Automated External Defibrillators (non-wearable)

Device Code: 877

Product Code(s): MKJ

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 Sho

Device Classification Information

Device Type ID	877
Device Name	Automated External Defibrillators (non-wearable)
Regulation Description	Automated External Defibrillator System.
Regulation Medical Specialty	Cardiovascular
Review Panel	Cardiovascular
Premarket Review	Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Cardiac Diagnostics Devices Branch (CDDB)
Submission Type	PMA
CFR Regulation Number	870.5310 [🔎]
FDA Device Classification	Class 3 Medical Device
Product Code	MKJ
GMP Exempt	No
Summary MR	Eligible
Implanted Device	No
Life Support Device	No
Third Party Review	Not Third Party Eligible

Recognized Standards

3-129 AAMI ANSI EC53:2013
ECG Trunk Cables And Patient Leadwires
3-132 ISO 27185 First Edition 2012-02-15
Cardiac Rhythm Management Devices - Symbols To Be Used With Cardiac Rhythm Management Device Labels, And Information To Be Supplied - General Requirements

Total Product Life Cycle

Device Type ID	877
Device	Automated External Defibrillators (non-wearable)
Product Code	MKJ
FDA Device Classification	Class 3 Medical Device
Regulation Description	Automated External Defibrillator System.
CFR Regulation Number	870.5310 [🔎]

Premarket Reviews
Manufacturer	Decision
BIO-DETEK, INC.
	SUBSTANTIALLY EQUIVALENT	3
CARDIAC SCIENCE CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
DEFIBTECH, LLC
	SUBSTANTIALLY EQUIVALENT	1
HEARTSINE TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
HEARTSINE TECHNOLOGIES, LTD.
	SUBSTANTIALLY EQUIVALENT	1
LEONHARD LANG GMBH
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC INC.
	SUBSTANTIALLY EQUIVALENT	1
PHILIPS MEDICAL SYSTEMS
	SUBSTANTIALLY EQUIVALENT	1
PHILIPS MEDICAL SYSTEMS INTERNATIONAL BV
	SUBSTANTIALLY EQUIVALENT	1
PHYSIO-CONTROL, INC.
	SUBSTANTIALLY EQUIVALENT	1
R & D BATTERIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
ZELLER POWER PRODUCTS (BATTERY BEAST, LLC)
	SUBSTANTIALLY EQUIVALENT	1
ZOLL MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	5

Device Problems
Device Operates Differently Than Expected	5265
Failure To Power Up	3078
Device Displays Incorrect Message	2411
Failure Of Device To Self-Test	1293
Failure To Run On AC/DC	1189
Device Inoperable	1038
Self-Activation Or Keying	959
No Display / Image	856
Defibrillation Problem	525
Adverse Event Without Identified Device Or Use Problem	448
Failure To Charge	423
Power Problem	392
Failure To Deliver Energy	361
Loss Of Power	358
Unexpected Shutdown	357
Electrical /Electronic Property Problem	348
Connection Problem	313
Device Operational Issue	308
Failure To Discharge	296
No Audible Prompt / Feedback	274
Defective Device	231
Device Sensing Problem	209
Failure To Sense	206
Inappropriate Shock	185
Failure To Deliver Shock	156
Unable To Obtain Readings	149
Failure To Analyze Signal	143
Pacing Problem	139
Incorrect Interpretation Of Signal	116
Reset Problem	113
Energy Output Problem	112
Battery Problem	103
Grounding Malfunction	91
Improper Alarm	86
Premature Discharge Of Battery	82
Break	76
Battery	74
Computer Operating System Problem	63
Noise, Audible	59
Intermittent Loss Of Power	58
Inappropriate Or Unexpected Reset	49
Charging Problem	47
Switch, Push Button	47
Display	45
Device Stops Intermittently	43
Failure To Select Signal	40
Output Problem	38
Unintended Power Up	38
Use Of Device Problem	38
Aborted Charge	32
Output Below Specifications	31
Failure To Adhere Or Bond	29
Cable	29
Screen	28
Material Fragmentation	28
Display Or Visual Feedback Problem	26
Pad	26
Failure To Read Input Signal	26
Sparking	25
Intermittent Continuity	25
Defective Component	23
Communication Or Transmission Problem	22
Failure To Run On Battery	21
Insufficient Information	21
Connector	21
Device Alarm System	20
Erratic Or Intermittent Display	20
Appropriate Term/Code Not Available	18
Electrode	17
Low Battery	17
Inappropriate Audible Prompt / Feedback	17
Output Above Specifications	16
Delayed Charge Time	15
Loose Or Intermittent Connection	14
Detachment Of Device Component	14
Failure To Deliver	14
Patient Device Interaction Problem	13
Difficult Or Delayed Activation	13
Material Distortion	12
Failure To Shut Off	12
Device Contamination With Chemical Or Other Material	12
Signal Artifact	12
Application Interface Becomes Non-Functional Or Program Exits Abnormally	12
Failure To Capture	11
Improper Or Incorrect Procedure Or Method	11
Improper Device Output	11
Inaccurate Synchronization	11
Image Display Error / Artifact	11
Poor Quality Image	11
Mechanical Problem	11
Knob	10
Arcing Of Electrodes	10
Component Missing	9
Loss Of Or Failure To Bond	9
Failure To Calibrate	9
Fire	9
Component Or Accessory Incompatibility	9
Audible Prompt / Feedback	9
Thermal Decomposition Of Device	8
Fitting Problem	8
Total Device Problems	24176

Recalls
Manufacturer		Recall Class	Date Posted
1	Bio-Detek, Inc.	II	Oct-09-2014
2	Bio-Detek, Inc.	II	Sep-17-2014
3	Bio-Detek, Inc.	II	Sep-02-2014
4	Cardiac Science Corporation	II	Mar-09-2016
5	ConMed Corporation	II	Mar-24-2018
6	ConMed Corporation	I	Dec-04-2014
7	Covidien LLC	II	Sep-02-2015
8	Covidien LLC	I	Oct-15-2014
9	Heart Sync, Inc.	I	Dec-24-2014
10	Heartsine Technologies, Limited	II	Jul-24-2014
11	Leonhard Lang Gmbh	I	Dec-19-2014
12	Leonhard Lang Medizintechnik GmbH	I	Sep-12-2017
13	Leonhard Lang Medizintechnik GmbH	I	Oct-14-2016
14	Philips Electronics North America Corporation	II	May-30-2018
15	Philips Electronics North America Corporation	III	Mar-13-2018
16	Philips Electronics North America Corporation	I	Feb-08-2018
17	Philips Electronics North America Corporation	II	Jan-14-2018
18	Philips Electronics North America Corporation	I	Mar-24-2017
19	Philips Electronics North America Corporation	II	Sep-19-2016
20	Philips Electronics North America Corporation	II	Jun-02-2016
21	Philips Electronics North America Corporation	II	Nov-20-2015
22	Philips Electronics North America Corporation	II	Nov-13-2015
23	Philips Electronics North America Corporation	II	Aug-04-2015
24	Philips Electronics North America Corp.	II	Oct-18-2018
25	Philips Electronics North America Corp.	II	May-23-2018
26	Philips Medical Systems North America Inc.	II	Mar-19-2014
27	Philips Medical Systems North America Inc.	II	Mar-19-2014
28	Philips Medical Systems, Inc.	II	Nov-10-2015
29	Philips Medical Systems, Inc.	II	Nov-05-2015
30	Philips Medical Systems, Inc.	II	Nov-03-2015
31	Philips Medical Systems, Inc.	II	Jan-13-2015
32	Philips Medical Systems, Inc.	II	Apr-09-2014
33	Philips Medical Systems, Inc.	II	Apr-09-2014
34	Philips Medical Systems, Inc.	II	Mar-12-2014
35	Philips Medical Systems, Inc.	II	Mar-07-2014
36	Philips Medical Systems, Inc.	II	Feb-26-2014
37	Philips Medical Systems, Inc.	II	Feb-26-2014
38	Philips Medical Systems, Inc.	II	Feb-26-2014
39	Philips Medical Systems, Inc.	II	Feb-26-2014
40	Philips Medical Systems, Inc.	II	Feb-26-2014
41	Philips Medical Systems, Inc.	II	Feb-26-2014
42	Philips Medical Systems, Inc.	II	Feb-25-2014
43	Philips North America LLC	II	Dec-13-2018
44	Physio-Control Inc	I	Feb-26-2019
45	Physio-Control, Inc.	I	Jan-11-2018
46	Physio-Control, Inc.	I	Dec-12-2017
47	Physio-Control, Inc.	I	Mar-03-2017
48	Physio-Control, Inc.	I	Feb-11-2017
49	Physio-Control, Inc.	II	Feb-07-2017
50	Physio-Control, Inc.	II	Dec-14-2016
51	Physio-Control, Inc.	II	Jun-29-2016
52	Physio-Control, Inc.	II	Jun-15-2016
53	Physio-Control, Inc.	II	May-23-2014
54	ZOLL Medical Corporation	II	Mar-13-2018
55	ZOLL Medical Corporation	II	Mar-31-2014

TPLC Last Update: 2019-04-02 19:44:17