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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device artificial heart
Definition P030011
Product CodeLOZ
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
1 1 1 2 2 5 3 7 7 8

Device Problems
Device displays error message 69
Noise, Audible 69
Device operates differently than expected 51
Battery issue 32
Power source issue 25
Mechanical issue 12
Charging issue 11
Connection issue 11
Loose or intermittent connection 7
Break 7
Filling problem 7
Device alarm system issue 6
False alarm 5
Failure to charge 5
Incorrect display 5
No display or display failure 4
Device inoperable 3
Low battery 3
Computer operating system issue 3
Pressure issue 3
Improper device output 3
No code available 3
No Known Device Problem 2
Slippage of device or device component 2
Failure to disconnect 2
Material rigid or stiff 2
Material rupture 2
Difficult to insert 2
Failure to power-up 2
Nonstandard device or device component 2
Air leak 2
Disconnection 2
Erratic display 2
Component falling 2
Computer software issue 2
Premature discharge of battery 2
Bent 1
Defective Alarm 1
Use of Incorrect Control Settings 1
Crack 1
Application interface becomes non-functional or program exits abnormally 1
Electrical issue 1
Fracture 1
Grounding malfunction 1
Unintended collision 1
Loss of power 1
Difficult to remove 1
Unstable 1
Use of Device Issue 1
Vibration 1
Volume accuracy issue 1
Fitting problem 1
Component missing 1
Overfill 1
Low readings 1
Failure to sense 1
Material separation 1
Short fill 1
Ambient noise issue 1
Electrical power problem 1
Failure of device to self-test 1
Human-Device Interface Issue 1
Output issue 1
Temperature issue 1
Improper flow or infusion 1
Inappropriate or unexpected reset 1
Item contaminated during manufacturing or shipping 1
Mechanical jam 1
Mushroomed 1
Device handling issue 1
Total Device Problems 406

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

Recalls
Manufacturer Recall Class Date Posted
1 Abiomed, Inc. II Sep-20-2008
2 SynCardia Systems Inc. I Sep-17-2015

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