• 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 continuous, ventilator, home use
Regulation Description Continuous ventilator.
Definition This product code was needed for the home use indication. CBK is not a tracked device and NOU is a tracked device.
Product CodeNOU
Regulation Number 868.5895
Device Class 2


Premarket Reviews
ManufacturerDecision
BREAS MEDICAL AB
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2020 67 67
2021 248 248
2022 336 336
2023 1259 1259
2024 815 815
2025 62 62

Device Problems MDRs with this Device Problem Events in those MDRs
Protective Measures Problem 1483 1483
Battery Problem 489 489
Inadequate User Interface 224 224
Electrical /Electronic Property Problem 166 166
Failure of Device to Self-Test 123 123
Device Displays Incorrect Message 119 119
Power Problem 118 118
Failure to Charge 116 116
Failure to Power Up 99 99
Failure to Calibrate 97 97
Inappropriate Tactile Prompt/Feedback 77 77
Complete Loss of Power 65 65
Unexpected Shutdown 62 62
Charging Problem 53 53
Therapeutic or Diagnostic Output Failure 32 32
Adverse Event Without Identified Device or Use Problem 29 29
Unexpected Therapeutic Results 27 27
Degraded 24 24
Device Alarm System 24 24
Premature Discharge of Battery 23 23
Display or Visual Feedback Problem 19 19
No Audible Alarm 14 14
Output Problem 13 13
Key or Button Unresponsive/not Working 12 12
Insufficient Information 11 11
Inappropriate or Unexpected Reset 11 11
Material Split, Cut or Torn 10 10
Accessory Incompatible 9 9
Circuit Failure 9 9
Capacitative Coupling 9 9
No Tactile Prompts/Feedback 9 9
Pressure Problem 9 9
Operating System Becomes Nonfunctional 8 8
Appropriate Term/Code Not Available 7 7
Mechanical Problem 6 6
Intermittent Loss of Power 5 5
No Display/Image 5 5
Nonstandard Device 5 5
Alarm Not Visible 4 4
Failure to Run on Battery 4 4
Contamination 4 4
Application Program Freezes, Becomes Nonfunctional 4 4
Defective Component 4 4
Moisture Damage 4 4
False Alarm 4 4
Overheating of Device 3 3
Human-Device Interface Problem 3 3
Defective Alarm 3 3
Break 3 3
Use of Device Problem 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2461 2461
No Consequences Or Impact To Patient 150 150
Insufficient Information 89 89
Low Oxygen Saturation 39 39
No Patient Involvement 16 16
Loss of consciousness 9 9
Cardiac Arrest 6 6
Respiratory Arrest 6 6
Death 5 5
Aspiration/Inhalation 4 4
Respiratory Insufficiency 4 4
Respiratory Failure 4 4
Dyspnea 4 4
Pneumonia 3 3
Swelling/ Edema 3 3
Diaphoresis 3 3
Discomfort 2 2
Confusion/ Disorientation 2 2
Dizziness 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Unspecified Infection 2 2
Syncope/Fainting 1 1
Lethargy 1 1
Cyanosis 1 1
Blister 1 1
Hypoxia 1 1
Unspecified Respiratory Problem 1 1
Hypersensitivity/Allergic reaction 1 1
Pain 1 1
Abnormal Blood Gases 1 1
Cardiopulmonary Arrest 1 1
Eye Injury 1 1
Cancer 1 1
Pneumothorax 1 1
Abdominal Distention 1 1
Tachycardia 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Breas Medical, Inc. I Sep-03-2024
2 Breas Medical, Inc. II Nov-27-2023
3 Breas Medical, Inc. II Jul-13-2022
4 Breas Medical, Inc. II Feb-24-2020
5 Philips Respironics, Inc. I Sep-05-2024
6 Philips Respironics, Inc. II Aug-13-2021
-
-