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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device ventilator, continuous, facility use
Product CodeCBK
Regulation Number 868.5895
Device Class 2


Premarket Reviews
ManufacturerDecision
BIO-MED DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1
BREATHE TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN, LLC
  SUBSTANTIALLY EQUIVALENT 1
DATEX-OHMEDA, INC.
  SUBSTANTIALLY EQUIVALENT 1
DRAGERWERK AG & CO. KGAA
  SUBSTANTIALLY EQUIVALENT 1
FISHER & PAYKEL HEALTHCARE LTD
  SUBSTANTIALLY EQUIVALENT 1
FISHER AND PAYKEL HEALTHCARE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
HAMILTON MEDICAL AG
  SUBSTANTIALLY EQUIVALENT 5
HAMITON MEDICAL AG
  SUBSTANTIALLY EQUIVALENT 1
IMTMEDICAL AG
  SUBSTANTIALLY EQUIVALENT 2
INOVYTECH MEDICAL SOLUTIONS LTD.
  SUBSTANTIALLY EQUIVALENT 1
MAQUET CRITICA CARE AB
  SUBSTANTIALLY EQUIVALENT 1
MAQUET CRITICAL CARE AB
  SUBSTANTIALLY EQUIVALENT 2
NIHON KOHDEN ORANGEMED, INC.
  SUBSTANTIALLY EQUIVALENT 2
RESMED LTD
  SUBSTANTIALLY EQUIVALENT 1
RESPIRONICS INC.
  SUBSTANTIALLY EQUIVALENT 2
SLEEPNET CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
VENTEC LIFE SYSTEMS, INC
  SUBSTANTIALLY EQUIVALENT 1
VYAIRE MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 1
ZOLL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 14451 14451
2018 9848 9848
2019 9099 9501
2020 11097 11097
2021 13328 13328
2022 12911 12911

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 9100 9100
Device Displays Incorrect Message 6187 6187
Output Problem 5667 5667
Circuit Failure 4614 4614
Battery Problem 4176 4210
No Display/Image 3840 3840
Device Operates Differently Than Expected 3745 3745
Failure to Recalibrate 3442 3442
Failure to Calibrate 2776 3042
Failure to Charge 2361 2377
Device Inoperable 1968 1968
Protective Measures Problem 1930 1969
Device Operational Issue 1804 1804
Failure to Power Up 1787 1787
Failure of Device to Self-Test 1733 1733
Display or Visual Feedback Problem 1494 1494
Degraded 1335 1335
Failure to Run on Battery 1280 1280
Electrical /Electronic Property Problem 1192 1192
Power Problem 1097 1139
No Flow 927 927
Incorrect Or Inadequate Test Results 906 906
Unexpected Shutdown 851 851
Infusion or Flow Problem 849 849
Leak/Splash 781 781
Failure to Deliver 741 741
Calibration Problem 727 727
Insufficient Information 713 713
Pressure Problem 686 686
Improper Flow or Infusion 636 636
Device Alarm System 629 629
Contamination 589 589
Therapeutic or Diagnostic Output Failure 551 551
Application Program Problem 522 522
Incorrect, Inadequate or Imprecise Result or Readings 515 515
Gas Output Problem 476 476
Appropriate Term/Code Not Available 460 460
Adverse Event Without Identified Device or Use Problem 436 436
Inadequate User Interface 424 428
Erratic or Intermittent Display 409 409
Loss of Power 399 399
Decrease in Pressure 397 397
Defective Component 378 378
Tidal Volume Fluctuations 378 378
Charging Problem 368 368
Communication or Transmission Problem 348 348
Noise, Audible 329 329
Inaccurate Delivery 298 298
Break 288 288
Use of Device Problem 287 287
Defective Device 270 270
Inappropriate or Unexpected Reset 213 214
Device Stops Intermittently 211 211
No Audible Alarm 204 204
Computer Software Problem 201 201
Complete Loss of Power 201 201
Reset Problem 196 196
Aborted Charge 195 195
Temperature Problem 188 188
Defective Alarm 186 186
Gas/Air Leak 184 184
Premature Discharge of Battery 183 183
Connection Problem 176 176
Volume Accuracy Problem 164 164
Smoking 157 157
Device Sensing Problem 154 154
Contamination /Decontamination Problem 153 153
Increase in Pressure 151 151
Failure to Cycle 141 141
No Pressure 141 141
Disconnection 122 122
Detachment of Device or Device Component 112 112
Occlusion Within Device 107 107
Overheating of Device 97 97
Thermal Decomposition of Device 95 95
Computer Operating System Problem 92 92
Low Readings 87 87
Ventilation Problem in Device Environment 81 81
Fracture 75 75
Operating System Becomes Nonfunctional 73 73
Device Emits Odor 70 70
Obstruction of Flow 69 69
Failure to Read Input Signal 66 66
Self-Activation or Keying 64 64
High Readings 63 63
Unexpected Therapeutic Results 61 61
Suction Problem 57 57
Unintended Collision 51 51
Image Display Error/Artifact 50 50
Fire 50 50
Tactile Prompts/Feedback 50 50
Data Problem 47 47
Human-Device Interface Problem 46 46
Loose or Intermittent Connection 45 45
Excess Flow or Over-Infusion 45 45
Poor Quality Image 44 44
Failure to Sense 44 44
Activation Problem 44 44
Application Interface Becomes Non-Functional Or Program Exits Abnormally 43 43
False Alarm 42 42

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 25246 25246
No Patient Involvement 20332 20332
No Consequences Or Impact To Patient 16619 17020
No Known Impact Or Consequence To Patient 3033 3034
No Information 1889 1889
Insufficient Information 1302 1302
No Code Available 1081 1081
Low Oxygen Saturation 720 721
Death 397 397
Dyspnea 147 147
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 107 107
Headache 105 105
Cardiac Arrest 100 100
Cough 67 67
Respiratory Distress 61 61
Bradycardia 60 60
Sore Throat 58 58
Respiratory Tract Infection 57 57
Hypoxia 53 53
Unspecified Respiratory Problem 44 44
Cyanosis 39 39
Pneumothorax 38 38
Respiratory Failure 31 31
Nausea 30 30
Dizziness 28 28
Respiratory Arrest 28 28
Patient Problem/Medical Problem 27 27
Hypoventilation 27 27
Cardiopulmonary Arrest 27 27
Low Blood Pressure/ Hypotension 25 25
Injury 22 22
Pneumonia 20 20
Increased Respiratory Rate 15 15
Discomfort 14 14
Chest Pain 14 14
Apnea 14 14
Respiratory Insufficiency 14 14
Unspecified Eye / Vision Problem 14 14
Cancer 14 14
Unspecified Infection 13 13
Respiratory Acidosis 13 13
Tachycardia 12 12
Vomiting 11 11
Chronic Obstructive Pulmonary Disease (COPD) 11 11
Loss of consciousness 11 11
Burn(s) 11 11
Dry Eye(s) 8 8
Anxiety 8 8
Unspecified Kidney or Urinary Problem 8 8
Skin Inflammation/ Irritation 8 8
Epistaxis 7 7
Heart Failure/Congestive Heart Failure 7 7
Pain 7 7
Abnormal Blood Gases 6 6
Coma 6 6
Urinary Retention 6 6
Rash 6 6
Bowel Perforation 6 6
Convulsion/Seizure 5 5
Swelling/ Edema 5 5
Aspiration/Inhalation 5 5
Fatigue 5 5
Inflammation 5 5
High Blood Pressure/ Hypertension 5 5
Hyperventilation 5 5
Hypersensitivity/Allergic reaction 4 4
Perforation 4 4
Necrosis 4 4
Pulmonary Emphysema 4 4
Asthma 4 4
Bacterial Infection 4 4
Renal Failure 4 4
Brain Injury 4 4
Dry Mouth 4 4
Wheezing 4 4
Speech Disorder 4 4
Abdominal Distention 4 4
Electric Shock 4 4
Confusion/ Disorientation 3 3
Foreign Body In Patient 3 3
Thrombosis/Thrombus 3 3
Unspecified Heart Problem 3 3
Nodule 3 3
Unspecified Gastrointestinal Problem 3 3
Sinus Perforation 3 3
Burning Sensation 3 3
Therapeutic Effects, Unexpected 3 3
Respiratory Alkalosis 3 3
Decreased Respiratory Rate 3 3
Choking 3 3
Stacking Breaths 3 3
Adult Respiratory Distress Syndrome 3 3
Airway Obstruction 3 3
Pulmonary Embolism 2 2
Atrial Fibrillation 2 2
Arrhythmia 2 2
Bronchitis 2 2
Bruise/Contusion 2 2
Stroke/CVA 2 2
Eye Injury 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Breas Medical, Inc. II Apr-15-2022
2 COVIDIEN LLC I Dec-18-2018
3 Covidien LLC II Mar-27-2018
4 Covidien Llc II Nov-06-2020
5 Covidien, LP I Apr-25-2022
6 Covidien, LP I Dec-09-2021
7 Datex-Ohmeda, Inc. II Aug-08-2018
8 Datex-Ohmeda, Inc. II Jun-01-2018
9 Del Mar Reynolds Medical, Ltd. II Mar-14-2017
10 Draeger Medical, Inc. II Apr-04-2022
11 Draeger Medical, Inc. II Oct-14-2021
12 Draeger Medical, Inc. II May-28-2021
13 Draeger Medical, Inc. II May-29-2018
14 GE Healthcare, LLC I Jun-06-2022
15 GE Healthcare, LLC II Aug-24-2020
16 GE Healthcare, LLC II Dec-17-2019
17 GE Healthcare, LLC I Nov-30-2018
18 Getinge Group Logistics America, LLC II Oct-09-2020
19 Getinge Usa Sales Inc II Aug-24-2022
20 Getinge Usa Sales Inc I Aug-22-2022
21 Hamilton Medical AG II Nov-18-2022
22 Hamilton Medical AG I Aug-19-2022
23 Hamilton Medical AG I Jul-11-2019
24 Hamilton Medical AG II Aug-14-2018
25 Hamilton Medical AG II Apr-12-2018
26 Hill-Rom Manufacturing, Inc. II Nov-24-2020
27 NIHON KOHDEN ORANGEMED, INC II Sep-08-2021
28 Newport Medical Instruments Inc I Apr-10-2017
29 Philips Respironics, Inc. I Mar-18-2022
30 Philips Respironics, Inc. I Jan-22-2022
31 Philips Respironics, Inc. II Aug-13-2021
32 Philips Respironics, Inc. I Jul-15-2021
33 Philips Respironics, Inc. I Feb-15-2020
34 Spacelabs Healthcare, Ltd. I Aug-10-2018
35 Ventec Life Systems, Inc. II Jun-21-2021
36 Vyaire Medical I Feb-16-2022
37 Vyaire Medical II Mar-04-2020
38 ZOLL Medical Corporation II Mar-01-2018
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