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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
Regulation Description Continuous ventilator.
Product CodeCBK
Regulation Number 868.5895
Device Class 2


Premarket Reviews
ManufacturerDecision
CORVENT MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
  1.  K241135  RESPOND(R) Ventilator
COVIDIEN, LLC
  SUBSTANTIALLY EQUIVALENT 1
DATEX-OHMEDA, INC.
  SUBSTANTIALLY EQUIVALENT 1
DIMAR S.P.A
  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
FLIGHT MEDICAL INNOVATIONS LTD.
  SUBSTANTIALLY EQUIVALENT 1
HAMILTON MEDICAL AG
  SUBSTANTIALLY EQUIVALENT 4
HAMITON MEDICAL AG
  SUBSTANTIALLY EQUIVALENT 1
IMTMEDICAL AG
  SUBSTANTIALLY EQUIVALENT 1
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
NIHON KOHDEN ORANGEMED, LLC
  SUBSTANTIALLY EQUIVALENT 1
ORIGIN MEDICAL DEVICES
  SUBSTANTIALLY EQUIVALENT 1
RESPIRONICS INC.
  SUBSTANTIALLY EQUIVALENT 3
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
SLEEPNET CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
VENTIS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
VYAIRE MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 1
ZOLL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 9100 9502
2020 11096 11096
2021 13322 13322
2022 15976 15976
2023 24955 24955
2024 20336 20336
2025 4207 4207

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 12567 12567
Output Problem 11307 11307
Circuit Failure 7129 7129
Battery Problem 5755 5789
Failure to Recalibrate 4802 4802
Electrical /Electronic Property Problem 4567 4567
Failure to Run on Battery 4425 4425
No Display/Image 4377 4377
Defective Component 3911 3911
Failure to Power Up 2824 2824
Gas/Air Leak 2633 2633
Failure of Device to Self-Test 2527 2527
Display or Visual Feedback Problem 2473 2473
Failure to Calibrate 2365 2631
Degraded 2321 2321
Failure to Charge 2213 2229
Improper Flow or Infusion 1970 1970
Insufficient Flow or Under Infusion 1940 1940
Protective Measures Problem 1839 1878
Unexpected Shutdown 1739 1739
Insufficient Information 1586 1586
Contamination 1484 1484
Power Problem 1439 1481
Infusion or Flow Problem 1379 1379
No Flow 1295 1295
Failure to Deliver 1262 1262
Decrease in Pressure 1110 1110
Leak/Splash 1074 1074
Gas Output Problem 1021 1021
Device Displays Incorrect Message 940 940
Pressure Problem 869 869
Therapeutic or Diagnostic Output Failure 788 788
Calibration Problem 723 723
Complete Loss of Power 700 700
Adverse Event Without Identified Device or Use Problem 584 584
Application Program Problem 561 561
Incorrect, Inadequate or Imprecise Result or Readings 492 492
Computer Software Problem 491 491
Inadequate User Interface 451 455
Device Alarm System 437 437
Communication or Transmission Problem 413 413
Connection Problem 405 405
Use of Device Problem 385 385
Increase in Pressure 327 327
Tidal Volume Fluctuations 322 322
Loose or Intermittent Connection 271 271
Unexpected Therapeutic Results 256 256
False Positive Result 256 256
No Apparent Adverse Event 239 239
Fracture 235 235

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 75489 75489
No Patient Involvement 8546 8546
No Consequences Or Impact To Patient 8083 8484
Insufficient Information 1891 1891
Low Oxygen Saturation 1044 1044
No Known Impact Or Consequence To Patient 1036 1037
No Information 865 865
Unspecified Respiratory Problem 538 538
Headache 358 358
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 279 279
Dizziness 257 257
Dyspnea 251 251
Death 184 184
Respiratory Failure 172 172
Asthma 166 166
Cancer 159 159
Cardiac Arrest 147 147
Respiratory Insufficiency 132 132
Unspecified Kidney or Urinary Problem 131 131
Respiratory Tract Infection 128 128
Nausea 115 115
Skin Inflammation/ Irritation 100 100
Vomiting 93 93
Cough 90 90
Inflammation 85 85
Hypoxia 84 84
Ventilator Dependent 83 83
Bradycardia 78 78
Sore Throat 76 76
Hypersensitivity/Allergic reaction 73 73
No Code Available 66 66
Respiratory Arrest 60 60
Unspecified Heart Problem 59 59
Pneumothorax 55 55
Pneumonia 51 51
Chronic Obstructive Pulmonary Disease (COPD) 46 46
Cyanosis 43 43
Unspecified Hepatic or Biliary Problem 35 35
Hypoventilation 32 32
Discomfort 29 29
Heart Failure/Congestive Heart Failure 28 28
Low Blood Pressure/ Hypotension 27 27
Increased Respiratory Rate 26 26
Apnea 26 26
Loss of consciousness 24 24
Tachycardia 23 23
Chest Pain 21 21
Respiratory Distress 20 20
Patient Problem/Medical Problem 18 18
Unspecified Eye / Vision Problem 18 18

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corporation I Jan-16-2025
2 Baxter Healthcare Corporation I Oct-22-2024
3 Baxter Healthcare Corporation I Jun-26-2024
4 Baxter Healthcare Corporation I Feb-24-2023
5 Breas Medical, Inc. II Apr-15-2022
6 Covidien I Aug-02-2024
7 Covidien Llc I Dec-09-2021
8 Covidien Llc II Nov-06-2020
9 Draeger Medical, Inc. I Aug-18-2023
10 Draeger Medical, Inc. I Jul-08-2023
11 Draeger Medical, Inc. I Feb-24-2023
12 Draeger Medical, Inc. II Apr-04-2022
13 Draeger Medical, Inc. II Oct-14-2021
14 Draeger Medical, Inc. II May-28-2021
15 GE Healthcare, LLC I Jun-06-2022
16 GE Healthcare, LLC II Aug-24-2020
17 GE Healthcare, LLC II Dec-17-2019
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 I Jun-18-2024
22 Hamilton Medical AG II Apr-25-2023
23 Hamilton Medical AG II Nov-18-2022
24 Hamilton Medical AG I Aug-19-2022
25 Hamilton Medical AG I Jul-11-2019
26 Hamilton Medical, Inc. I Sep-20-2023
27 Hamilton Medical, Inc. I Jul-21-2023
28 Hill-Rom Manufacturing, Inc. II Nov-24-2020
29 Medtronic formerly Covidien I Apr-25-2022
30 NIHON KOHDEN ORANGEMED, INC II Sep-08-2021
31 Percussionaire Corporation I Jan-23-2025
32 Percussionaire Corporation I Jan-17-2024
33 Percussionaire Corporation I Jan-17-2024
34 Percussionaire Corporation II Nov-07-2023
35 Philips Respironics, Inc. I Nov-13-2024
36 Philips Respironics, Inc. I Sep-05-2024
37 Philips Respironics, Inc. I Apr-17-2024
38 Philips Respironics, Inc. II Jan-04-2024
39 Philips Respironics, Inc. II Jul-07-2023
40 Philips Respironics, Inc. I Jun-02-2023
41 Philips Respironics, Inc. I Apr-03-2023
42 Philips Respironics, Inc. I Jan-06-2023
43 Philips Respironics, Inc. I Mar-18-2022
44 Philips Respironics, Inc. I Jan-22-2022
45 Philips Respironics, Inc. II Aug-13-2021
46 Philips Respironics, Inc. I Jul-15-2021
47 Philips Respironics, Inc. I Feb-15-2020
48 ResMed Ltd. I Oct-23-2023
49 Ventec Life Systems, Inc. I Feb-26-2025
50 Ventec Life Systems, Inc. I Feb-23-2024
51 Ventec Life Systems, Inc. II Jun-21-2021
52 Vyaire Medical II Jun-15-2023
53 Vyaire Medical I Feb-16-2022
54 Vyaire Medical II Mar-04-2020
55 ZOLL Medical Corporation I Jun-20-2024
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