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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

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
0 0 0 0 0 0 0 0 0 0 2

Device Problems
Device operates differently than expected 4795
Device displays error message 2638
Failure to power-up 2339
Device inoperable 1437
Failure to run on AC/DC 1223
Self-activation or keying 951
Failure to deliver energy 759
Failure of device to self-test 748
Loss of power 619
Failure to charge 486
No Known Device Problem 447
No display or display failure 425
No voice prompts 322
Power source issue 280
Use of Incorrect Control Settings 250
Connection issue 222
Failure to discharge 210
Failure to shock or properly shock 191
Failure to sense 171
Failure to analyze rhythm 159
Device sensing issue 131
Premature discharge of battery 91
Output energy incorrect 89
Battery issue 89
Improper alarm 83
Inappropriate shock 83
Break 76
Device Issue 66
Computer operating system issue 63
Device damaged prior to use 54
Noise, Audible 54
Charging issue 42
Device stops intermittently 42
Unable to obtain readings 41
Failure to pace or properly pace 40
Low battery 40
Incorrect interpretation of rhythm 36
Grounding malfunction 26
Intermittent continuity 25
Aborted charge 25
EKG/ECG analysis, failure to perform 24
Inappropriate prompts 24
Loose or intermittent connection 24
Detachment of device component 23
Output issue 23
Communication or transmission issue 22
Component(s), broken 22
Defective component 21
Out-of-box failure 21
No Information 21
Burn of device or device component 20
Inaudible voice prompts 20
Use of Device Issue 19
Failure to Adhere or Bond 19
Device alarm system issue 18
Defective item 18
Difficult or delayed activation 18
Failure to read input signal 17
Failure to select signal 16
Device emits odor 16
Delayed charge time 16
Material fragmentation 15
Smoking 13
Blank screen 13
Component missing 13
Failure to deliver 13
Reset issue 13
Failure to calibrate 12
Improper device output 12
Inappropriate or unexpected reset 12
Material Distortion 12
Artifact 12
Application interface becomes non-functional or program exits abnormally 12
Inaccurate synchronization 12
Improper or incorrect procedure or method 11
Poor quality image 11
Image display error 11
Battery failure 11
Not audible alarm 11
Incorrect display 10
Unintended energization 10
Spark 10
Fire 9
Bent 8
Component falling 8
No device output 8
Mechanical issue 7
Fitting problem 7
Connection error 7
Failure to fire 7
Arcing at electrodes 7
Intermittent shock 6
Calibration issue 6
Naturally worn 6
Failure to shut off 6
Output below specifications 6
Erratic display 6
Electrical issue 6
Failure to deliver countershock 6
Volume accuracy issue 6
Total Device Problems 20661

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 3 0 5 5 1 2 0 4 0 1 4
Class II 6 12 11 17 7 5 10 19 8 6 1
Class III 0 1 0 1 1 0 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 Sep-12-2017
33 Leonhard Lang Medizintechnik GmbH I Oct-14-2016
34 Medtronic Emergency Response Systems, Inc. II Jun-21-2007
35 Medtronic Emergency Response Systems, Inc. II Mar-29-2007
36 Philips Electronics North America Corporation I Mar-24-2017
37 Philips Electronics North America Corporation II Sep-19-2016
38 Philips Electronics North America Corporation II Jun-02-2016
39 Philips Electronics North America Corporation II Nov-20-2015
40 Philips Electronics North America Corporation II Nov-13-2015
41 Philips Electronics North America Corporation II Aug-04-2015
42 Philips Healthcare Inc. II Jul-24-2013
43 Philips Healthcare Inc. II Apr-29-2013
44 Philips Healthcare Inc. II Feb-21-2013
45 Philips Healthcare Inc. II Oct-04-2012
46 Philips Healthcare Inc. II Sep-10-2012
47 Philips Healthcare Inc. II Jul-11-2012
48 Philips Healthcare Inc. II Jun-27-2012
49 Philips Healthcare Inc. II Mar-08-2011
50 Philips Healthcare Inc. II Nov-08-2010
51 Philips Healthcare Inc. II Aug-27-2010
52 Philips Healthcare Inc. II May-24-2010
53 Philips Healthcare Inc. II Apr-09-2010
54 Philips Healthcare Inc. II Apr-08-2010
55 Philips Healthcare Inc. II Mar-15-2010
56 Philips Healthcare Inc. II Dec-23-2009
57 Philips Healthcare Inc. II Nov-09-2009
58 Philips Healthcare Inc. II Jul-24-2009
59 Philips Healthcare Inc. II Jun-02-2009
60 Philips Healthcare Inc. II May-19-2009
61 Philips Medical Systems II Nov-29-2010
62 Philips Medical Systems II Nov-26-2010
63 Philips Medical Systems III Nov-22-2010
64 Philips Medical Systems II Jun-28-2010
65 Philips Medical Systems II Mar-23-2010
66 Philips Medical Systems II Dec-08-2009
67 Philips Medical Systems II Sep-25-2008
68 Philips Medical Systems II Jul-09-2008
69 Philips Medical Systems II Oct-25-2007
70 Philips Medical Systems II Aug-07-2007
71 Philips Medical Systems II Mar-22-2007
72 Philips Medical Systems North America Co. Phillips II Jan-04-2013
73 Philips Medical Systems North America Inc. II Mar-19-2014
74 Philips Medical Systems North America Inc. II Mar-19-2014
75 Philips Medical Systems, Inc. II Nov-10-2015
76 Philips Medical Systems, Inc. II Nov-05-2015
77 Philips Medical Systems, Inc. II Nov-03-2015
78 Philips Medical Systems, Inc. II Jan-13-2015
79 Philips Medical Systems, Inc. II Apr-09-2014
80 Philips Medical Systems, Inc. II Apr-09-2014
81 Philips Medical Systems, Inc. II Mar-12-2014
82 Philips Medical Systems, Inc. II Mar-07-2014
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-26-2014
88 Philips Medical Systems, Inc. II Feb-26-2014
89 Philips Medical Systems, Inc. II Feb-25-2014
90 Philips Medical Systems, Inc. II Dec-31-2013
91 Philips Medical Systems, Inc. II Dec-27-2013
92 Philips Medical Systems, Inc. II Dec-24-2013
93 Physio Control, Inc. II Jul-19-2013
94 Physio Control, Inc. II Apr-10-2013
95 Physio Control, Inc. II Jul-26-2011
96 Physio Control, Inc. III Jun-22-2011
97 Physio Control, Inc. II Mar-18-2011
98 Physio Control, Inc. II Mar-04-2011
99 Physio Control, Inc. I Jul-01-2010
100 Physio Control, Inc. I Apr-21-2010
101 Physio Control, Inc. II Feb-22-2010
102 Physio Control, Inc. I Sep-14-2009
103 Physio Control, Inc. II Oct-30-2008
104 Physio Control, Inc. II Sep-21-2008
105 Physio Control, Inc. II Sep-16-2008
106 Physio Control, Inc. II Sep-11-2008
107 Physio Control, Inc. II Aug-24-2008
108 Physio Control, Inc. II Mar-29-2008
109 Physio-Control, Inc. I Mar-03-2017
110 Physio-Control, Inc. I Feb-11-2017
111 Physio-Control, Inc. II Feb-07-2017
112 Physio-Control, Inc. II Dec-14-2016
113 Physio-Control, Inc. II Jun-29-2016
114 Physio-Control, Inc. II Jun-15-2016
115 Physio-Control, Inc. II May-23-2014
116 Siemens Medical Solutions USA, Inc. II Feb-15-2008
117 Welch Allyn Protocol, Inc II Jul-06-2009
118 Welch Allyn Protocol, Inc II Jun-23-2009
119 Welch Allyn Protocol, Inc I Mar-10-2009
120 Welch Allyn Protocol, Inc I Mar-10-2009
121 Welch Allyn Protocol, Inc I Mar-09-2009
122 Welch Allyn Protocol, Inc I Nov-06-2007
123 Welch Allyn Protocol, Inc I Sep-19-2007
124 ZOLL Medical Corporation II Mar-31-2014
125 ZOLL Medical Corporation II Sep-17-2012
126 ZOLL Medical Corporation II May-25-2011
127 ZOLL Medical Corporation, World Wide Headquarters II May-07-2010
128 ZOLL Medical Corporation, World Wide Headquarters II Sep-29-2009
129 ZOLL Medical Corporation, World Wide Headquarters I Apr-01-2009
130 ZOLL Medical Corporation, World Wide Headquarters II Jun-28-2008

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