• 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 3
RESMED PTY LTD
  SUBSTANTIALLY EQUIVALENT 1
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

MDR Year MDR Reports MDR Events
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 194481 194482
Contamination 4135 4135
Corroded 2462 2462
Adverse Event Without Identified Device or Use Problem 2018 2018
Nonstandard Device 758 758
Insufficient Information 414 414
Patient-Device Incompatibility 399 399
Device Emits Odor 389 389
Material Integrity Problem 349 349
Overheating of Device 328 328
Smoking 303 303
No Apparent Adverse Event 279 279
Excessive Heating 185 185
Noise, Audible 178 178
Power Problem 173 173
Fire 160 160
Patient Device Interaction Problem 153 153
Contamination /Decontamination Problem 144 144
Failure to Power Up 137 137
Temperature Problem 132 132
Electrical /Electronic Property Problem 120 120
Particulates 110 110
Device Contamination with Chemical or Other Material 107 107
Mechanical Problem 97 97
Circuit Failure 95 95
Thermal Decomposition of Device 80 80
Unexpected Shutdown 59 59
Break 56 56
Display or Visual Feedback Problem 52 52
Product Quality Problem 51 51
Activation Problem 51 51
Defective Device 45 45
Pressure Problem 44 44
Complete Loss of Power 40 40
Appropriate Term/Code Not Available 40 40
Sparking 38 38
Unraveled Material 37 37
Peeled/Delaminated 37 37
Obstruction of Flow 36 36
Decrease in Pressure 36 36
Disconnection 32 32
Material Disintegration 32 32
Use of Device Problem 32 32
Leak/Splash 32 32
Increase in Pressure 31 31
Insufficient Heating 27 27
Melted 26 26
Crack 26 26
Therapeutic or Diagnostic Output Failure 25 25
Output Problem 24 24

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 109278 109278
Unspecified Respiratory Problem 34643 34644
Headache 26743 26743
Dizziness 19562 19562
Cancer 18931 18931
Asthma 15200 15201
Dyspnea 12506 12506
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 6818 6818
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 1638 1638
Pneumonia 1538 1538
Heart Failure/Congestive Heart Failure 1384 1384
Pulmonary Dysfunction 1234 1234
Sleep Dysfunction 1207 1207
Epistaxis 1111 1111
Bronchitis 1056 1056
Liver Damage/Dysfunction 1056 1056
Fatigue 1055 1055
Nodule 909 909
Respiratory Failure 653 653
Dry Eye(s) 608 608
Unspecified Eye / Vision Problem 566 566
Stroke/CVA 566 566
Pain 559 559
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 340 340
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 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
-
-