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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

MDR Year MDR Reports MDR Events
2019 37 37
2020 67 67
2021 248 248
2022 335 335
2023 1257 1257
2024 335 335

Device Problems MDRs with this Device Problem Events in those MDRs
Protective Measures Problem 1128 1128
Battery Problem 450 450
Inadequate User Interface 172 172
Electrical /Electronic Property Problem 162 162
Failure of Device to Self-Test 123 123
Device Displays Incorrect Message 120 120
Failure to Calibrate 112 112
Failure to Charge 108 108
Power Problem 93 93
Failure to Power Up 74 74
Inappropriate Tactile Prompt/Feedback 73 73
Unexpected Shutdown 59 59
Complete Loss of Power 47 47
Charging Problem 35 35
Degraded 24 24
Premature Discharge of Battery 24 24
Therapeutic or Diagnostic Output Failure 24 24
Unexpected Therapeutic Results 23 23
Device Alarm System 20 20
Display or Visual Feedback Problem 17 17
Adverse Event Without Identified Device or Use Problem 16 16
Output Problem 13 13
Key or Button Unresponsive/not Working 12 12
Inappropriate or Unexpected Reset 11 11
Pressure Problem 10 10
No Tactile Prompts/Feedback 9 9
Circuit Failure 9 9
No Audible Alarm 9 9
Capacitative Coupling 9 9
Operating System Becomes Nonfunctional 8 8
Insufficient Information 8 8
Accessory Incompatible 7 7
Mechanical Problem 6 6
Material Split, Cut or Torn 6 6
Intermittent Loss of Power 5 5
Nonstandard Device 5 5
No Display/Image 5 5
Contamination 4 4
False Alarm 4 4
Moisture Damage 4 4
Failure to Run on Battery 4 4
Defective Component 4 4
Application Program Freezes, Becomes Nonfunctional 4 4
Temperature Problem 3 3
Appropriate Term/Code Not Available 3 3
Use of Device Problem 3 3
Human-Device Interface Problem 3 3
Overheating of Device 3 3
Particulates 3 3
Break 3 3
Defective Alarm 2 2
Alarm Not Visible 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
Noise, Audible 2 2
Moisture or Humidity Problem 2 2
Problem with Software Installation 1 1
No Visual Prompts/Feedback 1 1
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
Improper or Incorrect Procedure or Method 1 1
Tidal Volume Fluctuations 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
Use of Incorrect Control/Treatment Settings 1 1
Disconnection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1950 1950
No Consequences Or Impact To Patient 181 181
Insufficient Information 75 75
Low Oxygen Saturation 28 28
No Patient Involvement 16 16
Death 7 7
Cardiac Arrest 6 6
Respiratory Arrest 6 6
Aspiration/Inhalation 4 4
Dyspnea 4 4
Loss of consciousness 3 3
Diaphoresis 3 3
Pneumonia 3 3
Respiratory Insufficiency 3 3
Swelling/ Edema 3 3
No Known Impact Or Consequence To Patient 3 3
Respiratory Failure 3 3
Dizziness 2 2
Unspecified Infection 2 2
Discomfort 2 2
Pain 1 1
Tachycardia 1 1
Eye Injury 1 1
Hypersensitivity/Allergic reaction 1 1
Hypoxia 1 1
Abnormal Blood Gases 1 1
Cardiopulmonary Arrest 1 1
Blister 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Confusion/ Disorientation 1 1
Abdominal Distention 1 1
No Information 1 1
Cancer 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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