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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 8

Device Problems
Noise, Audible 72
Device displays error message 71
Device operates differently than expected 61
Battery issue 34
Power source issue 25
Mechanical issue 17
Charging issue 15
Connection issue 11
Break 8
Device alarm system issue 7
Filling problem 7
Loose or intermittent connection 7
No display or display failure 5
Incorrect display 5
False alarm 5
Failure to charge 5
Pressure issue 4
No code available 3
Computer operating system issue 3
Low battery 3
Improper device output 3
Device inoperable 3
Nonstandard device or device component 2
Material rigid or stiff 2
Material rupture 2
Failure to sense 2
Component falling 2
Computer software issue 2
Premature discharge of battery 2
Disconnection 2
Erratic display 2
Air leak 2
Difficult to insert 2
Failure to disconnect 2
Slippage of device or device component 2
Failure to power-up 2
No Known Device Problem 2
Output issue 1
Device handling issue 1
Temperature issue 1
Failure to pump 1
Difficult to remove 1
Ambient noise issue 1
Improper flow or infusion 1
Inappropriate or unexpected reset 1
Item contaminated during manufacturing or shipping 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
Electrical issue 1
Bent 1
Defective Alarm 1
Use of Incorrect Control Settings 1
Crack 1
Application interface becomes non-functional or program exits abnormally 1
Material separation 1
Short fill 1
Unintended collision 1
Loss of power 1
Unstable 1
Use of Device Issue 1
Vibration 1
Volume accuracy issue 1
Fitting problem 1
Component missing 1
Overfill 1
Low readings 1
Total Device Problems 439

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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