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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


Premarket Reviews
ManufacturerDecision
FISHER & PAYKEL HEALTHCARE LIMITED
  SUBSTANTIALLY EQUIVALENT 1

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
Adverse Event Without Identified Device or Use Problem 17
Sensor 17
Failure to Charge 15
Battery 15
Power Problem 12
Leak/Splash 12
Device Operational Issue 10
Temperature Problem 10
No Flow 10
Failure to Sense 10
Break 9
Insufficient Information 9
Failure of Device to Self-Test 9
Screen 8
Unexpected Shutdown 8
Device Issue 8
No Audible Alarm 6
Display 6
Electrical /Electronic Property Problem 5
Device Emits Odor 5
Data Problem 5
Failure To Run On AC/DC 5
Mechanical Problem 5
Device Stops Intermittently 4
Device Handling Problem 4
Device Sensing Problem 4
Complete Loss of Power 4
Protective Measures Problem 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
PC (Printed Circuit) Board 3
Occlusion Within Device 3
Blower 3
Calibration Error 3
Use of Incorrect Control Settings 3
Smoking 2
Premature Discharge of Battery 2
Physical Property Issue 2
Low Audible Alarm 2
Gas Output Problem 2
Volume Accuracy Problem 2
Detachment of Device or Device Component 2
Output Problem 2
No Apparent Adverse Event 2
Delivery System Failure 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, Electrical 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 Electrical Component 1
Naturally Worn 1
Intermittent Loss of Power 1
Failure to Calibrate 1
Communication or Transmission Problem 1
Manifold 1
Total Device Problems 1030

Recalls
Manufacturer Recall Class Date Posted
1 ResMed Ltd. I Feb-07-2020
2 Respironics California Inc I May-18-2017
3 Respironics California Inc II Mar-27-2017
4 Respironics California, LLC II Mar-31-2020
5 Respironics California, LLC II Mar-02-2020

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