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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
FISHER AND PAYKEL HEALTHCARE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS RESPIRONICS
  SUBSTANTIALLY EQUIVALENT 1
REMSLEEP HOLDINGS
  SUBSTANTIALLY EQUIVALENT 1
RESMED CORP
  SUBSTANTIALLY EQUIVALENT 3
RESMED LTD
  SUBSTANTIALLY EQUIVALENT 1
RESMED PTY LTD
  SUBSTANTIALLY EQUIVALENT 1
RESMED PTY LTD (REGISTRATION NUMBER: 3004604967)
  SUBSTANTIALLY EQUIVALENT 3
RESPIRONICS INC.
  SUBSTANTIALLY EQUIVALENT 3
RESPIRONICS, INC.
  SUBSTANTIALLY EQUIVALENT 4
SLEEPNET CORPORATION
  SUBSTANTIALLY EQUIVALENT 5
SUZHOU YUYUE MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
  1.  K203347  Sleep Apnea Breathing Therapy Mask: YF-01 Full Fac ...
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 47441 47441

Device Problems MDRs with this Device Problem Events in those MDRs
Degraded 165146 165146
Contamination 3610 3610
Corroded 2459 2459
Adverse Event Without Identified Device or Use Problem 1034 1034
Nonstandard Device 758 758
Patient-Device Incompatibility 390 390
Device Emits Odor 363 363
Smoking 247 247
Insufficient Information 244 244
Overheating of Device 234 234
Material Integrity Problem 228 228
Fire 167 167
Noise, Audible 162 162
Excessive Heating 161 161
Patient Device Interaction Problem 149 149
Contamination /Decontamination Problem 129 129
Particulates 108 108
Temperature Problem 107 107
Mechanical Problem 105 105
Device Contamination with Chemical or Other Material 100 100
Failure to Power Up 99 99
No Apparent Adverse Event 88 88
Thermal Decomposition of Device 62 62
Break 62 62
Disconnection 57 57
Product Quality Problem 52 52
Defective Device 46 46
Power Problem 43 43
Unexpected Shutdown 42 42
Pressure Problem 41 41
Circuit Failure 39 39
Obstruction of Flow 38 38
Peeled/Delaminated 37 37
Activation Problem 36 36
Complete Loss of Power 35 35
Decrease in Pressure 35 35
Appropriate Term/Code Not Available 34 34
Use of Device Problem 32 32
Detachment of Device or Device Component 32 32
Electrical /Electronic Property Problem 32 32
Sparking 31 31
Leak/Splash 29 29
Increase in Pressure 29 29
Therapeutic or Diagnostic Output Failure 28 28
Output Problem 26 26
Melted 26 26
Unraveled Material 25 25
Material Disintegration 24 24
Insufficient Heating 23 23
Connection Problem 22 22

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 97862 97862
Unspecified Respiratory Problem 24272 24272
Headache 20604 20604
Dizziness 13564 13564
Cancer 12582 12582
Dyspnea 11918 11918
Asthma 11249 11249
Respiratory Tract Infection 9409 9409
Sore Throat 8066 8066
Cough 7514 7514
Unspecified Kidney or Urinary Problem 7186 7186
Skin Inflammation/ Irritation 5005 5005
Nausea 4839 4839
Inflammation 4292 4292
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3659 3659
Vomiting 3520 3520
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 1503 1503
Sleep Dysfunction 1144 1144
Pneumonia 1087 1087
Epistaxis 1062 1062
Fatigue 960 960
Heart Failure/Congestive Heart Failure 954 954
Liver Damage/Dysfunction 917 917
Nodule 784 784
Bronchitis 758 758
Dry Eye(s) 594 594
Unspecified Eye / Vision Problem 535 535
Pain 533 533
Pulmonary Dysfunction 469 469
Apnea 466 466
Stroke/CVA 456 456
High Blood Pressure/ Hypertension 437 437
Sneezing 429 429
Respiratory Failure 380 380
Burning Sensation 372 372
Swelling/ Edema 343 343
Breast Cancer 337 337
Nasal Obstruction 328 328
Choking 319 319
Cardiovascular Insufficiency 315 315
Rash 303 303
Lymphoma 302 302
Wheezing 285 285
Anxiety 255 255

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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