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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
FISHER AND PAYKEL HEALTHCARE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
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
PHILIPS RESPIRONICS
  SUBSTANTIALLY EQUIVALENT 1
PUR-SLEEP, INC.
  SUBSTANTIALLY EQUIVALENT 1
REMSLEEP HOLDINGS
  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 10
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 47441 47441

Device Problems MDRs with this Device Problem Events in those MDRs
Degraded 165148 165148
Contamination 3614 3614
Corroded 2463 2463
Adverse Event Without Identified Device or Use Problem 1083 1083
Nonstandard Device 762 762
Patient-Device Incompatibility 395 395
Device Emits Odor 384 384
Insufficient Information 277 277
Smoking 250 250
Overheating of Device 241 241
Material Integrity Problem 235 235
Fire 222 222
Noise, Audible 165 165
Excessive Heating 161 161
Patient Device Interaction Problem 150 150
Contamination /Decontamination Problem 131 131
Device Operates Differently Than Expected 126 126
Temperature Problem 114 114
Mechanical Problem 111 111
Particulates 109 109
Failure to Power Up 105 105
Device Contamination with Chemical or Other Material 101 101
No Apparent Adverse Event 88 88
Thermal Decomposition of Device 82 82
Break 75 75
Disconnection 69 69
Product Quality Problem 56 56
Pressure Problem 51 51
Defective Device 49 49
Power Problem 45 45
Appropriate Term/Code Not Available 43 43
Unexpected Shutdown 43 43
Electrical /Electronic Property Problem 42 42
Use of Device Problem 41 41
Circuit Failure 41 41
Obstruction of Flow 39 39
Peeled/Delaminated 37 37
Detachment of Device or Device Component 36 36
Activation Problem 36 36
Complete Loss of Power 35 35
Decrease in Pressure 35 35
Sparking 35 35
Device Displays Incorrect Message 34 34
No Display/Image 33 33
Leak/Splash 33 33
Melted 31 31
Device Issue 30 30
Increase in Pressure 29 29
Therapeutic or Diagnostic Output Failure 28 28
Connection Problem 27 27

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 97864 97864
Unspecified Respiratory Problem 24272 24272
Headache 20611 20612
Dizziness 13564 13564
Cancer 12586 12586
Dyspnea 11930 11930
Asthma 11249 11249
Respiratory Tract Infection 9412 9412
Sore Throat 8066 8066
Cough 7514 7514
Unspecified Kidney or Urinary Problem 7186 7186
Skin Inflammation/ Irritation 5005 5005
Nausea 4841 4841
Inflammation 4293 4293
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3659 3659
Vomiting 3521 3521
Hypersensitivity/Allergic reaction 3329 3329
Unspecified Heart Problem 3104 3104
Dry Mouth 1880 1880
Unspecified Hepatic or Biliary Problem 1858 1858
Insufficient Information 1721 1721
Chronic Obstructive Pulmonary Disease (COPD) 1606 1606
Chest Pain 1507 1507
Sleep Dysfunction 1154 1154
Pneumonia 1091 1091
Epistaxis 1062 1062
Fatigue 964 964
Heart Failure/Congestive Heart Failure 954 954
Liver Damage/Dysfunction 917 917
Nodule 784 784
Bronchitis 760 760
Dry Eye(s) 595 595
Pain 536 536
Unspecified Eye / Vision Problem 535 535
Apnea 471 471
Pulmonary Dysfunction 469 469
Stroke/CVA 458 458
High Blood Pressure/ Hypertension 440 440
Sneezing 429 429
Respiratory Failure 382 382
Burning Sensation 380 380
Swelling/ Edema 343 343
Breast Cancer 337 337
Nasal Obstruction 328 328
Choking 321 321
Cardiovascular Insufficiency 315 315
Rash 305 305
Lymphoma 302 302
Wheezing 285 285
Anxiety 259 259

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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