| Device |
automated external defibrillators (non-wearable) |
| Regulation Description |
Automated external defibrillator. |
| 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 shcok) 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 Code | MKJ |
| Regulation Number |
870.5310
|
|---|
| Device Class |
3
|
| Premarket Reviews |
|---|
| Manufacturer | Decision |
|---|
| ACCESS CARDIOSYSTEMS, INC. |
| |
SE SUBJECT TO TRACKING REG
|
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
|
7 |
| CARDIAC SCIENCE CORPORATION |
| |
SE SUBJECT TO TRACKING REG
|
2 |
| |
SUBSTANTIALLY EQUIVALENT
|
13 |
| COLORADO MEDTECH |
| |
SUBSTANTIALLY EQUIVALENT
|
1 |
| CONCORD |
| |
SUBSTANTIALLY EQUIVALENT
|
1 |
| CU MEDICAL SYSTEMS, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1 |
| DEFIBTECH, LLC |
| |
SE SUBJECT TO TRACKING REG
|
1 |
| |
SUBSTANTIALLY EQUIVALENT
|
5 |
| HEARTSINE TECHNOLOGIES, LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
4 |
| HEWLETT-PACKARD CO. |
| |
SE SUBJECT TO TRACKING REG
|
1 |
| |
SUBSTANTIALLY EQUIVALENT
|
5 |
| KATECHO, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
7 |
| LAERDAL MEDICAL CORP. |
| |
SUBSTANTIALLY EQUIVALENT
|
2 |
| LEONHARD LANG GMBH |
| |
SUBSTANTIALLY EQUIVALENT
|
4 |
| MARQUETTE |
| |
SUBSTANTIALLY EQUIVALENT
|
4 |
| MEDICAL RESEARCH LAB., INC. |
| |
SE SUBJECT TO TRACKING REG
|
3 |
| |
SUBSTANTIALLY EQUIVALENT
|
4 |
| MEDICOTEST A/S |
| |
SUBSTANTIALLY EQUIVALENT
|
1 |
| MEDTRONIC, INC. |
| |
SE SUBJECT TO TRACKING REG
|
2 |
| |
SUBSTANTIALLY EQUIVALENT
|
10 |
| PHILIPS MEDICAL SYSTEMS |
| |
SE SUBJECT TO TRACKING REG
|
2 |
| |
SUBSTANTIALLY EQUIVALENT
|
13 |
| PHYSIO-CONTROL, INC. |
| |
SE SUBJECT TO TRACKING REG
|
2 |
| |
SUBSTANTIALLY EQUIVALENT
|
14 |
| SURVIVALINK CORP. |
| |
SE SUBJECT TO TRACKING REG
|
1 |
| |
SUBSTANTIALLY EQUIVALENT
|
5 |
| WELCH ALLYN, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
2 |
| ZOLL MEDICAL CORPORATION |
| |
SE SUBJECT TO TRACKING REG
|
5 |
| |
SUBSTANTIALLY EQUIVALENT
|
42 |
|
| Device Problems |
| Failure to power-up |
927 |
| Device displays error message |
866 |
| Device inoperable |
634 |
| Failure to deliver energy |
575 |
| Loss of power |
401 |
| Failure to run on AC/DC |
378 |
| Use of Incorrect Control Settings |
247 |
| Failure to charge |
214 |
| No voice prompts |
76 |
| Failure to analyze rhythm |
69 |
| Device Issue |
64 |
| Device damaged prior to use |
54 |
| Premature discharge of battery |
53 |
| Failure to sense |
51 |
| Output energy incorrect |
43 |
| Device sensing issue |
39 |
| Device operates differently than expected |
39 |
| No display or display failure |
36 |
| Failure to shock or properly shock |
31 |
| Failure to discharge |
26 |
| EKG/ECG analysis, failure to perform |
24 |
| Low battery |
23 |
| Connection issue |
22 |
| Component(s), broken |
22 |
| Out-of-box failure |
21 |
| Power source issue |
21 |
| Inaudible voice prompts |
15 |
| Burn of device or device component |
15 |
| Blank screen |
13 |
| Difficult or delayed activation |
12 |
| Battery failure |
11 |
| Device emits odor |
11 |
| Inappropriate shock |
10 |
| Delayed charge time |
10 |
| Loose or intermittent connection |
10 |
| Detachment of device component |
9 |
| Inappropriate prompts |
9 |
| Failure to pace or properly pace |
8 |
| Smoking |
8 |
| Connection error |
7 |
| Battery issue |
7 |
| Charging issue |
6 |
| Incorrect interpretation of rhythm |
6 |
| Fumes or vapors |
5 |
| Failure to read input signal |
5 |
| Alarm system, failure of message-leads off |
5 |
| Use of Device Issue |
5 |
| Aborted charge |
5 |
| Volume accuracy issue |
5 |
| Self-activation or keying |
4 |
| Device remains activated |
4 |
| Alarm, no lead |
4 |
| Component falling |
4 |
| Arcing at electrodes |
4 |
| Component missing |
4 |
| Component(s), overheating of |
4 |
| Electrode(s), failure of |
3 |
| Failure to fire |
3 |
| Inaccurate synchronization |
3 |
| Foreign material |
3 |
| Intermittent shock |
3 |
| No device output |
3 |
| Incorrect display |
3 |
| Not audible alarm |
3 |
| Failure to calibrate |
3 |
| Component(s), worn |
3 |
| Erratic display |
3 |
| Difficult to deploy |
2 |
| Invalid sensing |
2 |
| No Known Device Problem |
2 |
| Output issue |
2 |
| No Information |
2 |
| Charred |
2 |
| Difficult to position |
2 |
| Output, low |
2 |
| Fire |
2 |
| Energy output to patient tissue incorrect |
2 |
| Cable break |
2 |
| Material separation |
2 |
| Motion detector failure |
2 |
| Sensing intermittently |
2 |
| Shock, failure to advise |
2 |
| Output, high |
1 |
| Performance |
1 |
| Sticking |
1 |
| Device stops intermittently |
1 |
| Loss of threshold |
1 |
| Leak |
1 |
| Misconnection |
1 |
| False alarm |
1 |
| Conductivity |
1 |
| Fuse, blown |
1 |
| Improper or incorrect procedure or method |
1 |
| Electro-static discharge |
1 |
| Electrical shorting |
1 |
| Foreign material present in device |
1 |
| Improper device output |
1 |
| Tears, rips, holes in device, device material |
1 |
| Bent |
1 |
| Handrest break |
1 |
| Total Device Problems |
5262 |
|
| Recalls |
| |
2007 |
2008 |
2009 |
2010 |
2011 |
2012 |
2013 |
| Class I |
3 |
0 |
5 |
5 |
1 |
2 |
0 |
| Class II |
6 |
12 |
11 |
17 |
7 |
5 |
5 |
| Class III |
0 |
1 |
0 |
1 |
1 |
0 |
0 |
|
| Recalls |
| Manufacturer |
Recall Class |
Date Posted |
| 1 |
BatteryZone, Inc. |
II |
Dec-22-2007 |
| 2 |
Cardiac Science Corporation |
I |
Feb-27-2012 |
| 3 |
Cardiac Science Corporation |
II |
Sep-19-2011 |
| 4 |
Cardiac Science Corporation |
II |
Aug-03-2011 |
| 5 |
Cardiac Science Corporation |
II |
Dec-10-2010 |
| 6 |
Cardiac Science Corporation |
II |
Jun-21-2010 |
| 7 |
Cardiac Science Corporation |
II |
May-26-2010 |
| 8 |
Cardiac Science Corporation |
I |
Apr-27-2010 |
| 9 |
Cardiac Science Corporation |
II |
Apr-06-2010 |
| 10 |
Cardiac Science Corporation |
I |
Mar-04-2010 |
| 11 |
Cardiac Science Corporation |
II |
Feb-25-2009 |
| 12 |
Cardiac Science Corporation |
II |
Sep-17-2008 |
| 13 |
Cardiac Science Corporation |
III |
May-21-2008 |
| 14 |
ConMed Corporation |
II |
May-13-2013 |
| 15 |
Defibtech LLC |
I |
Jun-10-2010 |
| 16 |
Defibtech, LLC |
I |
May-16-2011 |
| 17 |
Defibtech, LLC |
II |
Oct-18-2010 |
| 18 |
Defibtech, LLC |
I |
Mar-08-2007 |
| 19 |
Exocomm Tech Grp |
II |
Jan-26-2008 |
| 20 |
Heartsine Technologies, Limited |
I |
Oct-27-2012 |
| 21 |
Leonhard Lang Gmbh |
II |
Sep-24-2009 |
| 22 |
Medtronic Emergency Response Systems, Inc. |
II |
Jun-21-2007 |
| 23 |
Medtronic Emergency Response Systems, Inc. |
II |
Mar-29-2007 |
| 24 |
Philips Healthcare Inc. |
II |
Apr-29-2013 |
| 25 |
Philips Healthcare Inc. |
II |
Feb-21-2013 |
| 26 |
Philips Healthcare Inc. |
II |
Oct-04-2012 |
| 27 |
Philips Healthcare Inc. |
II |
Sep-10-2012 |
| 28 |
Philips Healthcare Inc. |
II |
Jul-11-2012 |
| 29 |
Philips Healthcare Inc. |
II |
Jun-27-2012 |
| 30 |
Philips Healthcare Inc. |
II |
Mar-08-2011 |
| 31 |
Philips Healthcare Inc. |
II |
Nov-08-2010 |
| 32 |
Philips Healthcare Inc. |
II |
Aug-27-2010 |
| 33 |
Philips Healthcare Inc. |
II |
May-24-2010 |
| 34 |
Philips Healthcare Inc. |
II |
Apr-09-2010 |
| 35 |
Philips Healthcare Inc. |
II |
Apr-08-2010 |
| 36 |
Philips Healthcare Inc. |
II |
Mar-15-2010 |
| 37 |
Philips Healthcare Inc. |
II |
Dec-23-2009 |
| 38 |
Philips Healthcare Inc. |
II |
Nov-09-2009 |
| 39 |
Philips Healthcare Inc. |
II |
Jul-24-2009 |
| 40 |
Philips Healthcare Inc. |
II |
Jun-02-2009 |
| 41 |
Philips Healthcare Inc. |
II |
May-19-2009 |
| 42 |
Philips Medical Systems |
II |
Nov-29-2010 |
| 43 |
Philips Medical Systems |
II |
Nov-26-2010 |
| 44 |
Philips Medical Systems |
III |
Nov-22-2010 |
| 45 |
Philips Medical Systems |
II |
Jun-28-2010 |
| 46 |
Philips Medical Systems |
II |
Mar-23-2010 |
| 47 |
Philips Medical Systems |
II |
Dec-08-2009 |
| 48 |
Philips Medical Systems |
II |
Sep-25-2008 |
| 49 |
Philips Medical Systems |
II |
Jul-09-2008 |
| 50 |
Philips Medical Systems |
II |
Oct-25-2007 |
| 51 |
Philips Medical Systems |
II |
Aug-07-2007 |
| 52 |
Philips Medical Systems |
II |
Mar-22-2007 |
| 53 |
Philips Medical Systems North America Co. Phillips |
II |
Jan-04-2013 |
| 54 |
Physio Control, Inc. |
II |
Apr-10-2013 |
| 55 |
Physio Control, Inc. |
II |
Jul-26-2011 |
| 56 |
Physio Control, Inc. |
III |
Jun-22-2011 |
| 57 |
Physio Control, Inc. |
II |
Mar-18-2011 |
| 58 |
Physio Control, Inc. |
II |
Mar-04-2011 |
| 59 |
Physio Control, Inc. |
I |
Jul-01-2010 |
| 60 |
Physio Control, Inc. |
I |
Apr-21-2010 |
| 61 |
Physio Control, Inc. |
II |
Feb-22-2010 |
| 62 |
Physio Control, Inc. |
I |
Sep-14-2009 |
| 63 |
Physio Control, Inc. |
II |
Oct-30-2008 |
| 64 |
Physio Control, Inc. |
II |
Sep-21-2008 |
| 65 |
Physio Control, Inc. |
II |
Sep-16-2008 |
| 66 |
Physio Control, Inc. |
II |
Sep-11-2008 |
| 67 |
Physio Control, Inc. |
II |
Aug-24-2008 |
| 68 |
Physio Control, Inc. |
II |
Mar-29-2008 |
| 69 |
Siemens Medical Solutions USA, Inc. |
II |
Feb-15-2008 |
| 70 |
Welch Allyn Protocol, Inc |
II |
Jul-06-2009 |
| 71 |
Welch Allyn Protocol, Inc |
II |
Jun-23-2009 |
| 72 |
Welch Allyn Protocol, Inc |
I |
Mar-10-2009 |
| 73 |
Welch Allyn Protocol, Inc |
I |
Mar-10-2009 |
| 74 |
Welch Allyn Protocol, Inc |
I |
Mar-09-2009 |
| 75 |
Welch Allyn Protocol, Inc |
I |
Nov-06-2007 |
| 76 |
Welch Allyn Protocol, Inc |
I |
Sep-19-2007 |
| 77 |
ZOLL Medical Corporation |
II |
Sep-17-2012 |
| 78 |
ZOLL Medical Corporation |
II |
May-25-2011 |
| 79 |
ZOLL Medical Corporation, World Wide Headquarters |
II |
May-07-2010 |
| 80 |
ZOLL Medical Corporation, World Wide Headquarters |
II |
Sep-29-2009 |
| 81 |
ZOLL Medical Corporation, World Wide Headquarters |
I |
Apr-01-2009 |
| 82 |
ZOLL Medical Corporation, World Wide Headquarters |
II |
Jun-28-2008 |
|
|
|
