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
AIRON CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
BIO-MED DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1
BREATHE TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 2
CARDINAL HEALTH 207, INC.
  SUBSTANTIALLY EQUIVALENT 1
CAREFUSION
  SUBSTANTIALLY EQUIVALENT 2
COSMED S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 2
COVIDIEN LP
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT INC.
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT, INC.
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN, LLC
  SUBSTANTIALLY EQUIVALENT 1
DATEX-OHMEDA
  SUBSTANTIALLY EQUIVALENT 1
DATEX-OHMEDA INC., A DIVISION OF INSTRUMENTARIUM C
  SUBSTANTIALLY EQUIVALENT 1
DATEX-OHMEDA, INC.
  SUBSTANTIALLY EQUIVALENT 3
DRAEGER MEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 1
DRAEGER MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
DRAEGERWERK AG & CO KGAA
  SUBSTANTIALLY EQUIVALENT 1
DRAEGERWERK AG & CO. KGAA
  SUBSTANTIALLY EQUIVALENT 2
DRAGER MEDICAL AG & CO. KGAA
  SUBSTANTIALLY EQUIVALENT 1
DRAGERWERK AG & CO. KGAA
  SUBSTANTIALLY EQUIVALENT 1
EVENT MEDICAL LTD
  SUBSTANTIALLY EQUIVALENT 1
EVENT MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
FISHER & PAYKEL HEALTHCARE LTD
  SUBSTANTIALLY EQUIVALENT 1
FISHER & PAYKEL HEALTHCARE, LTD.
  SUBSTANTIALLY EQUIVALENT 1
FISHER AND PAYKEL HEALTHCARE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
FLIGHT MEDICAL INNOVATIONS LTD.
  SUBSTANTIALLY EQUIVALENT 4
FLIGHT MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
HAMILTON MEDICAL AG
  SUBSTANTIALLY EQUIVALENT 18
HAMITON MEDICAL AG
  SUBSTANTIALLY EQUIVALENT 1
HSINER CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
IMPACT INSTRUMENTATION, INC.
  SUBSTANTIALLY EQUIVALENT 3
IMTMEDICAL AG
  SUBSTANTIALLY EQUIVALENT 2
INOVYTECH MEDICAL SOLUTIONS LTD.
  SUBSTANTIALLY EQUIVALENT 1
LEVEL-5, INC.
  SUBSTANTIALLY EQUIVALENT 1
MAQUET CRITICA CARE AB
  SUBSTANTIALLY EQUIVALENT 1
MAQUET CRITICAL CARE AB
  SUBSTANTIALLY EQUIVALENT 4
  1.  K123149  SERVO-I VENTILATOR SYSTEM
  2.  K151814  SERVO-U Ventilator System, SERVO-n Ventilator Syst ...
  3.  K180098  SERVO-U Ventilator System version 2.1; SERVO-n Ven ...
  4.  K201874  Servo-u Ventilator System 4.1, Servo-n Ventilator ...
NEWPORT MEDICAL INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 4
NIHON KOHDEN ORANGEMED, INC.
  SUBSTANTIALLY EQUIVALENT 3
NIHON KOHDEN ORANGEMED, LLC
  SUBSTANTIALLY EQUIVALENT 1
OCONNELL REGULATORY CONSULTANTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ORICARE, INC.
  SUBSTANTIALLY EQUIVALENT 1
ORIGIN MEDICAL DEVICES
  SUBSTANTIALLY EQUIVALENT 1
PAN-AMERICA HYPERBARICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
PROVIDENCE GLOBAL MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
PULMONETIC SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
RESMED LTD
  SUBSTANTIALLY EQUIVALENT 1
RESMED LTD.
  SUBSTANTIALLY EQUIVALENT 3
RESPIRONICS CALIFORNIA, INC.
  SUBSTANTIALLY EQUIVALENT 3
RESPIRONICS INC.
  SUBSTANTIALLY EQUIVALENT 2
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP
  SUBSTANTIALLY EQUIVALENT 2
RESPIRONICS, INC.
  SUBSTANTIALLY EQUIVALENT 6
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
SLEEPNET CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SPACELABS HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 2
SPACELABS HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 1
TECME S.A.
  SUBSTANTIALLY EQUIVALENT 2
VENTEC LIFE SYSTEMS, INC
  SUBSTANTIALLY EQUIVALENT 1
VERSAMED MEDICAL SYSTEMS LTD.
  SUBSTANTIALLY EQUIVALENT 2
VERSAMED MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
VYAIRE MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 1
ZOLL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 7596 7596
2015 11874 11874
2016 16056 16056
2017 14451 14451
2018 9849 9849
2019 9100 9502
2020 11096 11096
2021 13322 13322
2022 15976 15976
2023 24956 24956
2024 8134 8134

Device Problems MDRs with this Device Problem Events in those MDRs
Device Displays Incorrect Message 15343 15343
Mechanical Problem 12605 12605
Device Operates Differently Than Expected 9862 9862
Output Problem 9600 9600
No Display/Image 8391 8391
Circuit Failure 7150 7150
Battery Problem 6414 6448
Device Inoperable 6042 6042
Failure to Recalibrate 4824 4824
Failure to Charge 4588 4604
Failure to Run on Battery 3948 3948
Defective Component 3909 3909
Failure to Calibrate 3848 4114
Failure to Power Up 3668 3668
Electrical /Electronic Property Problem 3404 3404
Incorrect Or Inadequate Test Results 2611 2611
Display or Visual Feedback Problem 2520 2520
Failure of Device to Self-Test 2357 2357
Device Operational Issue 2347 2347
Gas/Air Leak 2111 2111
Appropriate Term/Code Not Available 2087 2087
Protective Measures Problem 2061 2100
Improper Flow or Infusion 1884 1884
Power Problem 1817 1859
Degraded 1717 1717
Leak/Splash 1561 1561
Insufficient Information 1523 1523
No Flow 1448 1448
Device Alarm System 1424 1424
Contamination 1418 1418
Failure to Deliver 1415 1415
Unexpected Shutdown 1335 1335
Infusion or Flow Problem 1319 1319
Pressure Problem 1187 1187
Loss of Power 1158 1158
Erratic or Intermittent Display 1157 1157
Adverse Event Without Identified Device or Use Problem 1152 1152
Calibration Problem 1132 1132
Decrease in Pressure 1079 1079
Insufficient Flow or Under Infusion 881 881
Break 860 860
Gas Output Problem 848 848
Communication or Transmission Problem 828 828
Tidal Volume Fluctuations 724 724
Inaccurate Delivery 697 697
Therapeutic or Diagnostic Output Failure 688 688
Charging Problem 674 674
Noise, Audible 632 632
Application Program Problem 616 616
Failure to Cycle 599 599
Incorrect, Inadequate or Imprecise Result or Readings 564 564
Complete Loss of Power 542 542
Device Stops Intermittently 514 514
Computer Software Problem 487 487
Connection Problem 484 484
No Audible Alarm 465 465
Inadequate User Interface 454 458
Thermal Decomposition of Device 452 452
Use of Device Problem 420 420
Application Interface Becomes Non-Functional Or Program Exits Abnormally 405 405
Increase in Pressure 394 394
Inappropriate or Unexpected Reset 372 373
Self-Activation or Keying 347 347
Volume Accuracy Problem 340 340
Device Sensing Problem 336 336
Image Display Error/Artifact 326 326
Defective Device 320 320
Disconnection 312 312
Reset Problem 300 300
Premature Discharge of Battery 296 296
Computer Operating System Problem 292 292
Smoking 284 284
Loose or Intermittent Connection 276 276
Excess Flow or Over-Infusion 259 259
Defective Alarm 258 258
Device Maintenance Issue 248 248
Occlusion Within Device 247 247
Temperature Problem 242 242
Poor Quality Image 217 217
Alarm Not Visible 217 217
Contamination /Decontamination Problem 214 214
Aborted Charge 213 213
Peeled/Delaminated 211 211
False Positive Result 203 203
Medical Gas Supply Problem 199 199
Obstruction of Flow 197 197
No Pressure 186 186
Low Readings 183 183
Device Emits Odor 179 179
Ventilation Problem in Device Environment 174 174
Detachment of Device or Device Component 173 173
Fracture 168 168
Suction Problem 165 165
Overheating of Device 163 163
Failure to Conduct 159 159
Crack 150 150
Unexpected Therapeutic Results 147 147
Operating System Becomes Nonfunctional 145 145
Mechanical Jam 143 143
Key or Button Unresponsive/not Working 137 137

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 60083 60083
No Patient Involvement 37609 37610
No Consequences Or Impact To Patient 25166 25567
No Known Impact Or Consequence To Patient 10951 10953
No Information 2951 2951
Insufficient Information 1671 1671
Low Oxygen Saturation 1300 1301
No Code Available 1161 1161
Death 725 725
Unspecified Respiratory Problem 270 270
Dyspnea 265 265
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 259 259
Headache 194 194
Cardiac Arrest 190 190
Respiratory Failure 171 171
Respiratory Insufficiency 121 121
Respiratory Distress 120 120
Hypoxia 107 107
Bradycardia 106 106
Dizziness 98 98
Respiratory Tract Infection 91 91
Cough 83 83
Ventilator Dependent 81 81
Cyanosis 80 80
Sore Throat 76 76
Pneumothorax 72 72
Hypoventilation 55 55
Patient Problem/Medical Problem 52 52
Asthma 50 50
Nausea 50 50
Low Blood Pressure/ Hypotension 45 45
Cancer 43 43
Respiratory Arrest 43 43
Pneumonia 42 42
Apnea 41 41
Loss of consciousness 41 41
Injury 40 40
Unspecified Kidney or Urinary Problem 40 40
Cardiopulmonary Arrest 40 40
Vomiting 33 33
Skin Inflammation/ Irritation 33 33
Discomfort 33 33
Increased Respiratory Rate 33 33
Chronic Obstructive Pulmonary Disease (COPD) 30 30
Tachycardia 30 30
Inflammation 28 28
Hypersensitivity/Allergic reaction 27 27
Respiratory Acidosis 23 23
Chest Pain 21 21
Unspecified Heart Problem 18 18
Unspecified Infection 17 17
Abnormal Blood Gases 16 16
Heart Failure/Congestive Heart Failure 16 16
Unspecified Eye / Vision Problem 16 16
Burn(s) 15 15
Stroke/CVA 14 14
Anxiety 14 14
Unspecified Hepatic or Biliary Problem 14 14
Complaint, Ill-Defined 13 13
High Blood Pressure/ Hypertension 13 13
Hyperventilation 13 13
Urinary Retention 11 11
Pain 11 11
Epistaxis 11 11
Nodule 10 10
Bowel Perforation 10 10
Liver Damage/Dysfunction 10 10
Fatigue 10 10
Stacking Breaths 10 10
Pulmonary Dysfunction 9 9
Distress 9 9
Extubate 9 9
Decreased Respiratory Rate 9 9
Coma 8 8
Swelling/ Edema 8 8
Brain Injury 8 8
Renal Failure 8 8
Dry Eye(s) 8 8
Hemorrhage/Bleeding 7 7
Airway Obstruction 7 7
Aspiration/Inhalation 7 7
Burning Sensation 7 7
Perforation 7 7
Rash 7 7
Overinflation of Lung 7 7
Electric Shock 7 7
Lethargy 7 7
Sleep Dysfunction 6 6
Cognitive Changes 6 6
Confusion/ Disorientation 6 6
Foreign Body In Patient 6 6
Partial thickness (Second Degree) Burn 6 6
Convulsion/Seizure 6 6
Myocardial Infarction 6 6
Encephalopathy 6 6
Fever 6 6
Fall 6 6
Pulmonary Emphysema 5 5
Hemoptysis 5 5
Adult Respiratory Distress Syndrome 5 5

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corporation I Feb-24-2023
2 Biomed Devices II Jan-27-2011
3 Breas Medical, Inc. II Apr-15-2022
4 COVIDIEN LLC I Dec-18-2018
5 CareFusion 203, Inc. I Sep-19-2014
6 CareFusion 203, Inc. I Jul-16-2012
7 CareFusion 203, Inc. I Oct-26-2011
8 CareFusion 203, Inc. II Aug-10-2010
9 CareFusion 203, Inc. II Feb-25-2010
10 Carefusion 211 Inc I Jan-11-2012
11 Carefusion 211 Inc dba Carefusion I Jun-13-2016
12 Carefusion 211 Inc dba Carefusion I May-26-2015
13 Carefusion 211 Inc dba Carefusion I Sep-27-2013
14 Covidien I Jan-03-2014
15 Covidien LLC II Mar-27-2018
16 Covidien LP (formerly Nellcor Puritan Bennett Inc.) II Mar-17-2016
17 Covidien LP (formerly Nellcor Puritan Bennett Inc.) I Aug-14-2015
18 Covidien LP (formerly Nellcor Puritan Bennett Inc.) II Feb-05-2015
19 Covidien Llc II Nov-06-2020
20 Covidien, LP I Dec-09-2021
21 Datex-Ohmeda, Inc. II Aug-08-2018
22 Datex-Ohmeda, Inc. II Jun-01-2018
23 Del Mar Reynolds Medical, Ltd. II Mar-14-2017
24 Del Mar Reynolds Medical, Ltd. II Apr-20-2015
25 Del Mar Reynolds Medical, Ltd. I Apr-12-2014
26 Del Mar Reynolds Medical, Ltd. II Jul-19-2013
27 Del Mar Reynolds Medical, Ltd. I Mar-20-2013
28 Draeger Medical Systems, Inc. I Mar-28-2014
29 Draeger Medical Systems, Inc. II Oct-07-2010
30 Draeger Medical, Inc. I Aug-18-2023
31 Draeger Medical, Inc. I Jul-08-2023
32 Draeger Medical, Inc. I Feb-24-2023
33 Draeger Medical, Inc. II Apr-04-2022
34 Draeger Medical, Inc. II Oct-14-2021
35 Draeger Medical, Inc. II May-28-2021
36 Draeger Medical, Inc. II May-29-2018
37 Draeger Medical, Inc. I Aug-04-2016
38 Draeger Medical, Inc. I Feb-25-2016
39 Draeger Medical, Inc. I Feb-03-2016
40 Draeger Medical, Inc. I Dec-23-2015
41 Draeger Medical, Inc. I Aug-14-2015
42 Draeger Medical, Inc. II May-14-2009
43 Event Medical LTD I Nov-19-2015
44 Flight Medical Ltd. I Feb-21-2012
45 GE Healthcare II Mar-24-2015
46 GE Healthcare, LLC I Jun-06-2022
47 GE Healthcare, LLC II Aug-24-2020
48 GE Healthcare, LLC II Dec-17-2019
49 GE Healthcare, LLC I Nov-30-2018
50 GE Healthcare, LLC I Jun-17-2012
51 GE Medical Systems, LLC II Jan-21-2016
52 Getinge Group Logistics America, LLC II Oct-09-2020
53 Getinge Usa Sales Inc II Aug-24-2022
54 Getinge Usa Sales Inc I Aug-22-2022
55 Hamilton Medical AG II Apr-25-2023
56 Hamilton Medical AG II Nov-18-2022
57 Hamilton Medical AG I Aug-19-2022
58 Hamilton Medical AG I Jul-11-2019
59 Hamilton Medical AG II Aug-14-2018
60 Hamilton Medical AG II Apr-12-2018
61 Hamilton Medical Inc I Jan-31-2013
62 Hamilton Medical Inc II Mar-07-2012
63 Hamilton Medical Inc II Apr-08-2011
64 Hamilton Medical, Inc. I Sep-20-2023
65 Hamilton Medical, Inc. I Jul-21-2023
66 Hamilton Medical, Inc. II Nov-28-2016
67 Hamilton Medical, Inc. II May-09-2016
68 Hamilton Medical, Inc. I Nov-04-2015
69 Hamilton Medical, Inc. II Jul-10-2015
70 Hamilton Medical, Inc. II Nov-06-2013
71 Hill-Rom Manufacturing, Inc. II Nov-24-2020
72 Impact Instrumentation, Inc. III Aug-07-2012
73 Impact Instrumentation, Inc. II Aug-29-2011
74 MAQUET Inc. II Jan-05-2010
75 MAQUET Inc. II May-12-2009
76 MAQUET Inc. II Feb-03-2009
77 Maquet Cardiovascular Us Sales, Llc I Apr-26-2013
78 Maquet Inc. II Apr-03-2012
79 Maquet Inc. II Dec-02-2011
80 Maquet Inc. II Jun-23-2011
81 Medtronic formerly Covidien I Apr-25-2022
82 NIHON KOHDEN ORANGEMED, INC II Sep-08-2021
83 Nellcor Puritan Bennett Inc. (dba Covidien LP) I Dec-09-2014
84 Nellcor Puritan Bennett Inc. (dba Covidien LP) I Oct-28-2014
85 Nellcor Puritan Bennett Inc. (dba Covidien LP) II Jun-20-2014
86 Nellcor Puritan Bennett Inc. (dba Covidien LP) II Jun-17-2014
87 Nellcor Puritan Bennett Inc. (dba Covidien LP) II May-09-2014
88 Nellcor Puritan Bennett Inc. (dba Covidien LP) II Jan-24-2014
89 Newport Medical Instruments Inc I Apr-10-2017
90 Newport Medical Instruments Inc I Apr-14-2014
91 Newport Medical Instruments Inc I Apr-26-2013
92 Newport Medical Instruments Inc II Jun-08-2011
93 Newport Medical Instruments Inc II Jun-02-2011
94 Newport Medical Instruments Inc II May-27-2011
95 Newport Medical Instruments Inc II May-26-2011
96 Newport Medical Instruments Inc II May-26-2011
97 Newport Medical Instruments Inc II May-19-2010
98 Newport Medical Instruments Inc II Sep-04-2009
99 Percussionaire Corporation I Jan-17-2024
100 Percussionaire Corporation I Jan-17-2024
-
-