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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 10

Device Problems
Device displays error message 81
Noise, Audible 72
Device operates differently than expected 67
Battery issue 48
Power source issue 27
Mechanical issue 26
Charging issue 25
Connection issue 11
Break 8
Device alarm system issue 7
Electrical issue 7
Filling problem 7
Loose or intermittent connection 7
No display or display failure 6
Incorrect display 6
Failure to charge 6
False alarm 5
Computer operating system issue 4
Pressure issue 4
No code available 4
Improper device output 3
Low battery 3
Use of Device Issue 3
Device inoperable 3
Erratic display 3
Difficult to insert 2
Failure to power-up 2
Nonstandard device or device component 2
Slippage of device or device component 2
Material rigid or stiff 2
Material rupture 2
Failure to sense 2
Premature discharge of battery 2
Component falling 2
Computer software issue 2
Air leak 2
Disconnection 2
Failure to disconnect 2
No Known Device Problem 2
Output issue 1
Device handling issue 1
Temperature issue 1
Ambient noise issue 1
Vibration 1
Volume accuracy issue 1
Fitting problem 1
Component missing 1
Overfill 1
Low readings 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
Fracture 1
Grounding malfunction 1
Use of Incorrect Control Settings 1
Crack 1
Application interface becomes non-functional or program exits abnormally 1
Bent 1
Defective Alarm 1
Material separation 1
Short fill 1
Unstable 1
Unintended collision 1
Loss of power 1
Failure to pump 1
Difficult to remove 1
Total Device Problems 505

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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