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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 7

Device Problems
Noise, Audible 69
Device displays error message 68
Device operates differently than expected 41
Battery issue 32
Power source issue 25
Charging issue 11
Connection issue 11
Break 7
Filling problem 7
Loose or intermittent connection 7
Mechanical issue 7
Device alarm system issue 6
False alarm 5
Failure to charge 5
Incorrect display 4
No display or display failure 3
Device inoperable 3
Computer operating system issue 3
Pressure issue 3
Improper device output 3
Low battery 3
Failure to disconnect 2
Failure to power-up 2
Difficult to insert 2
Slippage of device or device component 2
No code available 2
No Known Device Problem 2
Nonstandard device or device component 2
Material rigid or stiff 2
Material rupture 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
Application interface becomes non-functional or program exits abnormally 1
Electrical issue 1
Fracture 1
Grounding malfunction 1
Failure to sense 1
Material separation 1
Short fill 1
Unintended collision 1
Loss of power 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
Output issue 1
Device handling issue 1
Temperature issue 1
Difficult to remove 1
Ambient noise issue 1
Improper flow or infusion 1
Inappropriate or unexpected reset 1
Item contaminated during manufacturing or shipping 1
Mechanical jam 1
Mushroomed 1
Electrical power problem 1
Failure of device to self-test 1
Human-Device Interface Issue 1
Total Device Problems 386

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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