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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 LP
  SUBSTANTIALLY EQUIVALENT 1
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
FISHER AND PAYKEL HEALTHCARE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
FLIGHT MEDICAL INNOVATIONS LTD.
  SUBSTANTIALLY EQUIVALENT 1
HAMILTON MEDICAL AG
  SUBSTANTIALLY EQUIVALENT 6
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
RESMED LTD.
  SUBSTANTIALLY EQUIVALENT 1
RESPIRONICS INC.
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
SLEEPNET CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
VENTEC LIFE SYSTEMS, INC
  SUBSTANTIALLY EQUIVALENT 1
VENTIS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
VYAIRE MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 1
ZOLL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 16055 16055
2017 14451 14451
2018 9849 9849
2019 9100 9502
2020 11096 11096
2021 13322 13322
2022 15976 15976
2023 24957 24957
2024 13972 13972

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 12775 12775
Device Displays Incorrect Message 10390 10390
Output Problem 10362 10362
Circuit Failure 7375 7375
Device Operates Differently Than Expected 7171 7171
No Display/Image 7013 7013
Battery Problem 6062 6096
Failure to Recalibrate 4966 4966
Failure to Run on Battery 4101 4101
Defective Component 3924 3924
Failure to Calibrate 3897 4163
Electrical /Electronic Property Problem 3769 3769
Failure to Charge 3708 3724
Device Inoperable 3697 3697
Failure to Power Up 3105 3105
Display or Visual Feedback Problem 2446 2446
Gas/Air Leak 2327 2327
Device Operational Issue 2311 2311
Failure of Device to Self-Test 2292 2292
Degraded 2289 2289
Protective Measures Problem 2056 2095
Improper Flow or Infusion 1964 1964
Power Problem 1772 1814
Incorrect Or Inadequate Test Results 1637 1637
Insufficient Information 1561 1561
Unexpected Shutdown 1467 1467
No Flow 1456 1456
Contamination 1442 1442
Leak/Splash 1437 1437
Appropriate Term/Code Not Available 1369 1369
Infusion or Flow Problem 1334 1334
Failure to Deliver 1289 1289
Insufficient Flow or Under Infusion 1222 1222
Pressure Problem 1089 1089
Decrease in Pressure 1073 1073
Calibration Problem 1032 1032
Device Alarm System 984 984
Adverse Event Without Identified Device or Use Problem 980 980
Gas Output Problem 910 910
Erratic or Intermittent Display 786 786
Therapeutic or Diagnostic Output Failure 724 724
Loss of Power 682 682
Communication or Transmission Problem 649 649
Tidal Volume Fluctuations 623 623
Application Program Problem 617 617
Complete Loss of Power 616 616
Charging Problem 587 587
Break 571 571
Incorrect, Inadequate or Imprecise Result or Readings 565 565
Computer Software Problem 489 489

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 65321 65321
No Patient Involvement 28557 28557
No Consequences Or Impact To Patient 20634 21035
No Known Impact Or Consequence To Patient 5851 5852
No Information 2594 2594
Insufficient Information 1758 1758
Low Oxygen Saturation 1219 1220
No Code Available 1098 1098
Death 566 566
Unspecified Respiratory Problem 515 515
Headache 345 345
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 273 273
Dyspnea 249 249
Dizziness 247 247
Cardiac Arrest 173 173
Respiratory Failure 173 173
Asthma 162 162
Cancer 155 155
Unspecified Kidney or Urinary Problem 129 129
Respiratory Tract Infection 128 128
Respiratory Insufficiency 125 125
Nausea 111 111
Skin Inflammation/ Irritation 96 96
Hypoxia 96 96
Bradycardia 95 95
Vomiting 93 93
Cough 86 86
Respiratory Distress 83 83
Ventilator Dependent 82 82
Inflammation 81 81
Sore Throat 76 76
Hypersensitivity/Allergic reaction 71 71
Cyanosis 62 62
Pneumothorax 61 61
Unspecified Heart Problem 58 58
Pneumonia 53 53
Respiratory Arrest 48 48
Hypoventilation 46 46
Chronic Obstructive Pulmonary Disease (COPD) 44 44
Low Blood Pressure/ Hypotension 39 39
Patient Problem/Medical Problem 38 38
Cardiopulmonary Arrest 36 36
Unspecified Hepatic or Biliary Problem 34 34
Loss of consciousness 31 31
Injury 29 29
Apnea 28 28
Discomfort 28 28
Increased Respiratory Rate 26 26
Tachycardia 25 25
Heart Failure/Congestive Heart Failure 24 24

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corporation I Jun-26-2024
2 Baxter Healthcare Corporation I Feb-24-2023
3 Breas Medical, Inc. II Apr-15-2022
4 COVIDIEN LLC I Dec-18-2018
5 Carefusion 211 Inc dba Carefusion I Jun-13-2016
6 Covidien I Aug-02-2024
7 Covidien LLC II Mar-27-2018
8 Covidien LP (formerly Nellcor Puritan Bennett Inc.) II Mar-17-2016
9 Covidien Llc I Dec-09-2021
10 Covidien Llc II Nov-06-2020
11 Datex-Ohmeda, Inc. II Aug-08-2018
12 Datex-Ohmeda, Inc. II Jun-01-2018
13 Del Mar Reynolds Medical, Ltd. II Mar-14-2017
14 Draeger Medical, Inc. I Aug-18-2023
15 Draeger Medical, Inc. I Jul-08-2023
16 Draeger Medical, Inc. I Feb-24-2023
17 Draeger Medical, Inc. II Apr-04-2022
18 Draeger Medical, Inc. II Oct-14-2021
19 Draeger Medical, Inc. II May-28-2021
20 Draeger Medical, Inc. II May-29-2018
21 Draeger Medical, Inc. I Aug-04-2016
22 Draeger Medical, Inc. I Feb-25-2016
23 Draeger Medical, Inc. I Feb-03-2016
24 GE Healthcare, LLC I Jun-06-2022
25 GE Healthcare, LLC II Aug-24-2020
26 GE Healthcare, LLC II Dec-17-2019
27 GE Healthcare, LLC I Nov-30-2018
28 GE Medical Systems, LLC II Jan-21-2016
29 Getinge Group Logistics America, LLC II Oct-09-2020
30 Getinge Usa Sales Inc II Aug-24-2022
31 Getinge Usa Sales Inc I Aug-22-2022
32 Hamilton Medical AG I Jun-18-2024
33 Hamilton Medical AG II Apr-25-2023
34 Hamilton Medical AG II Nov-18-2022
35 Hamilton Medical AG I Aug-19-2022
36 Hamilton Medical AG I Jul-11-2019
37 Hamilton Medical AG II Aug-14-2018
38 Hamilton Medical AG II Apr-12-2018
39 Hamilton Medical, Inc. I Sep-20-2023
40 Hamilton Medical, Inc. I Jul-21-2023
41 Hamilton Medical, Inc. II Nov-28-2016
42 Hamilton Medical, Inc. II May-09-2016
43 Hill-Rom Manufacturing, Inc. II Nov-24-2020
44 Medtronic formerly Covidien I Apr-25-2022
45 NIHON KOHDEN ORANGEMED, INC II Sep-08-2021
46 Newport Medical Instruments Inc I Apr-10-2017
47 Percussionaire Corporation I Jan-17-2024
48 Percussionaire Corporation I Jan-17-2024
49 Percussionaire Corporation II Nov-07-2023
50 Philips Respironics II Mar-07-2016
51 Philips Respironics, Inc. I Sep-05-2024
52 Philips Respironics, Inc. I Apr-17-2024
53 Philips Respironics, Inc. II Jan-04-2024
54 Philips Respironics, Inc. II Jul-07-2023
55 Philips Respironics, Inc. I Jun-02-2023
56 Philips Respironics, Inc. I Apr-03-2023
57 Philips Respironics, Inc. I Jan-06-2023
58 Philips Respironics, Inc. I Mar-18-2022
59 Philips Respironics, Inc. I Jan-22-2022
60 Philips Respironics, Inc. II Aug-13-2021
61 Philips Respironics, Inc. I Jul-15-2021
62 Philips Respironics, Inc. I Feb-15-2020
63 ResMed Ltd. I Oct-23-2023
64 Resmed Corporation II Feb-03-2016
65 Spacelabs Healthcare, Ltd. I Aug-10-2018
66 Ventec Life Systems, Inc. I Feb-23-2024
67 Ventec Life Systems, Inc. II Jun-21-2021
68 Vyaire Medical II Jun-15-2023
69 Vyaire Medical I Feb-16-2022
70 Vyaire Medical II Mar-04-2020
71 ZOLL Medical Corporation I Jun-20-2024
72 ZOLL Medical Corporation II Mar-01-2018
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