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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 7

Device Problems
Device displays error message 109
Device operates differently than expected 78
Noise, Audible 75
Battery issue 56
Power source issue 40
Mechanical issue 32
Charging issue 31
Connection issue 19
Failure to charge 11
No display or display failure 11
Incorrect display 10
Electrical issue 10
Break 10
Loose or intermittent connection 8
Filling problem 7
Device alarm system issue 7
No code available 7
Material rupture 6
False alarm 5
Computer operating system issue 5
Use of Device Issue 5
Device Issue 5
Low readings 4
Difficult to insert 4
Pressure issue 4
Device handling issue 3
Erratic display 3
Difficult to remove 3
Incorrect or inadequate result 3
Air leak 3
Crack 3
Device inoperable 3
Low battery 3
Improper device output 3
No Known Device Problem 2
Failure to disconnect 2
Slippage of device or device component 2
High Readings 2
Premature discharge of battery 2
Component falling 2
Computer software issue 2
Material rigid or stiff 2
Failure to power-up 2
Failure to sense 2
Disconnection 2
Nonstandard device or device component 2
Unintended collision 1
Overheating of device or device component 1
Loss of power 1
Material separation 1
Short fill 1
Failure to pump 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
Ambient noise issue 1
Unstable 1
Overfill 1
Vibration 1
Volume accuracy issue 1
Improper or incorrect procedure or method 1
Fitting problem 1
Component missing 1
Output issue 1
Positioning Issue 1
Device sensing issue 1
Electrical power problem 1
Failure of device to self-test 1
Human-Device Interface Issue 1
Improper flow or infusion 1
Inappropriate or unexpected reset 1
Item contaminated during manufacturing or shipping 1
Manufacturing or shipping issue associated with device 1
Material integrity issue 1
Mechanical jam 1
Mushroomed 1
Temperature issue 1
Total Device Problems 644

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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