Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)

Device Code: 874

Product Code(s): MHX

Device Classification Information

Device Type ID874
Device NameMonitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Regulation DescriptionArrhythmia Detector And Alarm (including ST-segment Measurement And Alarm).
Regulation Medical SpecialtyCardiovascular
Review PanelCardiovascular
Premarket Review Office Of Device Evaluation (ODE)
Division Of Cardiovascular Devices (DCD)
Cardiac Diagnostics Devices Branch (CDDB)
Submission Type510(k)
CFR Regulation Number870.1025 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeMHX
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID874
DeviceMonitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Product CodeMHX
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionArrhythmia Detector And Alarm (including ST-segment Measurement And Alarm).
CFR Regulation Number870.1025 [🔎]
Premarket Reviews
ManufacturerDecision
ADVANCED INSTRUMENTATIONS, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
ALERTWATCH LLC
 
SUBSTANTIALLY EQUIVALENT
 1
DRAEGER MEDICAL
 
SUBSTANTIALLY EQUIVALENT
 1
DRAEGER MEDICAL SYSTEMS, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
EDAN INSTRUMENTS, INC.
 
SUBSTANTIALLY EQUIVALENT
 4
FUKUDA DENSHI CO., LTD.
 
SUBSTANTIALLY EQUIVALENT
 2
FUKUDA DENSHI USA, INC.
 
SUBSTANTIALLY EQUIVALENT
 2
GE HEALTHCARE
 
SUBSTANTIALLY EQUIVALENT
 3
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
 
SUBSTANTIALLY EQUIVALENT
 2
GENERAL ELECTRIC CO.
 
SUBSTANTIALLY EQUIVALENT
 4
GUANGDONG BIOLIGHT MEDITECH CO., LTD.
 
SUBSTANTIALLY EQUIVALENT
 1
HANIN MEDICAL SERVICES CO. LTD
 
SUBSTANTIALLY EQUIVALENT
 1
HILL-ROM, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
INTELESENS LIMITED
 
SUBSTANTIALLY EQUIVALENT
 1
MEDTRONIC INC.
 
SUBSTANTIALLY EQUIVALENT
 1
MEDTRONIC, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
MID-LINK CONSULTING CO., LTD
 
SUBSTANTIALLY EQUIVALENT
 1
MINDRAY NORTH AMERICA
 
SUBSTANTIALLY EQUIVALENT
 1
MORTARA
 
SUBSTANTIALLY EQUIVALENT
 4
MORTARA INSTRUMENT, INC.
 
SUBSTANTIALLY EQUIVALENT
 4
NIHON KOHDEN
 
SUBSTANTIALLY EQUIVALENT
 1
NIHON KOHDEN CORP.
 
SUBSTANTIALLY EQUIVALENT
 1
NORTH-VISION TECH. INC.
 
SUBSTANTIALLY EQUIVALENT
 1
PHILIPS MEDICAL SYSTEMS
 
SUBSTANTIALLY EQUIVALENT
 12
PHILIPS MEDICAL SYSTEMS INTERNATIONAL BV
 
SUBSTANTIALLY EQUIVALENT
 6
PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.
 
SUBSTANTIALLY EQUIVALENT
 1
PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH
 
SUBSTANTIALLY EQUIVALENT
 5
REMOTE DIAGNOSTIC TECHNOLOGIES LTD
 
SUBSTANTIALLY EQUIVALENT
 2
REMOTE DIAGNOSTIC TECHNOLOGIES LTD.
 
SUBSTANTIALLY EQUIVALENT
 1
SHENZHEN MINDRAY BIOMEDICAL ELECTRONICS CO. LTD
 
SUBSTANTIALLY EQUIVALENT
 1
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
 
SUBSTANTIALLY EQUIVALENT
 5
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
 
SUBSTANTIALLY EQUIVALENT
 2
SHENZHEN MINDRAY BIO-MEIDCAL ELECTRONICS CO., LTD
 
SUBSTANTIALLY EQUIVALENT
 1
SOTERA WIRELESS, INC.
 
SUBSTANTIALLY EQUIVALENT
 2
SPACELABS HEALTHCARE
 
SUBSTANTIALLY EQUIVALENT
 2
SPACELABS HEALTHCARE LTD.
 
SUBSTANTIALLY EQUIVALENT
 2
TECHMEDIC DEVELOPMENT INTERNATIONAL B.V.
 
SUBSTANTIALLY EQUIVALENT
 1
WELCH ALLYN, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
ZOLL MANUFACTURING CORPORATION
 
SUBSTANTIALLY EQUIVALENT
 1
ZOLL MEDICAL CORPORATION
 
SUBSTANTIALLY EQUIVALENT
 1
Device Problems
Device Inoperable
 810
No Display / Image
 207
Device Operates Differently Than Expected
 176
Device Stops Intermittently
 99
Communication Or Transmission Problem
 87
Device Alarm System
 81
Wireless Communication Problem
 76
Device Displays Incorrect Message
74
No Audible Alarm
 68
Application Interface Becomes Non-Functional Or Program Exits Abnormally
 67
Device Issue
 67
Device Operational Issue
 58
Device Component Or Accessory
 53
Output Problem
 39
Application Program Problem
 33
Speaker
 32
Adverse Event Without Identified Device Or Use Problem
 31
Defective Alarm
 30
Incorrect, Inadequate Or Imprecise Result Or Readings
 29
Unintended Application Program Shut Down
 28
Appropriate Term/Code Not Available
 25
Loss Of Power
 25
Insufficient Information
 24
Power Supply
 22
Power Problem
 22
Failure To Power Up
 21
Alarm Not Visible
19
Complete Loss Of Power
 19
Device Sensing Problem
 18
Use Of Device Problem
 18
Improper Alarm
 16
Temperature Problem
 15
Failure To Service
 15
Electrical /Electronic Property Problem
 14
Use Of Incorrect Control Settings
 13
Incorrect Interpretation Of Signal
 13
Invalid Sensing
 12
Failure To Calibrate
 12
Human Factors Issue
 11
Protective Measures Problem
 11
Overheating Of Device
 11
Compatibility Problem
 10
Application Program Freezes, Becomes Nonfunctional
9
Display Or Visual Feedback Problem
 9
Failure To Analyze Signal
 9
Patient Data Problem
 9
Monitor
 9
Delayed Alarm
 8
Thermal Decomposition Of Device
 8
Alarm
 8
Display
 8
Unexpected Shutdown
 7
Human-Device Interface Problem
 7
Failure To Sense
7
Loss Of Data
 6
Defective Component
 6
Smoking
 6
Device Handling Problem
 6
Low Audible Alarm
 6
No Audible Prompt / Feedback
6
Erratic Or Intermittent Display
 5
Loose Or Intermittent Connection
 5
No Device Output
5
Application Network Problem
5
Low Readings
 5
Data Problem
 5
Radiofrequency Interference (RFI)
 5
Operating System Becomes Nonfunctional
 4
Inappropriate Or Unexpected Reset
 4
Computer Operating System Problem
 4
Power Cord
 4
Device Maintenance Issue
 4
Alarm, Volume
 4
Calibration Error
 4
Mechanical Problem
 3
Break
 3
Patient Device Interaction Problem
 3
Off-Label Use
 3
High Readings
 3
Incorrect Measurement
 3
Cable
 3
Improper Or Incorrect Procedure Or Method
 3
Improper Device Output
 3
Device Appears To Trigger Rejection
 3
Failure To Read Input Signal
 2
Display Difficult To Read
2
Battery Problem
 2
Medical Gas Supply Problem
 2
False Reading From Device Non-Compliance
 2
Application Program Version Or Upgrade Problem
 2
Sparking
 2
Melted
 2
Unintended Ejection
2
Maintenance Does Not Comply To Manufacturers Recommendations
 2
Inadequate Service
 2
Connection Problem
 2
Telemetry Discrepancy
 2
Inadequate Or Insufficient Training
 2
Detachment Of Device Component
 2
Image Display Error / Artifact
 2
Total Device Problems 2770
Recalls
Manufacturer Recall Class Date Posted
1
Draegar Medical Systems, Inc.
 II Mar-05-2019
2
Draegar Medical Systems, Inc.
 II May-14-2018
3
Draegar Medical Systems, Inc.
 II Apr-16-2018
4
Draegar Medical Systems, Inc.
 II Mar-09-2018
5
Draegar Medical Systems, Inc.
 II Jul-14-2017
6
Draegar Medical Systems, Inc.
 II Apr-10-2017
7
Draeger Medical Systems, Inc.
 II Jan-10-2014
8
Edan Diagnostics
 II Oct-11-2018
9
Fukuda Denshi Co., Ltd.
 II Dec-06-2017
10
Fukuda Denshi USA, Inc.
 II Jan-16-2016
11
GE Healthcare
 II May-12-2015
12
GE Healthcare, LLC
 II Dec-07-2018
13
GE Healthcare, LLC
 II Nov-29-2018
14
GE Healthcare, LLC
 II Oct-09-2014
15
GE Healthcare, LLC
 II Jul-24-2014
16
GE Healthcare, LLC
 II Jul-21-2014
17
GE Healthcare, LLC
 II Mar-11-2014
18
GE Healthcare, LLC
 II Mar-06-2014
19
GE Healthcare, LLC
 II Feb-14-2014
20
GE Healthcare, LLC
 II Feb-04-2014
21
GE Healthcare, LLC
 II Jan-28-2014
22
GE Healthcare, LLC
 II Jan-22-2014
23
GE Healthcare, LLC
 II Jan-14-2014
24
GE Healthcare, LLC
 II Jan-09-2014
25
GE Medical Systems Information Technologies, Inc.
 II Dec-06-2017
26
Mindray DS USA, Inc. Dba Mindray North America
 II Oct-17-2018
27
Mindray DS USA, Inc. Dba Mindray North America
 II Jun-27-2017
28
Mindray DS USA, Inc. Dba Mindray North America
 II Oct-28-2016
29
Mindray DS USA, Inc. Dba Mindray North America
 II Aug-16-2016
30
Mindray DS USA, Inc. Dba Mindray North America
 II Apr-27-2016
31
Mindray DS USA, Inc. Dba Mindray North America
 II Jan-29-2016
32
Mindray DS USA, Inc. Dba Mindray North America
 II Sep-04-2015
33
Mindray DS USA, Inc. Dba Mindray North America
 II May-26-2015
34
Mindray DS USA, Inc. Dba Mindray North America
 II Mar-16-2015
35
Mindray DS USA, Inc. Dba Mindray North America
 II Dec-19-2014
36
Mindray DS USA, Inc. Dba Mindray North America
 II Oct-21-2014
37
Mindray DS USA, Inc. Dba Mindray North America
 II Jul-16-2014
38
Mindray DS USA, Inc. Dba Mindray North America
 II May-13-2014
39
Mindray DS USA, Inc. Dba Mindray North America
 II Mar-07-2014
40
Mortara Instrument, Inc
 II Oct-22-2014
41
Nihon Kohden America Inc
 II Mar-20-2017
42
Nihon Kohden America Inc
 II Apr-29-2015
43
Nihon Kohden America Inc
 II Jul-02-2014
44
Philips Electronics North America Corporation
 II Aug-22-2018
45
Philips Electronics North America Corporation
 II Apr-06-2018
46
Philips Electronics North America Corporation
 II Mar-03-2018
47
Philips Electronics North America Corporation
 II Feb-28-2018
48
Philips Electronics North America Corporation
 II Dec-27-2017
49
Philips Electronics North America Corporation
 III Dec-20-2017
50
Philips Electronics North America Corporation
 II Jun-13-2017
51
Philips Electronics North America Corporation
 II May-31-2017
52
Philips Electronics North America Corporation
 II Feb-22-2017
53
Philips Electronics North America Corporation
 II Oct-20-2016
54
Philips Electronics North America Corporation
 II Aug-03-2016
55
Philips Electronics North America Corporation
 II Feb-23-2016
56
Philips Electronics North America Corporation
 II Feb-23-2016
57
Philips Healthcare Inc.
 II Jun-11-2014
58
Philips Medical Systems, Inc.
 II Dec-04-2015
59
Philips Medical Systems, Inc.
 II Oct-21-2014
60
Philips Medical Systems, Inc.
 II Jun-10-2014
61
Philips Medical Systems, Inc.
 II May-16-2014
62
Philips North America, LLC
 II Mar-28-2019
63
Spacelabs Healthcare Inc
 II Nov-02-2016
64
Spacelabs Healthcare Inc
 II Sep-26-2016
65
Spacelabs Healthcare Inc
 II Aug-22-2016
66
Spacelabs Healthcare Inc
 II Mar-10-2016
67
Spacelabs Healthcare Inc
 II May-13-2015
68
Spacelabs Healthcare Inc
 II Feb-24-2015
69
Spacelabs Healthcare Inc
 II Sep-25-2014
70
Spacelabs Healthcare Inc
 II Sep-04-2014
71
Spacelabs Healthcare Inc
 II Jun-23-2014
72
Spacelabs Healthcare, Llc
 II Jan-30-2014
TPLC Last Update: 2019-04-02 19:44:04
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