• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 1
BMC MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
FISHER & PAYKEL HEALTHCARE LTD
  SUBSTANTIALLY EQUIVALENT 3
FISHER & PAYKEL HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 1
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 4
RESMED PTY LTD
  SUBSTANTIALLY EQUIVALENT 2
RESMED PTY LTD (REGISTRATION NUMBER: 3004604967)
  SUBSTANTIALLY EQUIVALENT 3
RESPIRONICS INC.
  SUBSTANTIALLY EQUIVALENT 1
RESPIRONICS, INC.
  SUBSTANTIALLY EQUIVALENT 4
SLEEPNET CORPORATION
  SUBSTANTIALLY EQUIVALENT 5
SUZHOU YUYUE MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SYSMED (CHINA) CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
WELLELL INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 126 126
2021 6062 6062
2022 90783 90783
2023 27992 27992
2024 68277 68277
2025 45590 45590

Device Problems MDRs with this Device Problem Events in those MDRs
Degraded 228404 228404
Contamination 5453 5453
Adverse Event Without Identified Device or Use Problem 2598 2598
Corroded 2464 2464
Nonstandard Device 761 761
Device Emits Odor 517 517
Insufficient Information 440 440
No Apparent Adverse Event 407 407
Patient-Device Incompatibility 401 401
Overheating of Device 395 395
Material Integrity Problem 377 377
Smoking 323 323
Contamination /Decontamination Problem 235 235
Power Problem 217 217
Noise, Audible 214 214
Excessive Heating 211 211
Temperature Problem 169 169
Fire 168 168
Electrical /Electronic Property Problem 168 168
Patient Device Interaction Problem 164 164
Failure to Power Up 154 154
Device Contamination with Chemical or Other Material 138 138
Circuit Failure 114 114
Particulates 111 111
Mechanical Problem 104 104
Thermal Decomposition of Device 98 98
Unexpected Shutdown 70 70
Break 62 62
Display or Visual Feedback Problem 61 61
Activation Problem 58 58
Product Quality Problem 52 52
Defective Device 48 48
Pressure Problem 47 47
Appropriate Term/Code Not Available 46 46
Sparking 46 46
Complete Loss of Power 45 45
Unraveled Material 43 43
Obstruction of Flow 40 40
Decrease in Pressure 38 38
Peeled/Delaminated 37 37
Environmental Particulates 35 35
Leak/Splash 35 35
Increase in Pressure 33 33
Material Disintegration 33 33
Disconnection 33 33
Use of Device Problem 33 33
Crack 31 31
Insufficient Heating 30 30
Melted 27 27
Therapeutic or Diagnostic Output Failure 26 26

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 143677 143677
Unspecified Respiratory Problem 34892 34892
Headache 26889 26889
Dizziness 19644 19644
Cancer 19082 19082
Asthma 15263 15263
Dyspnea 12604 12604
Unspecified Kidney or Urinary Problem 11138 11138
Respiratory Tract Infection 9818 9818
Sore Throat 8313 8313
Cough 8085 8085
Skin Inflammation/ Irritation 7411 7411
Inflammation 6862 6862
Nausea 6844 6844
Vomiting 5464 5464
Hypersensitivity/Allergic reaction 4994 4994
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4382 4382
Insufficient Information 4209 4209
Unspecified Heart Problem 3874 3874
Unspecified Hepatic or Biliary Problem 3266 3266
Chronic Obstructive Pulmonary Disease (COPD) 2366 2366
Dry Mouth 2002 2002
Chest Pain 1648 1648
Pneumonia 1553 1553
Heart Failure/Congestive Heart Failure 1394 1394
Pulmonary Dysfunction 1242 1242
Sleep Dysfunction 1226 1226
Epistaxis 1120 1120
Fatigue 1066 1066
Bronchitis 1064 1064
Liver Damage/Dysfunction 1059 1059
Nodule 921 921
Respiratory Failure 657 657
Dry Eye(s) 610 610
Stroke/CVA 574 574
Unspecified Eye / Vision Problem 572 572
Pain 563 563
High Blood Pressure/ Hypertension 519 519
Breast Cancer 490 490
Apnea 488 488
Sneezing 460 460
Lymphoma 455 455
Cardiovascular Insufficiency 427 427
Burning Sensation 387 387
Swelling/ Edema 373 373
Choking 347 347
Nasal Obstruction 340 340
Wheezing 323 323
Myocardial Infarction 321 321
Rash 320 320

Recalls
Manufacturer Recall Class Date Posted
1 Draeger Medical, Inc. I May-17-2023
2 Philips Respironics, Inc. I Apr-06-2023
3 Philips Respironics, Inc. I Sep-30-2022
4 Philips Respironics, Inc. I Jul-13-2021
5 ResMed Ltd. I Dec-21-2023
6 SleepNet Corporation I Apr-01-2024
-
-