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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


Premarket Reviews
ManufacturerDecision
BEAR MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIRD PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
EMG
  SUBSTANTIALLY EQUIVALENT 1
ERIE MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
EVENT MEDICAL LTD
  SUBSTANTIALLY EQUIVALENT 1
HAMILTON
  SUBSTANTIALLY EQUIVALENT 1
IMPACT INSTRUMENTATION, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL INDUSTRIES AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 4
MEDLINE
  SUBSTANTIALLY EQUIVALENT 1
NEWPORT
  SUBSTANTIALLY EQUIVALENT 1
OHMEDA MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
PRECISION MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
SIEMENS
  SUBSTANTIALLY EQUIVALENT 2
THE JOHN BUNN CO.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Device inoperable 62
Failure to power-up 57
Improper flow or infusion 49
Product quality issue 20
Failure to deliver 19
No Pressure 16
Break 15
Device operates differently than expected 14
No Information 10
Electrical issue 9
Decrease in pressure 8
Malfunction 8
Device stops intermittently 7
Defective item 6
Device displays error message 6
Overheating of device or device component 6
Peeled 5
Failure to run on AC/DC 5
Pressure issue 5
Fire 4
Loss of power 4
Device alarm system issue 3
No device output 3
Fuse, blown 3
Spark 3
Smoking 3
Noise, Audible 3
No code available 2
Moisture or humidity problem 2
No flow 2
Detachment of device component 2
Air leak 2
Burn of device or device component 1
Circuit Failure 1
Leak 1
Mechanical issue 1
Melted 1
Device emits odor 1
Failure to cycle 1
Inappropriate shock 1
Suction issue 1
Out-of-box failure 1
Radiation overexposure 1
Implant Mobility NOS (Not otherwise specified) 1
Delivery system failure 1
Arcing 1
Inaccurate delivery 1
No Known Device Problem 1
Not Applicable 1
Electronic property issue 1
Device handling issue 1
Total Device Problems 382

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 1 0 0 0 0 0 0 1 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Draeger Medical, Inc. II Apr-05-2007
2 Maquet Cardiovascular Us Sales, Llc II Jan-28-2014

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