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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)
Regulation Description Noncontinuous ventilator (IPPB).
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 2
FISHER & PAYKEL HEALTHCARE LTD
  SUBSTANTIALLY EQUIVALENT 3
FISHER & PAYKEL HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 2
FISHER AND PAYKEL HEALTHCARE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
GENADYNE BIOTECHNOLOGIES, INC.
  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 6
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 27994 27994
2024 68277 68278
2025 10522 10522

Device Problems MDRs with this Device Problem Events in those MDRs
Degraded 194484 194485
Contamination 4138 4138
Corroded 2462 2462
Adverse Event Without Identified Device or Use Problem 2033 2033
Nonstandard Device 759 759
Insufficient Information 430 430
Patient-Device Incompatibility 400 400
Device Emits Odor 391 391
Material Integrity Problem 349 349
Overheating of Device 329 329
Smoking 304 304
No Apparent Adverse Event 279 279
Excessive Heating 185 185
Fire 183 183
Noise, Audible 181 181
Power Problem 174 174
Patient Device Interaction Problem 155 155
Contamination /Decontamination Problem 144 144
Failure to Power Up 137 137
Temperature Problem 133 133
Mechanical Problem 132 132
Electrical /Electronic Property Problem 121 121
Particulates 110 110
Device Contamination with Chemical or Other Material 109 109
Circuit Failure 95 95
Thermal Decomposition of Device 83 83
Break 65 65
Unexpected Shutdown 59 59
Disconnection 57 57
Display or Visual Feedback Problem 53 53
Product Quality Problem 52 52
Activation Problem 51 51
Pressure Problem 47 47
Defective Device 46 46
Complete Loss of Power 40 40
Obstruction of Flow 40 40
Appropriate Term/Code Not Available 40 40
Sparking 38 38
Unraveled Material 37 37
Peeled/Delaminated 37 37
Decrease in Pressure 36 36
Use of Device Problem 33 33
Leak/Splash 33 33
Increase in Pressure 32 32
Material Disintegration 32 32
Detachment of Device or Device Component 32 32
Therapeutic or Diagnostic Output Failure 28 28
Insufficient Heating 27 27
Melted 27 27
Crack 26 26

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 109281 109281
Unspecified Respiratory Problem 34643 34644
Headache 26744 26744
Dizziness 19563 19563
Cancer 18931 18931
Asthma 15201 15202
Dyspnea 12511 12511
Unspecified Kidney or Urinary Problem 11076 11076
Respiratory Tract Infection 9806 9806
Sore Throat 8268 8268
Cough 8004 8004
Skin Inflammation/ Irritation 7385 7385
Inflammation 6835 6836
Nausea 6819 6819
Vomiting 5444 5444
Hypersensitivity/Allergic reaction 4976 4976
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4340 4340
Insufficient Information 4051 4051
Unspecified Heart Problem 3844 3844
Unspecified Hepatic or Biliary Problem 3250 3250
Chronic Obstructive Pulmonary Disease (COPD) 2345 2345
Dry Mouth 1975 1975
Chest Pain 1639 1639
Pneumonia 1539 1539
Heart Failure/Congestive Heart Failure 1384 1384
Pulmonary Dysfunction 1234 1234
Sleep Dysfunction 1207 1207
Epistaxis 1111 1111
Bronchitis 1057 1057
Fatigue 1056 1056
Liver Damage/Dysfunction 1056 1056
Nodule 909 909
Respiratory Failure 655 655
Dry Eye(s) 608 608
Unspecified Eye / Vision Problem 566 566
Stroke/CVA 566 566
Pain 561 561
High Blood Pressure/ Hypertension 510 510
Breast Cancer 488 488
Apnea 481 481
Sneezing 451 451
Lymphoma 451 451
Cardiovascular Insufficiency 425 425
Burning Sensation 379 379
Swelling/ Edema 370 370
Choking 341 341
Nasal Obstruction 338 338
Wheezing 320 320
Myocardial Infarction 319 319
Rash 318 318

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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