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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device ventricular (assisst) bypass
Definition Approved pma: P870072
Product CodeDSQ
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
7 5 9 12 4 20 36 30 24 37 2

Device Problems
No Known Device Problem 5199
Other (for use when an appropriate device code cannot be identified) 4637
Battery issue 2134
Connection issue 1344
Device stops intermittently 1284
Power source issue 900
Loose or intermittent connection 825
Infusion or flow issue 749
Pumping issue 696
High Readings 619
Break 534
Device operates differently than expected 474
Decreased pump speed 435
Pumping stopped 300
Foreign material present in device 300
Obstruction within device 261
Electrical shorting 247
Device alarm system issue 230
No Information 195
Not audible alarm 186
Use of Device Issue 149
Disconnection 127
Contamination during use 126
Device displays error message 125
Loss of power 119
Malposition of device 110
Overheating of device or device component 93
No display or display failure 89
Communication or transmission issue 85
Occlusion within device 77
Electrical issue 72
Blockage within device or device component 69
Image display error 67
Maintenance does not comply to manufacturers recommendations 62
Increased pump speed 58
Output issue 57
Bent 54
Malfunction 52
Torn material 50
Kinked 49
Device Issue 47
Cut in material 46
Low audible alarm 46
Premature discharge of battery 41
Detachment of device component 38
Material deformation 38
Noise, Audible 35
Migration of device or device component 35
Circuit Failure 33
Improper flow or infusion 32
Failure to power-up 31
Protective measure issue 30
Data Issue 28
Leak 27
Vibration 25
Device inoperable 22
Air leak 22
Naturally worn 20
Alarm not visible 19
Low readings 18
Failure to pump 17
Poor quality image 17
Fracture 17
Hole in material 16
Low battery 15
No code available 14
Temperature issue 13
Device or device component damaged by another device 13
Dislodged or dislocated 13
Improper or incorrect procedure or method 10
Mechanical issue 10
Incorrect display 10
Human-Device Interface Issue 9
Material twisted 9
Difficult to open or close 9
Issue with displayed error message 8
Material integrity issue 8
Detachment of device or device component 8
Failure to charge 8
Patient-device incompatibility 8
Insufficient flow or underinfusion 7
Electro-static discharge 7
Material separation 7
Restricted flowrate 7
Particulates 7
No flow 7
Device handling issue 6
Improper alarm 6
Power Conditioning Issue 6
Moisture damage 6
Crack 6
Increase in suction 6
Fitting problem 5
Charging issue 5
Positioning Issue 4
Problem with software installation 4
Smoking 4
Decoupling 4
Degraded 4
Erratic display 3
Total Device Problems 24215

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 3 0 0 1 0 1 0 2 5 3 0
Class II 2 1 3 1 0 0 3 1 2 0 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Abiomed, Inc. I Mar-04-2010
2 Abiomed, Inc. II Sep-16-2009
3 Abiomed, Inc. II Sep-01-2009
4 Abiomed, Inc. II Mar-07-2007
5 Carestream Health Inc. II Nov-13-2013
6 HeartWare Inc I Oct-17-2016
7 HeartWare Inc I Jul-08-2016
8 HeartWare Inc II Jun-26-2015
9 HeartWare Inc I Jun-13-2015
10 HeartWare Inc I Jun-11-2015
11 HeartWare Inc II Jun-10-2015
12 HeartWare Inc I Jun-08-2015
13 HeartWare Inc I May-14-2015
14 HeartWare Inc I Feb-25-2015
15 HeartWare Inc II May-14-2014
16 HeartWare Inc I Apr-23-2014
17 HeartWare Inc II Jul-29-2013
18 HeartWare, Inc I Oct-13-2016
19 Heartware Inc II May-14-2013
20 Thoratec Corp II Nov-24-2009
21 Thoratec Corp II Dec-22-2008
22 Thoratec Corp I Nov-21-2007
23 Thoratec Corp I Jul-27-2007
24 Thoratec Corp I Jul-27-2007
25 Thoratec Corp II Feb-10-2007
26 Thoratec Corp II Oct-13-2010
27 Thoratec Corporation I Mar-21-2014
28 Thoratec Corporation I Mar-23-2012

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