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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
COVIDIEN, LLC
  SUBSTANTIALLY EQUIVALENT 1
  1.  K193056  Puritan Bennett 980 Series Ventilator System
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
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 2
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

MDR Year MDR Reports MDR Events
2019 9100 9502
2020 11096 11096
2021 13322 13322
2022 15976 15976
2023 24956 24956
2024 15439 15439

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 12233 12233
Output Problem 10379 10379
Circuit Failure 6853 6853
Failure to Recalibrate 4681 4681
Battery Problem 4219 4253
Failure to Run on Battery 4138 4138
No Display/Image 4024 4024
Defective Component 3845 3845
Electrical /Electronic Property Problem 3650 3650
Gas/Air Leak 2358 2358
Display or Visual Feedback Problem 2338 2338
Degraded 2224 2224
Failure to Power Up 2221 2221
Failure to Calibrate 2051 2317
Failure to Charge 1975 1991
Failure of Device to Self-Test 1919 1919
Protective Measures Problem 1839 1878
Improper Flow or Infusion 1829 1829
Unexpected Shutdown 1441 1441
Insufficient Information 1426 1426
Contamination 1389 1389
Insufficient Flow or Under Infusion 1315 1315
Infusion or Flow Problem 1280 1280
No Flow 1196 1196
Power Problem 1178 1220
Failure to Deliver 1165 1165
Leak/Splash 1053 1053
Decrease in Pressure 1052 1052
Device Displays Incorrect Message 939 939
Gas Output Problem 919 919
Pressure Problem 838 838
Therapeutic or Diagnostic Output Failure 727 727
Calibration Problem 711 711
Complete Loss of Power 624 624
Application Program Problem 557 557
Adverse Event Without Identified Device or Use Problem 541 541
Computer Software Problem 483 483
Incorrect, Inadequate or Imprecise Result or Readings 479 479
Inadequate User Interface 448 452
Device Alarm System 410 410
Communication or Transmission Problem 404 404
Connection Problem 394 394
Use of Device Problem 371 371
Increase in Pressure 302 302
Tidal Volume Fluctuations 299 299
Loose or Intermittent Connection 240 240
False Positive Result 228 228
Contamination /Decontamination Problem 223 223
Excess Flow or Over-Infusion 217 217
Peeled/Delaminated 214 214

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 66675 66675
No Patient Involvement 8546 8546
No Consequences Or Impact To Patient 8083 8484
Insufficient Information 1771 1771
No Known Impact Or Consequence To Patient 1036 1037
Low Oxygen Saturation 976 976
No Information 865 865
Unspecified Respiratory Problem 515 515
Headache 344 344
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 276 276
Dizziness 247 247
Dyspnea 241 241
Death 184 184
Respiratory Failure 165 165
Asthma 161 161
Cancer 154 154
Cardiac Arrest 135 135
Unspecified Kidney or Urinary Problem 129 129
Respiratory Tract Infection 128 128
Respiratory Insufficiency 126 126
Nausea 111 111
Skin Inflammation/ Irritation 96 96
Vomiting 90 90
Cough 86 86
Ventilator Dependent 81 81
Inflammation 80 80
Sore Throat 76 76
Hypoxia 74 74
Hypersensitivity/Allergic reaction 71 71
Bradycardia 70 70
No Code Available 66 66
Unspecified Heart Problem 59 59
Pneumothorax 52 52
Respiratory Arrest 50 50
Pneumonia 50 50
Chronic Obstructive Pulmonary Disease (COPD) 44 44
Cyanosis 41 41
Unspecified Hepatic or Biliary Problem 34 34
Hypoventilation 31 31
Discomfort 26 26
Low Blood Pressure/ Hypotension 26 26
Increased Respiratory Rate 25 25
Heart Failure/Congestive Heart Failure 24 24
Loss of consciousness 23 23
Chest Pain 21 21
Tachycardia 21 21
Respiratory Distress 20 20
Apnea 19 19
Patient Problem/Medical Problem 18 18
Pulmonary Dysfunction 17 17

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 I Aug-02-2024
5 Covidien Llc I Dec-09-2021
6 Covidien Llc II Nov-06-2020
7 Draeger Medical, Inc. I Aug-18-2023
8 Draeger Medical, Inc. I Jul-08-2023
9 Draeger Medical, Inc. I Feb-24-2023
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 GE Healthcare, LLC I Jun-06-2022
14 GE Healthcare, LLC II Aug-24-2020
15 GE Healthcare, LLC II Dec-17-2019
16 Getinge Group Logistics America, LLC II Oct-09-2020
17 Getinge Usa Sales Inc II Aug-24-2022
18 Getinge Usa Sales Inc I Aug-22-2022
19 Hamilton Medical AG I Jun-18-2024
20 Hamilton Medical AG II Apr-25-2023
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, Inc. I Sep-20-2023
25 Hamilton Medical, Inc. I Jul-21-2023
26 Hill-Rom Manufacturing, Inc. II Nov-24-2020
27 Medtronic formerly Covidien I Apr-25-2022
28 NIHON KOHDEN ORANGEMED, INC II Sep-08-2021
29 Percussionaire Corporation I Jan-17-2024
30 Percussionaire Corporation I Jan-17-2024
31 Percussionaire Corporation II Nov-07-2023
32 Philips Respironics, Inc. I Sep-05-2024
33 Philips Respironics, Inc. I Apr-17-2024
34 Philips Respironics, Inc. II Jan-04-2024
35 Philips Respironics, Inc. II Jul-07-2023
36 Philips Respironics, Inc. I Jun-02-2023
37 Philips Respironics, Inc. I Apr-03-2023
38 Philips Respironics, Inc. I Jan-06-2023
39 Philips Respironics, Inc. I Mar-18-2022
40 Philips Respironics, Inc. I Jan-22-2022
41 Philips Respironics, Inc. II Aug-13-2021
42 Philips Respironics, Inc. I Jul-15-2021
43 Philips Respironics, Inc. I Feb-15-2020
44 ResMed Ltd. I Oct-23-2023
45 Ventec Life Systems, Inc. I Feb-23-2024
46 Ventec Life Systems, Inc. II Jun-21-2021
47 Vyaire Medical II Jun-15-2023
48 Vyaire Medical I Feb-16-2022
49 Vyaire Medical II Mar-04-2020
50 ZOLL Medical Corporation I Jun-20-2024
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