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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device continuous, ventilator, home use
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 1
  1.  K193586  Vivo 45 LS

MDR Year MDR Reports MDR Events
2019 37 37
2020 67 67
2021 248 248
2022 335 335
2023 1236 1236
2024 194 194

Device Problems MDRs with this Device Problem Events in those MDRs
Protective Measures Problem 1026 1026
Battery Problem 438 438
Electrical /Electronic Property Problem 162 162
Inadequate User Interface 148 148
Failure of Device to Self-Test 123 123
Device Displays Incorrect Message 120 120
Failure to Calibrate 112 112
Failure to Charge 104 104
Power Problem 83 83
Failure to Power Up 74 74
Inappropriate Tactile Prompt/Feedback 71 71
Unexpected Shutdown 59 59
Complete Loss of Power 45 45
Charging Problem 35 35
Degraded 24 24
Therapeutic or Diagnostic Output Failure 24 24
Premature Discharge of Battery 20 20
Device Alarm System 18 18
Unexpected Therapeutic Results 17 17
Display or Visual Feedback Problem 15 15
Adverse Event Without Identified Device or Use Problem 13 13
Output Problem 13 13
Key or Button Unresponsive/not Working 12 12
Pressure Problem 10 10
No Tactile Prompts/Feedback 9 9
Inappropriate or Unexpected Reset 9 9
Circuit Failure 9 9
Capacitative Coupling 9 9
Operating System Becomes Nonfunctional 8 8
Insufficient Information 8 8
No Audible Alarm 7 7
Mechanical Problem 6 6
Nonstandard Device 5 5
No Display/Image 5 5
Intermittent Loss of Power 5 5
Application Program Freezes, Becomes Nonfunctional 4 4
Contamination 4 4
Moisture Damage 4 4
Failure to Run on Battery 4 4
Defective Component 4 4
Human-Device Interface Problem 3 3
Overheating of Device 3 3
Particulates 3 3
Break 3 3
Temperature Problem 3 3
Noise, Audible 2 2
Moisture or Humidity Problem 2 2
Alarm Not Visible 2 2
False Alarm 2 2
Defective Alarm 2 2
Device Emits Odor 2 2
Image Display Error/Artifact 2 2
Leak/Splash 2 2
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Device Sensing Problem 2 2
Difficult to Open or Close 2 2
Detachment of Device or Device Component 2 2
Insufficient Flow or Under Infusion 2 2
Contamination /Decontamination Problem 2 2
Patient-Device Incompatibility 2 2
Ambient Temperature Problem 1 1
Defective Device 1 1
Communication or Transmission Problem 1 1
Connection Problem 1 1
No Audible Prompt/Feedback 1 1
Inaccurate Delivery 1 1
Tidal Volume Fluctuations 1 1
Use of Device Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Device Markings/Labelling Problem 1 1
Calibration Problem 1 1
Electrical Power Problem 1 1
Failure to Shut Off 1 1
Gas/Air Leak 1 1
Improper Flow or Infusion 1 1
Battery Problem: Low Impedance 1 1
Material Integrity Problem 1 1
Material Twisted/Bent 1 1
Mechanics Altered 1 1
Self-Activation or Keying 1 1
Failure to Read Input Signal 1 1
Smoking 1 1
Loss of Power 1 1
Unable to Obtain Readings 1 1
Energy Output Problem 1 1
Accessory Incompatible 1 1
Use of Incorrect Control/Treatment Settings 1 1
Disconnection 1 1
Problem with Software Installation 1 1
No Visual Prompts/Feedback 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1809 1809
No Consequences Or Impact To Patient 181 181
Insufficient Information 74 74
No Patient Involvement 16 16
Low Oxygen Saturation 11 11
Death 7 7
Cardiac Arrest 6 6
Respiratory Arrest 6 6
Aspiration/Inhalation 4 4
Pneumonia 3 3
Respiratory Failure 3 3
Loss of consciousness 3 3
Diaphoresis 3 3
Dyspnea 3 3
Respiratory Insufficiency 3 3
No Known Impact Or Consequence To Patient 3 3
Swelling/ Edema 2 2
Unspecified Infection 2 2
Discomfort 2 2
Abdominal Distention 1 1
Pain 1 1
Cardiopulmonary Arrest 1 1
Eye Injury 1 1
Hypersensitivity/Allergic reaction 1 1
Hypoxia 1 1
No Information 1 1
Cancer 1 1
Blister 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

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