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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
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 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 24955 24955
2024 6744 6744

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 11829 11829
Output Problem 9211 9211
Circuit Failure 6503 6503
Failure to Recalibrate 4337 4337
Failure to Run on Battery 3906 3906
Defective Component 3710 3710
Battery Problem 3670 3704
No Display/Image 3578 3578
Electrical /Electronic Property Problem 2964 2964
Display or Visual Feedback Problem 2206 2206
Gas/Air Leak 1978 1978
Failure to Charge 1857 1873
Failure to Power Up 1845 1845
Protective Measures Problem 1837 1876
Failure of Device to Self-Test 1816 1816
Failure to Calibrate 1691 1957
Improper Flow or Infusion 1651 1651
Degraded 1552 1552
Contamination 1282 1282
Insufficient Information 1241 1241
Unexpected Shutdown 1226 1226
Infusion or Flow Problem 1178 1178
No Flow 1075 1075
Leak/Splash 1036 1036
Failure to Deliver 1034 1034
Power Problem 1000 1042
Decrease in Pressure 970 970
Device Displays Incorrect Message 938 938
Pressure Problem 788 788
Insufficient Flow or Under Infusion 772 772
Gas Output Problem 766 766
Calibration Problem 692 692
Therapeutic or Diagnostic Output Failure 658 658
Application Program Problem 543 543
Complete Loss of Power 513 513
Adverse Event Without Identified Device or Use Problem 498 498
Incorrect, Inadequate or Imprecise Result or Readings 473 473
Computer Software Problem 465 465
Inadequate User Interface 441 445
Communication or Transmission Problem 383 383
Device Alarm System 381 381
Use of Device Problem 356 356
Connection Problem 346 346
Tidal Volume Fluctuations 285 285
Increase in Pressure 252 252
Excess Flow or Over-Infusion 212 212
Peeled/Delaminated 211 211
Contamination /Decontamination Problem 211 211
Loose or Intermittent Connection 209 209
Defective Device 208 208
Reset Problem 200 200
Premature Discharge of Battery 199 199
Break 199 199
False Positive Result 193 193
Appropriate Term/Code Not Available 188 188
Noise, Audible 186 186
Inaccurate Delivery 181 181
Obstruction of Flow 180 180
Medical Gas Supply Problem 177 177
Alarm Not Visible 177 177
Smoking 174 174
Temperature Problem 167 167
Charging Problem 163 163
Defective Alarm 160 160
Fracture 160 160
Failure to Conduct 159 159
Device Sensing Problem 154 154
Detachment of Device or Device Component 147 147
Erratic or Intermittent Display 146 146
Disconnection 135 135
Low Readings 134 134
Key or Button Unresponsive/not Working 134 134
No Pressure 125 125
No Audible Alarm 117 117
No Visual Prompts/Feedback 115 115
Unexpected Therapeutic Results 113 113
Inappropriate or Unexpected Reset 113 114
Incomplete or Inadequate Connection 108 108
Mechanical Jam 105 105
Inaccurate Flow Rate 102 102
Loss of Power 100 100
Volume Accuracy Problem 99 99
Electrical Shorting 96 96
No Apparent Adverse Event 92 92
Decreased Pump Speed 90 90
Intermittent Continuity 90 90
Device Handling Problem 87 87
Intermittent Communication Failure 87 87
Failure to Cycle 86 86
Failure to Read Input Signal 86 86
Failure to Sense 83 83
Activation Failure 83 83
Accessory Incompatible 82 82
Suction Problem 79 79
Unintended Collision 78 78
Application Program Freezes, Becomes Nonfunctional 74 74
Overheating of Device 70 70
Computer Operating System Problem 70 70
Free or Unrestricted Flow 70 70
No Tactile Prompts/Feedback 69 69

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 58705 58705
No Patient Involvement 8546 8546
No Consequences Or Impact To Patient 8083 8484
Insufficient Information 1633 1633
No Known Impact Or Consequence To Patient 1036 1037
Low Oxygen Saturation 876 876
No Information 865 865
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 255 255
Unspecified Respiratory Problem 229 229
Dyspnea 220 220
Death 184 184
Headache 168 168
Respiratory Failure 148 148
Cardiac Arrest 125 125
Respiratory Insufficiency 121 121
Respiratory Tract Infection 86 86
Cough 83 83
Ventilator Dependent 78 78
Sore Throat 76 76
Dizziness 72 72
No Code Available 66 66
Hypoxia 64 64
Bradycardia 62 62
Pneumothorax 50 50
Nausea 47 47
Respiratory Arrest 40 40
Cyanosis 37 37
Cancer 34 34
Pneumonia 29 29
Hypoventilation 29 29
Unspecified Kidney or Urinary Problem 27 27
Skin Inflammation/ Irritation 26 26
Asthma 25 25
Low Blood Pressure/ Hypotension 24 24
Discomfort 24 24
Loss of consciousness 23 23
Vomiting 23 23
Increased Respiratory Rate 23 23
Respiratory Distress 20 20
Hypersensitivity/Allergic reaction 19 19
Chronic Obstructive Pulmonary Disease (COPD) 19 19
Tachycardia 19 19
Chest Pain 18 18
Patient Problem/Medical Problem 18 18
Apnea 17 17
Cardiopulmonary Arrest 16 16
Unspecified Infection 16 16
Inflammation 16 16
Respiratory Acidosis 15 15
Unspecified Eye / Vision Problem 15 15
Unspecified Heart Problem 15 15
Heart Failure/Congestive Heart Failure 12 12
Injury 12 12
Abnormal Blood Gases 11 11
Epistaxis 11 11
Unspecified Hepatic or Biliary Problem 11 11
Nodule 10 10
Anxiety 9 9
Stroke/CVA 8 8
Dry Eye(s) 8 8
Fatigue 8 8
Hyperventilation 8 8
Renal Failure 8 8
Swelling/ Edema 8 8
Rash 7 7
High Blood Pressure/ Hypertension 7 7
Liver Damage/Dysfunction 6 6
Pain 6 6
Burn(s) 6 6
Urinary Retention 6 6
Bowel Perforation 6 6
Convulsion/Seizure 6 6
Thrombosis/Thrombus 5 5
Sleep Dysfunction 5 5
Coma 5 5
Sinus Perforation 5 5
Fever 5 5
Adult Respiratory Distress Syndrome 5 5
Airway Obstruction 5 5
Necrosis 5 5
Perforation 4 4
Hemoptysis 4 4
Hemorrhage/Bleeding 4 4
Fall 4 4
Aspiration/Inhalation 4 4
Pulmonary Emphysema 4 4
Encephalopathy 4 4
Overinflation of Lung 4 4
Brain Injury 4 4
Burning Sensation 4 4
Partial thickness (Second Degree) Burn 4 4
Confusion/ Disorientation 4 4
Electric Shock 4 4
Asystole 4 4
Cardiovascular Insufficiency 4 4
Speech Disorder 4 4
Wheezing 4 4
Dry Mouth 4 4
Unspecified Gastrointestinal Problem 3 3
Eye Infections 3 3

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 II Nov-06-2020
4 Covidien, LP I Dec-09-2021
5 Draeger Medical, Inc. I Aug-18-2023
6 Draeger Medical, Inc. I Jul-08-2023
7 Draeger Medical, Inc. I Feb-24-2023
8 Draeger Medical, Inc. II Apr-04-2022
9 Draeger Medical, Inc. II Oct-14-2021
10 Draeger Medical, Inc. II May-28-2021
11 GE Healthcare, LLC I Jun-06-2022
12 GE Healthcare, LLC II Aug-24-2020
13 GE Healthcare, LLC II Dec-17-2019
14 Getinge Group Logistics America, LLC II Oct-09-2020
15 Getinge Usa Sales Inc II Aug-24-2022
16 Getinge Usa Sales Inc I Aug-22-2022
17 Hamilton Medical AG II Apr-25-2023
18 Hamilton Medical AG II Nov-18-2022
19 Hamilton Medical AG I Aug-19-2022
20 Hamilton Medical AG I Jul-11-2019
21 Hamilton Medical, Inc. I Sep-20-2023
22 Hamilton Medical, Inc. I Jul-21-2023
23 Hill-Rom Manufacturing, Inc. II Nov-24-2020
24 Medtronic formerly Covidien I Apr-25-2022
25 NIHON KOHDEN ORANGEMED, INC II Sep-08-2021
26 Percussionaire Corporation I Jan-17-2024
27 Percussionaire Corporation I Jan-17-2024
28 Percussionaire Corporation II Nov-07-2023
29 Philips Respironics, Inc. II Jan-04-2024
30 Philips Respironics, Inc. II Jul-07-2023
31 Philips Respironics, Inc. I Jun-02-2023
32 Philips Respironics, Inc. I Apr-03-2023
33 Philips Respironics, Inc. I Jan-06-2023
34 Philips Respironics, Inc. I Mar-18-2022
35 Philips Respironics, Inc. I Jan-22-2022
36 Philips Respironics, Inc. II Aug-13-2021
37 Philips Respironics, Inc. I Jul-15-2021
38 Philips Respironics, Inc. I Feb-15-2020
39 ResMed Ltd. I Oct-23-2023
40 Ventec Life Systems, Inc. I Feb-23-2024
41 Ventec Life Systems, Inc. II Jun-21-2021
42 Vyaire Medical II Jun-15-2023
43 Vyaire Medical I Feb-16-2022
44 Vyaire Medical II Mar-04-2020
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