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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
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
GENERAL ELECTRIC CO.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Failure to Calibrate 973
Device Displays Incorrect Message 813
Power Problem 208
Battery Problem 203
Inappropriate or Unexpected Reset 129
No Display / Image 103
Device Inoperable 102
Charging Problem 90
Device Stops Intermittently 80
Pressure Problem 28
Failure to Charge 26
Device Alarm System 25
Failure to Power Up 25
Device Sensing Problem 17
Protective Measures Problem 17
Adverse Event Without Identified Device or Use Problem 11
Device Operational Issue 10
Appropriate Term/Code Not Available 8
Failure To Run On AC/DC 8
Device Operates Differently Than Expected 8
Low Battery 6
Communication or Transmission Problem 6
Battery 5
Calibration Problem 5
No Audible Alarm 5
Temperature Problem 4
Insufficient Heating 4
Loss of Power 4
No Flow 4
Blower 3
Failure to Shut Off 3
Switch, Push Button 3
Material Frayed 2
Fracture 2
Alarm Not Visible 2
Circuit Failure 2
Insufficient Cooling 2
Failure to Cycle 2
Keyboard 2
Decrease in Pressure 2
Increase in Pressure 2
Detachment Of Device Component 2
Unexpected Shutdown 2
Premature Discharge of Battery 2
Failure to Deliver 2
Volume Accuracy Problem 2
Complete Loss of power 2
Improper Alarm 2
Failure to Discharge 2
Data Problem 1
Incorrect Measurement 1
Lithium Iodide Battery 1
Power Module 1
Delayed Alarm 1
Device Issue 1
Failure to Run on Battery 1
Material Integrity Problem 1
Insufficient Information 1
Melted 1
Crack 1
Fail-Safe Design Failure 1
Calibration Error 1
No Pressure 1
Display or Visual Feedback Problem 1
Inadequate User Interface 1
Infusion or Flow Problem 1
Leak / Splash 1
Keypad 1
Device Difficult to Program or Calibrate 1
Pumping Stopped 1
Defective Component 1
Output Problem 1
Battery Charger 1
Cooling Module 1
Noise, Audible 1
Display 1
Total Device Problems 2997

Recalls
Manufacturer Recall Class Date Posted
1 Breas Medical AB II Jul-16-2015
2 Breas Medical, Inc. II Feb-24-2020
3 Human Design Medical Llc III Jul-23-2018

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