Pain 129 129
Itching Sensation 127 127
Red Eye(s) 126 126
Speech Disorder 121 121
Myocardial Infarction 118 118
Cardiovascular Insufficiency 116 116
Arrhythmia 106 106
Convulsion/Seizure 97 97
Unspecified Blood or Lymphatic problem 94 94
Pulmonary Embolism 94 94
Vertigo 93 93
Renal Impairment 93 93
Taste Disorder 92 92
Ulcer 86 86
Pulmonary Emphysema 84 84
Sinus Perforation 83 83
Discomfort 81 81
Bacterial Infection 81 81
Angina 79 79
Hemorrhage/Bleeding 79 79
Fluid Discharge 79 79
Aspiration/Inhalation 78 78
Eye Burn 77 77
Pulmonary Hypertension 76 76
Weight Changes 74 74
Cyst(s) 71 71
Abdominal Pain 70 70
Swollen Lymph Nodes/Glands 68 68
Hypoxia 66 66
Embolism/Embolus 64 64
Blurred Vision 61 61
Adult Respiratory Distress Syndrome 60 60
Fever 60 60
Respiratory Insufficiency 60 60

Recalls
Manufacturer Recall Class Date Posted
1 Beevers Manufacturing & Supply, Inc. II Dec-02-2014
2 Beevers Manufacturing & Supply, Inc. II Dec-01-2014
3 Compass Health Brands (Corporate Office) I Aug-20-2018
4 DeVilbiss Healthcare LLC III Jul-01-2014
5 Draeger Medical, Inc. I May-17-2023
6 Fisher & Paykel Healthcare, Ltd. II May-30-2013
7 Galemed Corporation I Dec-20-2019
8 Philips Respironics, Inc. I Apr-06-2023
9 Philips Respironics, Inc. I Sep-30-2022
10 Philips Respironics, Inc. I Jul-13-2021
11 ResMed Ltd. I Dec-21-2023
12 Resmed Corporation II Aug-16-2016
13 Respironics II Jun-17-2009
14 SleepNet Corporation I Apr-01-2024
15 Sunrise Medical HHG Inc. dba DeVilbiss Healthcare II Aug-10-2011
16 TELEFLEX-MORRISVILLE I Nov-07-2019
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