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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 3

Device Problems
Device displays error message 91
Noise, Audible 75
Device operates differently than expected 73
Battery issue 51
Power source issue 33
Mechanical issue 27
Charging issue 26
Connection issue 13
Failure to charge 11
Electrical issue 10
Break 9
No display or display failure 9
Loose or intermittent connection 8
Filling problem 7
Device alarm system issue 7
Incorrect display 6
False alarm 5
Material rupture 5
No code available 5
Computer operating system issue 5
Use of Device Issue 4
Pressure issue 4
Improper device output 3
Device inoperable 3
Low battery 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 sense 2
Difficult to insert 2
Failure to power-up 2
Nonstandard device or device component 2
Failure to disconnect 2
Device Issue 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
Failure to pump 1
Difficult to remove 1
Material separation 1
Short fill 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 563

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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