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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 43
Product Quality Problem 19
Output Problem 16
Break 14
Failure to Deliver 14
Electrical /Electronic Property Problem 13
No Pressure 12
Device Operates Differently Than Expected 11
Decrease in Pressure 9
Device Stops Intermittently 6
Device Displays Incorrect Message 5
Peeled / Delaminated 5
Pressure Problem 5
Noise, Audible 4
Degraded 4
No Device Output 3
Device Alarm System 3
Loss of Power 3
Unexpected Shutdown 2
Detachment Of Device Component 2
Moisture or Humidity Problem 2
Fire 2
Radiation overexposure 1
Implant Mobility NOS (Not otherwise specified) 1
Infusion or Flow Problem 1
Electronic Property Issue 1
Valve 1
Smoking 1
No Flow 1
No Apparent Adverse Event 1
Appropriate Term/Code Not Available 1
Contamination / decontamination Problem 1
Adverse Event Without Identified Device or Use Problem 1
Nebulizer (Only Use When Part Of Another Device) 1
Circuit Failure 1
Thermal Decomposition of Device 1
Overheating of Device 1
Inaccurate Delivery 1
Delivery System Failure 1
Mechanical Problem 1
Failure To Run On AC/DC 1
Arcing 1
Compressor (Air Pump) 1
Device Handling Problem 1
Intermittent loss of power 1
Total Device Problems 320

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

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