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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
  1.  K090935  MINIME PEDIATRIC MASK
  2.  K102317  IQ VENTILATION NASAL MASK
  3.  K120463  MOJO, VERASEAL
  4.  K121321  HARD SHELL VENTED NASAL MASK
  5.  K121692  MINIME 2 NASAL MASK
  6.  K190254  Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face ...
  7.  K203601  Innova Nasal Non-Vented Mask
  8.  K211274  iQ 2 Nasal Mask, Phantom 2 Nasal Mask
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 28147 28147

Device Problems MDRs with this Device Problem Events in those MDRs
Degraded 146574 146574
Contamination 2757 2757
Corroded 2452 2452
Nonstandard Device 761 761
Adverse Event Without Identified Device or Use Problem 541 541
Patient-Device Incompatibility 390 390
Device Emits Odor 354 354
Smoking 227 227
Overheating of Device 225 225
Insufficient Information 224 224
Fire 212 212
Material Integrity Problem 196 196
Excessive Heating 158 158
Noise, Audible 155 155
Patient Device Interaction Problem 149 149
Device Operates Differently Than Expected 126 126
Contamination /Decontamination Problem 123 123
Particulates 108 108
Failure to Power Up 100 100
Mechanical Problem 100 100
Device Contamination with Chemical or Other Material 98 98
No Apparent Adverse Event 77 77
Thermal Decomposition of Device 76 76
Break 73 73
Disconnection 69 69
Product Quality Problem 56 56
Temperature Problem 55 55
Pressure Problem 51 51
Defective Device 49 49
Power Problem 45 45
Appropriate Term/Code Not Available 41 41
Use of Device Problem 41 41
Electrical /Electronic Property Problem 40 40
Circuit Failure 40 40
Obstruction of Flow 39 39
Unexpected Shutdown 38 38
Peeled/Delaminated 37 37
Detachment of Device or Device Component 36 36
Complete Loss of Power 35 35
Sparking 35 35
Device Displays Incorrect Message 34 34
Decrease in Pressure 33 33
No Display/Image 33 33
Melted 30 30
Device Issue 30 30
Increase in Pressure 29 29
Leak/Splash 29 29
Therapeutic or Diagnostic Output Failure 28 28
Output Problem 27 27
Connection Problem 27 27
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 18 18
Unraveled Material 16 16
Device Inoperable 15 15
Calcified 15 15
No Audible Alarm 15 15
Material Discolored 14 14
Material Fragmentation 14 14
Material Separation 14 14
Material Deformation 14 14
Intermittent Loss of Power 14 14
Gas/Air Leak 13 13
Improper Flow or Infusion 13 13
Component Missing 13 13
Material Erosion 13 13
Display or Visual Feedback Problem 13 13
Use of Incorrect Control/Treatment Settings 12 12
Computer Software 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
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
Device Slipped 7 7
Loss of Power 7 7
Inaccurate Delivery 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

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 93015 93015
Unspecified Respiratory Problem 16340 16340
Headache 15793 15794
Dyspnea 11618 11618
Dizziness 8744 8744
Respiratory Tract Infection 8648 8648
Cancer 8088 8088
Sore Throat 7973 7973
Asthma 7695 7695
Cough 7261 7261
Unspecified Kidney or Urinary Problem 3772 3772
Nausea 3271 3271
Skin Inflammation/ Irritation 2876 2876
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2857 2857
Inflammation 2305 2305
Unspecified Heart Problem 2011 2011
Vomiting 1997 1997
Hypersensitivity/Allergic reaction 1897 1897
Dry Mouth 1834 1834
Chest Pain 1455 1455
Insufficient Information 1388 1388
Chronic Obstructive Pulmonary Disease (COPD) 1206 1206
Sleep Dysfunction 1125 1125
Epistaxis 1028 1028
Unspecified Hepatic or Biliary Problem 931 931
Fatigue 928 928
Pneumonia 895 895
Nodule 704 704
Heart Failure/Congestive Heart Failure 679 679
Dry Eye(s) 590 590
Bronchitis 590 590
Liver Damage/Dysfunction 545 545
Pain 529 529
Unspecified Eye / Vision Problem 518 518
Apnea 462 462
Sneezing 418 418
High Blood Pressure/ Hypertension 381 381
Stroke/CVA 380 380
Burning Sensation 376 376
Swelling/ Edema 330 330
Nasal Obstruction 317 317
Pulmonary Dysfunction 309 309
Choking 308 308
Rash 302 302
Wheezing 273 273
Respiratory Failure 252 252
Anxiety 251 251
Breast Cancer 247 247
Unspecified Infection 241 241
Lymphoma 206 206
Unspecified Ear or Labyrinth Problem 201 201
No Consequences Or Impact To Patient 199 199
Unspecified Gastrointestinal Problem 196 196
Atrial Fibrillation 194 194
Cardiac Arrest 179 179
Hemoptysis 177 177
Low Oxygen Saturation 176 176
Memory Loss/Impairment 166 166
Cardiovascular Insufficiency 164 164
No Patient Involvement 163 163
Fibrosis 161 161
Pharyngitis 156 156
No Known Impact Or Consequence To Patient 155 155
Renal Failure 153 153
Solid Tumour 146 146
Eye Infections 144 144
Excessive Tear Production 144 144
Myocardial Infarction 134 134
Eye Pain 129 129
Itching Sensation 127 127
Red Eye(s) 126 126
Speech Disorder 121 121
Arrhythmia 110 110
Pulmonary Embolism 101 101
Convulsion/Seizure 101 101
Unspecified Blood or Lymphatic problem 100 100
Pulmonary Emphysema 100 100
Vertigo 100 100
Renal Impairment 94 94
Taste Disorder 93 93
Pulmonary Hypertension 86 86
Ulcer 86 86
Sinus Perforation 84 84
Bacterial Infection 83 83
Unspecified Immune System Problem 83 83
Aspiration/Inhalation 82 82
Hemorrhage/Bleeding 82 82
Angina 81 81
Discomfort 81 81
Fluid Discharge 80 80
Eye Burn 77 77
Weight Changes 75 75
Cyst(s) 75 75
Hypoxia 74 74
Abdominal Pain 73 73
Swollen Lymph Nodes/Glands 70 70
Adult Respiratory Distress Syndrome 69 69
Pleural Effusion 65 65
Embolism/Embolus 64 64
Respiratory Insufficiency 63 63

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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