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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 5

Device Problems
No Known Device Problem 5603
Other (for use when an appropriate device code cannot be identified) 4637
Battery issue 2212
Connection issue 1409
Device stops intermittently 1369
Loose or intermittent connection 1004
Power source issue 960
Infusion or flow issue 851
Pumping issue 757
High Readings 677
Break 620
Device operates differently than expected 475
Decreased pump speed 450
Pumping stopped 313
Obstruction within device 309
Foreign material present in device 300
Electrical shorting 267
Device alarm system issue 234
No Information 207
Not audible alarm 190
Use of Device Issue 153
Disconnection 135
Device displays error message 132
Contamination during use 127
Loss of power 119
Malposition of device 117
No display or display failure 96
Overheating of device or device component 94
Blockage within device or device component 86
Communication or transmission issue 85
Occlusion within device 78
Electrical issue 75
Image display error 69
Maintenance does not comply to manufacturers recommendations 65
Output issue 58
Increased pump speed 58
Bent 54
Kinked 52
Malfunction 52
Torn material 50
Cut in material 48
Device Issue 47
Low audible alarm 47
Protective measure issue 46
Material deformation 45
Premature discharge of battery 41
Detachment of device component 38
Migration of device or device component 37
Noise, Audible 35
Improper flow or infusion 33
Circuit Failure 33
Failure to power-up 33
Data Issue 32
Material integrity issue 28
Leak 28
Restricted flowrate 28
Device inoperable 26
Vibration 25
Air leak 22
Naturally worn 20
Alarm not visible 19
Poor quality image 18
Failure to pump 18
Low readings 18
Fracture 17
Hole in material 16
Low battery 15
No code available 14
Temperature issue 13
Dislodged or dislocated 13
Device or device component damaged by another device 13
Incorrect display 12
Mechanical issue 10
Improper or incorrect procedure or method 10
Insufficient flow or underinfusion 9
Human-Device Interface Issue 9
Material twisted 9
Difficult to open or close 9
Detachment of device or device component 8
Issue with displayed error message 8
No flow 8
Material separation 8
Patient-device incompatibility 8
Failure to charge 8
Crack 8
Particulates 7
Electro-static discharge 7
Improper alarm 7
Device handling issue 6
Fitting problem 6
Increase in suction 6
Power Conditioning Issue 6
Charging issue 6
Moisture damage 6
False alarm 5
Problem with software installation 5
Positioning Issue 4
Decoupling 4
Degraded 4
Smoking 4
Total Device Problems 25672

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 3 0 0 1 0 1 0 2 5 3 3
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 I Apr-27-2017
20 Heartware I Apr-25-2017
21 Heartware Inc II May-14-2013
22 Thoratec Corp II Nov-24-2009
23 Thoratec Corp II Dec-22-2008
24 Thoratec Corp I Nov-21-2007
25 Thoratec Corp I Jul-27-2007
26 Thoratec Corp I Jul-27-2007
27 Thoratec Corp II Feb-10-2007
28 Thoratec Corp II Oct-13-2010
29 Thoratec Corporation I May-24-2017
30 Thoratec Corporation I Mar-21-2014
31 Thoratec Corporation I Mar-23-2012

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