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, minimal ventilatory support, facility use
Product CodeMNT
Regulation Number 868.5895
Device Class 2


Premarket Reviews
ManufacturerDecision
FISHER & PAYKEL HEALTHCARE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
NIHON KOHDEN ORANGEMED, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 2202 2202
2019 9350 9350
2020 4170 4170
2021 3791 3791
2022 3277 3277
2023 644 644

Device Problems MDRs with this Device Problem Events in those MDRs
Inadequate User Interface 2318 2318
Defective Component 1915 1915
Therapeutic or Diagnostic Output Failure 1446 1446
Incorrect, Inadequate or Imprecise Result or Readings 1440 1440
Defective Device 1259 1259
Battery Problem 1208 1208
Device Alarm System 1133 1133
Device Displays Incorrect Message 993 993
Failure to Power Up 814 814
Output Problem 791 791
Device Sensing Problem 756 756
Power Problem 621 621
No Display/Image 598 598
Display or Visual Feedback Problem 495 495
Defective Alarm 458 458
Unexpected Shutdown 443 443
Break 344 344
Noise, Audible 328 328
Failure to Calibrate 315 315
Excessive Heating 300 300
Gas/Air Leak 293 293
Pressure Problem 279 279
Mechanical Problem 271 271
Loss of Power 247 247
Failure to Read Input Signal 246 246
Protective Measures Problem 245 245
Calibration Problem 207 207
Self-Activation or Keying 202 202
Temperature Problem 201 201
Appropriate Term/Code Not Available 197 197
Failure to Charge 191 191
Failure to Shut Off 189 189
Computer Operating System Problem 173 173
Electrical /Electronic Property Problem 154 154
No Flow 148 148
Infusion or Flow Problem 128 128
Failure of Device to Self-Test 127 127
Tidal Volume Fluctuations 127 127
Device Operates Differently Than Expected 122 122
Poor Quality Image 116 116
Operating System Becomes Nonfunctional 98 98
Leak/Splash 96 96
Insufficient Flow or Under Infusion 96 96
Improper Flow or Infusion 95 95
Unintended Power Up 92 92
Crack 88 88
Display Difficult to Read 88 88
Failure to Deliver 82 82
Insufficient Information 81 81
Increase in Pressure 80 80
Application Program Freezes, Becomes Nonfunctional 78 78
Volume Accuracy Problem 77 77
Device Inoperable 77 77
Image Display Error/Artifact 76 76
Key or Button Unresponsive/not Working 75 75
Failure to Sense 70 70
Energy Output Problem 70 70
Inaccurate Flow Rate 69 69
Overheating of Device 68 68
Obstruction of Flow 68 68
Gas Output Problem 66 66
Charging Problem 65 65
Adverse Event Without Identified Device or Use Problem 65 65
Intermittent Loss of Power 60 60
Disconnection 56 56
No Audible Alarm 55 55
Failure to Run on Battery 55 55
Degraded 54 54
Circuit Failure 54 54
Failure to Align 52 52
Vibration 51 51
Component Missing 48 48
No Device Output 45 45
Use of Device Problem 43 43
Material Integrity Problem 43 43
Audible Prompt/Feedback Problem 43 43
Computer Software Problem 42 42
Failure to Zero 41 41
Decrease in Pressure 41 41
Mechanical Jam 41 41
Detachment of Device or Device Component 41 41
Loose or Intermittent Connection 40 40
Device Emits Odor 38 38
No Audible Prompt/Feedback 35 35
Erratic or Intermittent Display 34 34
Connection Problem 32 32
Application Program Problem 31 31
Inaccurate Delivery 30 30
Communication or Transmission Problem 29 29
Complete Loss of Power 29 29
Intermittent Energy Output 29 29
Use of Incorrect Control/Treatment Settings 27 27
Unable to Obtain Readings 24 24
No Pressure 24 24
Human-Device Interface Problem 24 24
Inappropriate or Unexpected Reset 23 23
Blocked Connection 23 23
Excess Flow or Over-Infusion 23 23
Nonstandard Device 23 23
Physical Resistance/Sticking 22 22

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 8646 8646
No Patient Involvement 8521 8521
No Known Impact Or Consequence To Patient 4122 4122
No Consequences Or Impact To Patient 1427 1427
Insufficient Information 526 526
Low Oxygen Saturation 91 91
Hypoxia 82 82
Death 75 75
Dyspnea 20 20
Cardiac Arrest 11 11
No Information 11 11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Unspecified Respiratory Problem 8 8
No Code Available 7 7
Respiratory Distress 7 7
Cardiopulmonary Arrest 6 6
Bradycardia 6 6
Respiratory Arrest 6 6
Respiratory Failure 6 6
Injury 6 6
Pressure Sores 4 4
Pain 4 4
Fall 3 3
Pneumonia 3 3
Bacterial Infection 3 3
Loss of consciousness 3 3
Aspiration Pneumonitis 3 3
Discomfort 3 3
Lethargy 2 2
Asystole 2 2
Patient Problem/Medical Problem 2 2
Increased Respiratory Rate 2 2
Apnea 2 2
Chest Pain 2 2
Cyanosis 2 2
Fainting 2 2
Pulmonary Emphysema 2 2
Tachycardia 2 2
Tissue Damage 2 2
Urinary Retention 1 1
Vomiting 1 1
Pneumothorax 1 1
Renal Failure 1 1
Septic Shock 1 1
Asphyxia 1 1
Hematoma 1 1
High Blood Pressure/ Hypertension 1 1
Low Blood Pressure/ Hypotension 1 1
Pleural Effusion 1 1
Infiltration into Tissue 1 1
Inflammation 1 1
Encephalopathy 1 1
Bruise/Contusion 1 1
Congenital Defect/Deformity 1 1
Abnormal Blood Gases 1 1
Adult Respiratory Distress Syndrome 1 1
Cognitive Changes 1 1
Respiratory Acidosis 1 1
Fungal Infection 1 1
Respiratory Tract Infection 1 1
Sweating 1 1
Distress 1 1
Ventilator Dependent 1 1
Hypoxia in Utero 1 1
Chronic Obstructive Pulmonary Disease (COPD) 1 1
Therapeutic Response, Decreased 1 1
Respiratory Insufficiency 1 1
Wheezing 1 1
Cardiovascular Insufficiency 1 1
Heart Failure/Congestive Heart Failure 1 1
Foreign Body In Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Philips Respironics, Inc. II May-21-2021
2 ResMed Ltd. I Feb-07-2020
3 Respironics California, LLC I Apr-18-2022
4 Respironics California, LLC I Feb-25-2022
5 Respironics California, LLC I Jul-22-2021
6 Respironics California, LLC II Feb-19-2021
7 Respironics California, LLC II Jan-22-2021
8 Respironics California, LLC II Jan-22-2021
9 Respironics California, LLC II Mar-31-2020
10 Respironics California, LLC II Mar-02-2020
-
-