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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 2017
1 1 1 2 2 5 3 7 7 10 0

Device Problems
Device displays error message 86
Noise, Audible 74
Device operates differently than expected 72
Battery issue 48
Power source issue 32
Mechanical issue 27
Charging issue 25
Connection issue 11
Break 9
Failure to charge 9
Electrical issue 9
Filling problem 7
Device alarm system issue 7
Loose or intermittent connection 7
No display or display failure 6
Incorrect display 6
False alarm 5
Computer operating system issue 5
Use of Device Issue 4
Pressure issue 4
No code available 4
Material rupture 4
Erratic display 3
Air leak 3
Low battery 3
Improper device output 3
Device inoperable 3
Slippage of device or device component 2
Failure to disconnect 2
No Known Device Problem 2
Device handling issue 2
Disconnection 2
Crack 2
Premature discharge of battery 2
Component falling 2
Computer software issue 2
Difficult to insert 2
Nonstandard device or device component 2
Failure to sense 2
Material rigid or stiff 2
Failure to power-up 2
Failure to pump 1
Difficult to remove 1
Material separation 1
Short fill 1
Unintended collision 1
Loss of power 1
Use of Incorrect Control Settings 1
Bent 1
Defective Alarm 1
Application interface becomes non-functional or program exits abnormally 1
Fracture 1
Grounding malfunction 1
Temperature issue 1
Output issue 1
Improper flow or infusion 1
Inappropriate or unexpected reset 1
Item contaminated during manufacturing or shipping 1
Material integrity issue 1
Mechanical jam 1
Mushroomed 1
Device sensing issue 1
Electrical power problem 1
Failure of device to self-test 1
Human-Device Interface Issue 1
Unstable 1
Ambient noise issue 1
Vibration 1
Volume accuracy issue 1
Improper or incorrect procedure or method 1
Fitting problem 1
Component missing 1
Device Issue 1
Overfill 1
Low readings 1
Total Device Problems 538

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 1 1 0
Class II 0 1 0 0 0 0 0 0 0 0 0
Class III 0 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 Dec-08-2016
3 SynCardia Systems Inc. I Sep-17-2015

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