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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 13176 13176

Device Problems MDRs with this Device Problem Events in those MDRs
Degraded 132029 132029
Contamination 2718 2718
Corroded 2451 2451
Nonstandard Device 760 760
Adverse Event Without Identified Device or Use Problem 413 413
Patient-Device Incompatibility 390 390
Device Emits Odor 344 344
Overheating of Device 220 220
Smoking 214 214
Fire 207 207
Insufficient Information 187 187
Excessive Heating 155 155
Material Integrity Problem 154 154
Noise, Audible 150 150
Patient Device Interaction Problem 144 144
Device Operates Differently Than Expected 126 126
Contamination /Decontamination Problem 115 115
Particulates 106 106
Failure to Power Up 98 98
Mechanical Problem 98 98
Device Contamination with Chemical or Other Material 97 97
Thermal Decomposition of Device 75 75
Break 71 71
No Apparent Adverse Event 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
Use of Device Problem 41 41
Obstruction of Flow 39 39
Circuit Failure 39 39
Appropriate Term/Code Not Available 39 39
Unexpected Shutdown 37 37
Electrical /Electronic Property Problem 37 37
Complete Loss of Power 35 35
Device Displays Incorrect Message 34 34
Sparking 34 34
Detachment of Device or Device Component 33 33
No Display/Image 32 32
Decrease in Pressure 31 31
Device Issue 30 30
Melted 30 30
Therapeutic or Diagnostic Output Failure 28 28
Output Problem 27 27
Increase in Pressure 27 27
Leak/Splash 26 26
Connection Problem 26 26
Loose or Intermittent Connection 25 25
Material Disintegration 25 25
Insufficient Heating 22 22
Defective Component 22 22
Fitting Problem 21 21
Improper or Incorrect Procedure or Method 21 21
Moisture or Humidity Problem 20 20
Device Markings/Labelling Problem 19 19
Unintended Movement 18 18
Material Split, Cut or Torn 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
Fluid/Blood Leak 11 11
Solder Joint Fracture 11 11
Insufficient Flow or Under Infusion 10 10
Material Deformation 10 10
Scratched Material 10 10
Flare or Flash 9 9
No Pressure 9 9
Chemical Problem 9 9
Failure to Deliver 9 9
Unexpected Therapeutic Results 8 8
Unintended Electrical Shock 8 8
Human-Device Interface Problem 7 7
Infusion or Flow Problem 7 7
Contamination of Device Ingredient or Reagent 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
Device Operational Issue 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 91201 91201
Headache 12626 12627
Dyspnea 11336 11336
Unspecified Respiratory Problem 10910 10910
Respiratory Tract Infection 7962 7962
Sore Throat 7912 7912
Cough 7012 7012
Dizziness 5577 5577
Cancer 4671 4671
Asthma 3063 3063
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2471 2471
Nausea 2323 2323
Unspecified Kidney or Urinary Problem 1912 1912
Skin Inflammation/ Irritation 1779 1779
Dry Mouth 1774 1774
Chest Pain 1384 1384
Unspecified Heart Problem 1261 1261
Insufficient Information 1167 1167
Sleep Dysfunction 1097 1097
Inflammation 1085 1085
Vomiting 1062 1062
Hypersensitivity/Allergic reaction 1057 1057
Epistaxis 1012 1012
Fatigue 892 892
Pneumonia 698 698
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 450 450
Bronchitis 417 417
Sneezing 415 415
Unspecified Hepatic or Biliary Problem 394 394
Burning Sensation 367 367
High Blood Pressure/ Hypertension 338 338
Stroke/CVA 327 327
Liver Damage/Dysfunction 325 325
Swelling/ Edema 320 320
Choking 302 302
Nasal Obstruction 301 301
Rash 294 294
Wheezing 250 250
Anxiety 235 235
Unspecified Infection 233 233
Pulmonary Dysfunction 205 205
No Consequences Or Impact To Patient 199 199
Unspecified Ear or Labyrinth Problem 191 191
Hemoptysis 173 173
Breast Cancer 173 173
Low Oxygen Saturation 170 170
No Patient Involvement 163 163
Atrial Fibrillation 160 160
Unspecified Gastrointestinal Problem 159 159
No Known Impact Or Consequence To Patient 155 155
Memory Loss/Impairment 153 153
Cardiac Arrest 152 152
Respiratory Failure 151 151
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
Fibrosis 123 123
Solid Tumour 123 123
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 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 65 65
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 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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