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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device automated external defibrillators (non-wearable)
Regulation Description Automated external defibrillator system.
Definition This device is a non-wearable prescription use only aed. These are devices that include automated external defibrillation. Automated external defibrillators use external pad-type electrodes to sense, detect, classify and treat (with an electrical shock) ventricular fibrillation. These devices are intended to be used on suspected victims of sudden cardiac arrest. A person in cardiac arrest is unresponsive and is not breathing normally. The device can be sold with prescription only.
Product CodeMKJ
Regulation Number 870.5310
Device Class 3


Premarket Reviews
ManufacturerDecision
ACCESS CARDIOSYSTEMS, INC.
  1
AGILENT TECHNIOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 4
AMBU INTERNATIONAL A/S
  SUBSTANTIALLY EQUIVALENT 1
AMCO INTERNATIONAL MANUFACTURING & DESIGN, INC.
  SUBSTANTIALLY EQUIVALENT 3
BIO-DETEK, INC.
  SUBSTANTIALLY EQUIVALENT 10
CARDIAC SCIENCE CORPORATION
  2
  SUBSTANTIALLY EQUIVALENT 15
COLORADO MEDTECH
  SUBSTANTIALLY EQUIVALENT 1
CONCORD
  SUBSTANTIALLY EQUIVALENT 1
CU MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
DEFIBTECH, LLC
  1
  SUBSTANTIALLY EQUIVALENT 6
HEARTSINE TECHNOLOGIES, LTD.
  SUBSTANTIALLY EQUIVALENT 6
HEWLETT-PACKARD CO.
  1
  SUBSTANTIALLY EQUIVALENT 5
KATECHO, INC.
  SUBSTANTIALLY EQUIVALENT 7
LAERDAL MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 2
LEONHARD LANG GMBH
  SUBSTANTIALLY EQUIVALENT 5
MARQUETTE
  SUBSTANTIALLY EQUIVALENT 4
MEDICAL RESEARCH LAB., INC.
  3
  SUBSTANTIALLY EQUIVALENT 4
MEDICOTEST A/S
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  2
  SUBSTANTIALLY EQUIVALENT 10
PHILIPS MEDICAL SYSTEMS
  2
  SUBSTANTIALLY EQUIVALENT 15
PHYSIO-CONTROL, INC.
  2
  SUBSTANTIALLY EQUIVALENT 16
SURVIVALINK CORP.
  1
  SUBSTANTIALLY EQUIVALENT 5
WELCH ALLYN, INC.
  SUBSTANTIALLY EQUIVALENT 2
ZOLL MEDICAL CORPORATION
  5
  SUBSTANTIALLY EQUIVALENT 47

Device Problems
Device operates differently than expected 3714
Device displays error message 2061
Failure to power-up 1631
Device inoperable 1139
Self-activation or keying 948
Failure to run on AC/DC 844
Failure to deliver energy 676
Loss of power 493
Failure of device to self-test 473
No Known Device Problem 445
Failure to charge 410
Use of Incorrect Control Settings 250
No voice prompts 235
No display or display failure 210
Power source issue 175
Connection issue 149
Failure to shock or properly shock 142
Failure to sense 131
Device sensing issue 110
Failure to analyze rhythm 108
Failure to discharge 104
Battery issue 95
Premature discharge of battery 84
Break 76
Computer operating system issue 66
Device Issue 66
Inappropriate shock 57
Noise, Audible 55
Device damaged prior to use 54
Low battery 51
Output energy incorrect 48
Charging issue 46
Device stops intermittently 42
Failure to pace or properly pace 27
Intermittent continuity 25
EKG/ECG analysis, failure to perform 24
Inappropriate prompts 24
Defective component 22
Loose or intermittent connection 22
Component(s), broken 22
Communication or transmission issue 22
No Information 21
Out-of-box failure 21
Inaudible voice prompts 19
Output issue 19
Defective item 18
Incorrect interpretation of rhythm 18
Burn of device or device component 18
Device alarm system issue 17
Aborted charge 17
Failure to read input signal 17
Failure to Adhere or Bond 16
Difficult or delayed activation 16
Device emits odor 15
Unable to obtain readings 14
Delayed charge time 14
Failure to deliver 13
Component missing 13
Artifact 13
Blank screen 13
Application interface becomes non-functional or program exits abnormally 12
Detachment of device component 12
Failure to calibrate 12
Material Distortion 12
Improper device output 12
Reset issue 11
Battery failure 11
Not audible alarm 11
Image display error 11
Use of Device Issue 11
Poor quality image 11
Improper or incorrect procedure or method 10
Smoking 10
Material fragmentation 9
Fire 8
Component falling 8
Inaccurate synchronization 8
Fitting problem 8
No device output 8
Arcing at electrodes 7
Connection error 7
Bent 7
Incorrect display 7
Inappropriate or unexpected reset 7
Spark 7
Calibration issue 6
Failure to shut off 6
Naturally worn 6
Failure to deliver countershock 6
Intermittent shock 6
Volume accuracy issue 6
Mechanical issue 6
Device remains activated 6
Alarm system, failure of message-leads off 5
Inaccurate delivery 5
Erratic display 5
Electrical issue 5
Leak 5
Mechanical jam 5
Failure to fire 5
Total Device Problems 16008

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 3 0 5 5 1 2 0 4 0 1
Class II 6 12 11 17 7 5 10 19 8 5
Class III 0 1 0 1 1 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 BatteryZone, Inc. II Dec-22-2007
2 Bio-Detek, Inc. II Oct-09-2014
3 Bio-Detek, Inc. II Sep-17-2014
4 Bio-Detek, Inc. II Sep-02-2014
5 Cardiac Science Corporation II Mar-09-2016
6 Cardiac Science Corporation I Feb-27-2012
7 Cardiac Science Corporation II Sep-19-2011
8 Cardiac Science Corporation II Aug-03-2011
9 Cardiac Science Corporation II Dec-10-2010
10 Cardiac Science Corporation II Jun-21-2010
11 Cardiac Science Corporation II May-26-2010
12 Cardiac Science Corporation I Apr-27-2010
13 Cardiac Science Corporation II Apr-06-2010
14 Cardiac Science Corporation I Mar-04-2010
15 Cardiac Science Corporation II Feb-25-2009
16 Cardiac Science Corporation II Sep-17-2008
17 Cardiac Science Corporation III May-21-2008
18 ConMed Corporation I Dec-04-2014
19 ConMed Corporation II May-13-2013
20 Covidien LLC II Sep-02-2015
21 Covidien LLC I Oct-15-2014
22 Defibtech LLC I Jun-10-2010
23 Defibtech, LLC I May-16-2011
24 Defibtech, LLC II Oct-18-2010
25 Defibtech, LLC I Mar-08-2007
26 Exocomm Tech Grp II Jan-26-2008
27 Heart Sync, Inc. I Dec-24-2014
28 Heartsine Technologies, Limited II Jul-24-2014
29 Heartsine Technologies, Limited I Oct-27-2012
30 Leonhard Lang Gmbh I Dec-19-2014
31 Leonhard Lang Gmbh II Sep-24-2009
32 Leonhard Lang Medizintechnik GmbH I Oct-14-2016
33 Medtronic Emergency Response Systems, Inc. II Jun-21-2007
34 Medtronic Emergency Response Systems, Inc. II Mar-29-2007
35 Philips Electronics North America Corporation II Sep-19-2016
36 Philips Electronics North America Corporation II Jun-02-2016
37 Philips Electronics North America Corporation II Nov-20-2015
38 Philips Electronics North America Corporation II Nov-13-2015
39 Philips Electronics North America Corporation II Aug-04-2015
40 Philips Healthcare Inc. II Jul-24-2013
41 Philips Healthcare Inc. II Apr-29-2013
42 Philips Healthcare Inc. II Feb-21-2013
43 Philips Healthcare Inc. II Oct-04-2012
44 Philips Healthcare Inc. II Sep-10-2012
45 Philips Healthcare Inc. II Jul-11-2012
46 Philips Healthcare Inc. II Jun-27-2012
47 Philips Healthcare Inc. II Mar-08-2011
48 Philips Healthcare Inc. II Nov-08-2010
49 Philips Healthcare Inc. II Aug-27-2010
50 Philips Healthcare Inc. II May-24-2010
51 Philips Healthcare Inc. II Apr-09-2010
52 Philips Healthcare Inc. II Apr-08-2010
53 Philips Healthcare Inc. II Mar-15-2010
54 Philips Healthcare Inc. II Dec-23-2009
55 Philips Healthcare Inc. II Nov-09-2009
56 Philips Healthcare Inc. II Jul-24-2009
57 Philips Healthcare Inc. II Jun-02-2009
58 Philips Healthcare Inc. II May-19-2009
59 Philips Medical Systems II Nov-29-2010
60 Philips Medical Systems II Nov-26-2010
61 Philips Medical Systems III Nov-22-2010
62 Philips Medical Systems II Jun-28-2010
63 Philips Medical Systems II Mar-23-2010
64 Philips Medical Systems II Dec-08-2009
65 Philips Medical Systems II Sep-25-2008
66 Philips Medical Systems II Jul-09-2008
67 Philips Medical Systems II Oct-25-2007
68 Philips Medical Systems II Aug-07-2007
69 Philips Medical Systems II Mar-22-2007
70 Philips Medical Systems North America Co. Phillips II Jan-04-2013
71 Philips Medical Systems North America Inc. II Mar-19-2014
72 Philips Medical Systems North America Inc. II Mar-19-2014
73 Philips Medical Systems, Inc. II Nov-10-2015
74 Philips Medical Systems, Inc. II Nov-05-2015
75 Philips Medical Systems, Inc. II Nov-03-2015
76 Philips Medical Systems, Inc. II Jan-13-2015
77 Philips Medical Systems, Inc. II Apr-09-2014
78 Philips Medical Systems, Inc. II Apr-09-2014
79 Philips Medical Systems, Inc. II Mar-12-2014
80 Philips Medical Systems, Inc. II Mar-07-2014
81 Philips Medical Systems, Inc. II Feb-26-2014
82 Philips Medical Systems, Inc. II Feb-26-2014
83 Philips Medical Systems, Inc. II Feb-26-2014
84 Philips Medical Systems, Inc. II Feb-26-2014
85 Philips Medical Systems, Inc. II Feb-26-2014
86 Philips Medical Systems, Inc. II Feb-26-2014
87 Philips Medical Systems, Inc. II Feb-25-2014
88 Philips Medical Systems, Inc. II Dec-31-2013
89 Philips Medical Systems, Inc. II Dec-27-2013
90 Philips Medical Systems, Inc. II Dec-24-2013
91 Physio Control, Inc. II Jul-19-2013
92 Physio Control, Inc. II Apr-10-2013
93 Physio Control, Inc. II Jul-26-2011
94 Physio Control, Inc. III Jun-22-2011
95 Physio Control, Inc. II Mar-18-2011
96 Physio Control, Inc. II Mar-04-2011
97 Physio Control, Inc. I Jul-01-2010
98 Physio Control, Inc. I Apr-21-2010
99 Physio Control, Inc. II Feb-22-2010
100 Physio Control, Inc. I Sep-14-2009
101 Physio Control, Inc. II Oct-30-2008
102 Physio Control, Inc. II Sep-21-2008
103 Physio Control, Inc. II Sep-16-2008
104 Physio Control, Inc. II Sep-11-2008
105 Physio Control, Inc. II Aug-24-2008
106 Physio Control, Inc. II Mar-29-2008
107 Physio-Control, Inc. II Jun-29-2016
108 Physio-Control, Inc. II Jun-15-2016
109 Physio-Control, Inc. II May-23-2014
110 Siemens Medical Solutions USA, Inc. II Feb-15-2008
111 Welch Allyn Protocol, Inc II Jul-06-2009
112 Welch Allyn Protocol, Inc II Jun-23-2009
113 Welch Allyn Protocol, Inc I Mar-10-2009
114 Welch Allyn Protocol, Inc I Mar-10-2009
115 Welch Allyn Protocol, Inc I Mar-09-2009
116 Welch Allyn Protocol, Inc I Nov-06-2007
117 Welch Allyn Protocol, Inc I Sep-19-2007
118 ZOLL Medical Corporation II Mar-31-2014
119 ZOLL Medical Corporation II Sep-17-2012
120 ZOLL Medical Corporation II May-25-2011
121 ZOLL Medical Corporation, World Wide Headquarters II May-07-2010
122 ZOLL Medical Corporation, World Wide Headquarters II Sep-29-2009
123 ZOLL Medical Corporation, World Wide Headquarters I Apr-01-2009
124 ZOLL Medical Corporation, World Wide Headquarters II Jun-28-2008

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