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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device ventilator, continuous, minimal ventilatory support, facility use
Regulation Description Continuous ventilator.
Product CodeMNT
Regulation Number 868.5895
Device Class 2

Device Problems
Device Displays Incorrect Message 185
Device Operates Differently Than Expected 155
Device Inoperable 90
Failure to Power Up 48
Alarm, Audible 43
Loss of Power 34
Device Alarm System 29
Data Acquisition Unit 26
Battery Problem 24
No Display / Image 23
Pressure Sensor 20
Pressure Problem 17
Sensor 17
Adverse Event Without Identified Device or Use Problem 16
Battery 15
Failure to Charge 13
Leak / Splash 12
Power Problem 12
No Flow 10
Failure to Sense 10
Device Operational Issue 10
Temperature Problem 10
Failure of Device to Self-Test 9
Screen 8
Device Issue 8
Unexpected Shutdown 6
Display 6
No Audible Alarm 5
Electrical /Electronic Property Problem 5
Device Emits Odor 5
Failure To Run On AC/DC 5
Mechanical Problem 5
Break 5
Data Problem 5
Device Handling Problem 4
Device Sensing Problem 4
Device Stops Intermittently 4
Overheating of Device 4
Infusion or Flow Problem 3
Calibration Problem 3
Charging Problem 3
Material Discolored 3
Unit 3
Human-Device Interface Problem 3
Occlusion Within Device 3
Blower 3
Calibration Error 3
Use of Incorrect Control Settings 3
PC (Printed Circuit) Board 3
Gas output problem 2
Volume Accuracy Problem 2
Smoking 2
Premature Discharge of Battery 2
Physical Property Issue 2
Detachment of Device or device Component 2
Output Problem 2
No Apparent Adverse Event 2
Delivery System Failure 2
Protective Measures Problem 2
Application Interface Becomes Non-Functional Or Program Exits Abnormally 2
Increase in Pressure 2
Circuit Failure 2
Fire 2
Appropriate Term/Code Not Available 2
Ventilation Problem in Device Environment 1
Component Missing 1
Medical Gas Supply Problem 1
Insufficient Cooling 1
Air Leak 1
Alarm Not Visible 1
Tidal Volume Fluctuations 1
False Negative Result 1
Improper or Incorrect Procedure or Method 1
Sparking 1
Device Difficult to Setup or Prepare 1
Decrease in Pressure 1
Connection Problem 1
Mechanics Altered 1
Alarm 1
Display or Visual Feedback Problem 1
Alarm, Oxygen Pressure 1
Cable 1
Gauges/Meters 1
Device Subassembly 1
Battery Charger 1
Misassembly by Users 1
Noise, Audible 1
Unintended Collision 1
No Device Output 1
Poor Quality Image 1
Disconnection 1
Discrete Component/Device (Resistor, Capacitor, Diode) 1
Naturally Worn 1
Reset Problem 1
No Pressure 1
Excess Flow or Over-Infusion 1
Failure to Pump 1
Inadequacy of Device Shape and/or Size 1
Under-Sensing 1
Out-Of-Box Failure 1
Total Device Problems 1006

Recalls
Manufacturer Recall Class Date Posted
1 Respironics California Inc I May-18-2017
2 Respironics California Inc II Mar-27-2017

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