Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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, 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
  1.  K162738  Puritan Bennett 980 Ventilator System
COVIDIEN, LLC
  SUBSTANTIALLY EQUIVALENT 1
DATEX-OHMEDA, INC.
  SUBSTANTIALLY EQUIVALENT 1
DRAEGERWERK AG & CO KGAA
  SUBSTANTIALLY EQUIVALENT 1
DRAEGERWERK AG & CO. KGAA
  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 3
NIHON KOHDEN ORANGEMED, LLC
  SUBSTANTIALLY EQUIVALENT 1
ORIGIN MEDICAL DEVICES
  SUBSTANTIALLY EQUIVALENT 1
RESMED LTD
  SUBSTANTIALLY EQUIVALENT 1
RESPIRONICS INC.
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
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 9849 9849
2019 9100 9502
2020 11096 11096
2021 13322 13322
2022 15976 15976
2023 24955 24955
2024 6744 6744

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 12379 12379
Output Problem 9389 9389
Circuit Failure 7049 7049
Device Displays Incorrect Message 6203 6203
No Display/Image 5256 5256
Battery Problem 4971 5005
Failure to Recalibrate 4762 4762
Failure to Run on Battery 3910 3910
Defective Component 3799 3799
Device Operates Differently Than Expected 3745 3745
Failure to Calibrate 3516 3782
Electrical /Electronic Property Problem 3039 3039
Failure to Charge 2534 2550
Failure to Power Up 2512 2512
Display or Visual Feedback Problem 2314 2314
Failure of Device to Self-Test 2054 2054
Protective Measures Problem 2050 2089
Gas/Air Leak 2002 2002
Device Inoperable 1968 1968
Device Operational Issue 1804 1804
Improper Flow or Infusion 1732 1732
Degraded 1593 1593
Power Problem 1540 1582
Insufficient Information 1375 1375
No Flow 1330 1330
Contamination 1319 1319
Unexpected Shutdown 1292 1292
Leak/Splash 1278 1278
Infusion or Flow Problem 1209 1209
Failure to Deliver 1149 1149
Decrease in Pressure 1012 1012
Pressure Problem 942 942
Incorrect Or Inadequate Test Results 906 906
Calibration Problem 902 902
Gas Output Problem 788 788
Insufficient Flow or Under Infusion 782 782
Device Alarm System 720 720
Adverse Event Without Identified Device or Use Problem 695 695
Therapeutic or Diagnostic Output Failure 663 663
Application Program Problem 595 595
Appropriate Term/Code Not Available 556 556
Incorrect, Inadequate or Imprecise Result or Readings 549 549
Complete Loss of Power 517 517
Communication or Transmission Problem 502 502
Computer Software Problem 473 473
Erratic or Intermittent Display 473 473
Tidal Volume Fluctuations 471 471
Charging Problem 465 465
Inadequate User Interface 445 449
Loss of Power 405 405
Use of Device Problem 379 379
Break 378 378
Noise, Audible 377 377
Connection Problem 370 370
Inaccurate Delivery 345 345
Increase in Pressure 293 293
Defective Device 287 287
No Audible Alarm 259 259
Device Sensing Problem 247 247
Excess Flow or Over-Infusion 241 241
Inappropriate or Unexpected Reset 238 239
Defective Alarm 235 235
Reset Problem 235 235
Loose or Intermittent Connection 229 229
Premature Discharge of Battery 217 217
Temperature Problem 213 213
Contamination /Decontamination Problem 212 212
Device Stops Intermittently 211 211
Peeled/Delaminated 211 211
Smoking 206 206
Disconnection 202 202
Alarm Not Visible 197 197
Volume Accuracy Problem 197 197
Aborted Charge 196 196
False Positive Result 194 194
Obstruction of Flow 185 185
Medical Gas Supply Problem 183 183
Low Readings 170 170
Detachment of Device or Device Component 166 166
Fracture 160 160
No Pressure 160 160
Failure to Conduct 159 159
Failure to Cycle 149 149
Suction Problem 136 136
Unexpected Therapeutic Results 135 135
Key or Button Unresponsive/not Working 134 134
Computer Operating System Problem 131 131
Failure to Read Input Signal 127 127
Mechanical Jam 126 126
Overheating of Device 117 117
No Visual Prompts/Feedback 115 115
Inaccurate Flow Rate 111 111
Incomplete or Inadequate Connection 108 108
Occlusion Within Device 107 107
Thermal Decomposition of Device 100 100
Electrical Shorting 100 100
Intermittent Continuity 96 96
Failure to Sense 95 95
No Apparent Adverse Event 92 92
Device Handling Problem 90 90

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 58749 58749
No Patient Involvement 20332 20332
No Consequences Or Impact To Patient 16618 17019
No Known Impact Or Consequence To Patient 3033 3034
No Information 1889 1889
Insufficient Information 1633 1633
No Code Available 1081 1081
Low Oxygen Saturation 1035 1036
Death 397 397
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 255 255
Unspecified Respiratory Problem 229 229
Dyspnea 224 224
Headache 169 169
Respiratory Failure 152 152
Cardiac Arrest 144 144
Respiratory Insufficiency 121 121
Respiratory Tract Infection 86 86
Cough 83 83
Hypoxia 81 81
Ventilator Dependent 78 78
Bradycardia 77 77
Sore Throat 76 76
Dizziness 72 72
Respiratory Distress 61 61
Pneumothorax 55 55
Cyanosis 52 52
Nausea 47 47
Respiratory Arrest 40 40
Cancer 35 35
Hypoventilation 35 35
Low Blood Pressure/ Hypotension 33 33
Pneumonia 31 31
Cardiopulmonary Arrest 27 27
Unspecified Kidney or Urinary Problem 27 27
Patient Problem/Medical Problem 27 27
Skin Inflammation/ Irritation 26 26
Asthma 26 26
Vomiting 25 25
Discomfort 25 25
Loss of consciousness 25 25
Apnea 24 24
Increased Respiratory Rate 24 24
Injury 22 22
Tachycardia 21 21
Respiratory Acidosis 20 20
Chronic Obstructive Pulmonary Disease (COPD) 19 19
Hypersensitivity/Allergic reaction 19 19
Chest Pain 18 18
Inflammation 17 17
Unspecified Infection 16 16
Unspecified Eye / Vision Problem 15 15
Unspecified Heart Problem 15 15
Burn(s) 13 13
Heart Failure/Congestive Heart Failure 12 12
Epistaxis 11 11
Unspecified Hepatic or Biliary Problem 11 11
Abnormal Blood Gases 11 11
Hyperventilation 11 11
Anxiety 11 11
Nodule 10 10
Swelling/ Edema 8 8
Renal Failure 8 8
High Blood Pressure/ Hypertension 8 8
Fatigue 8 8
Stroke/CVA 8 8
Dry Eye(s) 8 8
Pain 7 7
Rash 7 7
Coma 7 7
Urinary Retention 6 6
Liver Damage/Dysfunction 6 6
Airway Obstruction 6 6
Aspiration/Inhalation 6 6
Convulsion/Seizure 6 6
Bowel Perforation 6 6
Sleep Dysfunction 5 5
Confusion/ Disorientation 5 5
Partial thickness (Second Degree) Burn 5 5
Thrombosis/Thrombus 5 5
Adult Respiratory Distress Syndrome 5 5
Pulmonary Emphysema 5 5
Necrosis 5 5
Fever 5 5
Burning Sensation 5 5
Sinus Perforation 5 5
Distress 4 4
Overinflation of Lung 4 4
Decreased Respiratory Rate 4 4
Brain Injury 4 4
Hemoptysis 4 4
Hemorrhage/Bleeding 4 4
Perforation 4 4
Encephalopathy 4 4
Fall 4 4
Bacterial Infection 4 4
Asystole 4 4
Cardiovascular Insufficiency 4 4
Wheezing 4 4
Dry Mouth 4 4
Speech Disorder 4 4

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corporation I Feb-24-2023
2 Breas Medical, Inc. II Apr-15-2022
3 COVIDIEN LLC I Dec-18-2018
4 Covidien LLC II Mar-27-2018
5 Covidien Llc II Nov-06-2020
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. I Aug-18-2023
11 Draeger Medical, Inc. I Jul-08-2023
12 Draeger Medical, Inc. I Feb-24-2023
13 Draeger Medical, Inc. II Apr-04-2022
14 Draeger Medical, Inc. II Oct-14-2021
15 Draeger Medical, Inc. II May-28-2021
16 Draeger Medical, Inc. II May-29-2018
17 GE Healthcare, LLC I Jun-06-2022
18 GE Healthcare, LLC II Aug-24-2020
19 GE Healthcare, LLC II Dec-17-2019
20 GE Healthcare, LLC I Nov-30-2018
21 Getinge Group Logistics America, LLC II Oct-09-2020
22 Getinge Usa Sales Inc II Aug-24-2022
23 Getinge Usa Sales Inc I Aug-22-2022
24 Hamilton Medical AG II Apr-25-2023
25 Hamilton Medical AG II Nov-18-2022
26 Hamilton Medical AG I Aug-19-2022
27 Hamilton Medical AG I Jul-11-2019
28 Hamilton Medical AG II Aug-14-2018
29 Hamilton Medical AG II Apr-12-2018
30 Hamilton Medical, Inc. I Sep-20-2023
31 Hamilton Medical, Inc. I Jul-21-2023
32 Hill-Rom Manufacturing, Inc. II Nov-24-2020
33 Medtronic formerly Covidien I Apr-25-2022
34 NIHON KOHDEN ORANGEMED, INC II Sep-08-2021
35 Newport Medical Instruments Inc I Apr-10-2017
36 Percussionaire Corporation I Jan-17-2024
37 Percussionaire Corporation I Jan-17-2024
38 Percussionaire Corporation II Nov-07-2023
39 Philips Respironics, Inc. I Apr-17-2024
40 Philips Respironics, Inc. II Jan-04-2024
41 Philips Respironics, Inc. II Jul-07-2023
42 Philips Respironics, Inc. I Jun-02-2023
43 Philips Respironics, Inc. I Apr-03-2023
44 Philips Respironics, Inc. I Jan-06-2023
45 Philips Respironics, Inc. I Mar-18-2022
46 Philips Respironics, Inc. I Jan-22-2022
47 Philips Respironics, Inc. II Aug-13-2021
48 Philips Respironics, Inc. I Jul-15-2021
49 Philips Respironics, Inc. I Feb-15-2020
50 ResMed Ltd. I Oct-23-2023
51 Spacelabs Healthcare, Ltd. I Aug-10-2018
52 Ventec Life Systems, Inc. I Feb-23-2024
53 Ventec Life Systems, Inc. II Jun-21-2021
54 Vyaire Medical II Jun-15-2023
55 Vyaire Medical I Feb-16-2022
56 Vyaire Medical II Mar-04-2020
57 ZOLL Medical Corporation II Mar-01-2018
-
-