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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 6

Device Problems
Device displays error message 98
Noise, Audible 75
Device operates differently than expected 74
Battery issue 51
Power source issue 34
Charging issue 29
Mechanical issue 27
Connection issue 13
Failure to charge 11
No display or display failure 10
Electrical issue 10
Break 9
Loose or intermittent connection 8
Filling problem 7
Incorrect display 7
Device alarm system issue 7
No code available 7
Computer operating system issue 5
False alarm 5
Material rupture 5
Use of Device Issue 4
Pressure issue 4
Improper device output 3
Device inoperable 3
Device Issue 3
Low battery 3
Difficult to insert 3
Erratic display 3
Air leak 3
Crack 3
Disconnection 2
Premature discharge of battery 2
Component falling 2
Computer software issue 2
Failure to power-up 2
Failure to sense 2
Nonstandard device or device component 2
Failure to disconnect 2
Material rigid or stiff 2
Slippage of device or device component 2
No Known Device Problem 2
Device handling issue 2
Output issue 1
Temperature 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
Vibration 1
Volume accuracy issue 1
Improper or incorrect procedure or method 1
Fitting problem 1
Component missing 1
Overfill 1
Low readings 1
Ambient noise issue 1
Unintended collision 1
Loss of power 1
Fracture 1
Grounding malfunction 1
Material separation 1
Short fill 1
Failure to pump 1
Difficult to remove 1
Use of Incorrect Control Settings 1
Bent 1
Defective Alarm 1
Application interface becomes non-functional or program exits abnormally 1
Total Device Problems 581

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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