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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device compressor, air, portable
Regulation Description Portable air compressor.
Product CodeBTI
Regulation Number 868.6250
Device Class 2

Device Problems
Device Inoperable 55
Improper Flow or Infusion 45
Failure to Power Up 34
Product Quality Problem 19
Break 14
Failure to Deliver 12
No Pressure 12
Device Operates Differently Than Expected 11
Device Stops Intermittently 6
Decrease in Pressure 6
Electrical /Electronic Property Problem 6
Peeled / Delaminated 5
Device Displays Incorrect Message 5
Pressure Problem 5
Degraded 4
Loss of Power 3
No Device Output 3
Device Alarm System 3
Noise, Audible 3
Detachment Of Device Component 2
Fire 2
Moisture or Humidity Problem 2
No Flow 1
Adverse Event Without Identified Device or Use Problem 1
Implant Mobility NOS (Not otherwise specified) 1
Delivery System Failure 1
Electronic Property Issue 1
Smoking 1
Inaccurate Delivery 1
Arcing 1
Radiation overexposure 1
Mechanical Problem 1
Overheating of Device 1
Thermal Decomposition of Device 1
Circuit Failure 1
Valve 1
Compressor (Air Pump) 1
Nebulizer (Only Use When Part Of Another Device) 1
Failure To Run On AC/DC 1
Output Problem 1
No Apparent Adverse Event 1
Appropriate Term/Code Not Available 1
Device Handling Problem 1
Total Device Problems 278

Recalls
Manufacturer Recall Class Date Posted
1 Maquet Cardiovascular Us Sales, Llc II Jan-28-2014

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