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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device monitor, physiological, patient(with arrhythmia detection or alarms)
Regulation Description Arrhythmia detector and alarm (including ST-segment measurement and alarm).
Product CodeMHX
Regulation Number 870.1025
Device Class 2


Premarket Reviews
ManufacturerDecision
ADVANCED INSTUMENTATIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
CONTEX INTERNATIONAL TECHNOLOGIES (CANADA), INC.
  SUBSTANTIALLY EQUIVALENT 1
DRAEGER MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
EDAN INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 5
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 2
GE HEALTHCARE FINLAND OY
  SUBSTANTIALLY EQUIVALENT 3
GE MEDICAL SYSTEMS (CHINA) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
GUANGDONG BIOLIGHT MEDITECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
INTELESENS, LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
MORTARA INSTRUMENT, INC.
  SUBSTANTIALLY EQUIVALENT 3
NIHON KOHDEN CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
NORTH-VISION TECH. INC.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 7
PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH
  SUBSTANTIALLY EQUIVALENT 7
REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED
  SUBSTANTIALLY EQUIVALENT 1
REMOTE DIAGNOSTIC TECHNOLOGIES LTD
  SUBSTANTIALLY EQUIVALENT 1
REMOTE DIAGNOSTIC TECHNOLOGIES LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN COMEN MEDICAL INSTRUMENTS CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
  SUBSTANTIALLY EQUIVALENT 3
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 7
SOTERA WIRELESS, INC.
  SUBSTANTIALLY EQUIVALENT 1
TECHMEDIC DEVELOPMENT INTERNATIONAL B.V.
  SUBSTANTIALLY EQUIVALENT 1
WELCH ALLYN, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZOLL MANUFACTURING CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
ZOLL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 1104 1104
2017 1115 1115
2018 2157 2157
2019 1463 1463
2020 1714 1714
2021 1989 1989

Device Problems MDRs with this Device Problem Events in those MDRs
Device Alarm System 977 977
Communication or Transmission Problem 922 922
No Audible Alarm 914 914
Nonstandard Device 754 754
Device Operates Differently Than Expected 735 735
Device Displays Incorrect Message 566 566
No Display/Image 492 492
Computer Operating System Problem 481 481
Output Problem 481 481
Display or Visual Feedback Problem 376 376
Device Inoperable 375 375
Application Program Problem 374 374
Inappropriate or Unexpected Reset 317 317
Power Problem 283 283
Adverse Event Without Identified Device or Use Problem 266 266
Defective Alarm 259 259
Protective Measures Problem 242 242
No Audible Prompt/Feedback 233 233
Unintended Application Program Shut Down 215 215
No Device Output 156 156
Therapeutic or Diagnostic Output Failure 152 152
Application Interface Becomes Non-Functional Or Program Exits Abnormally 140 140
Incorrect, Inadequate or Imprecise Resultor Readings 132 132
Defective Component 130 130
Loss of Power 116 116
Wireless Communication Problem 101 101
Application Program Freezes, Becomes Nonfunctional 98 98
Defective Device 98 98
Alarm Not Visible 97 97
Appropriate Term/Code Not Available 96 96
Reset Problem 95 95
Computer Software Problem 91 91
Electrical /Electronic Property Problem 91 91
Inaudible or Unclear Audible Prompt/Feedback 89 89
Failure to Power Up 81 81
Break 79 79
Device Stops Intermittently 74 74
Mechanical Problem 70 70
Insufficient Information 68 68
Complete Loss of Power 66 66
Device Issue 66 66
Unexpected Shutdown 65 65
Overheating of Device 59 59
Device Operational Issue 58 58
Device Fell 53 53
Data Problem 51 51
Loss of Data 47 47
Connection Problem 43 43
Use of Device Problem 43 43
Operating System Becomes Nonfunctional 40 40
Patient Data Problem 40 40
Intermittent Communication Failure 36 36
Device Sensing Problem 33 33
Patient-Device Incompatibility 33 33
Improper or Incorrect Procedure or Method 32 32
Unable to Obtain Readings 32 32
Component Falling 30 30
Failure to Discharge 30 30
Incorrect Measurement 27 27
Fire 27 27
Thermal Decomposition of Device 26 26
Image Display Error/Artifact 25 25
Self-Activation or Keying 24 24
Audible Prompt/Feedback Problem 24 24
Temperature Problem 23 23
Use of Incorrect Control Settings 22 22
Erratic or Intermittent Display 21 21
Disconnection 20 20
Low Readings 20 20
Noise, Audible 20 20
Detachment of Device or Device Component 20 20
Improper Alarm 19 19
Loose or Intermittent Connection 18 18
Delayed Alarm 17 17
Failure to Sense 17 17
Intermittent Loss of Power 17 17
Application Network Problem 16 16
Battery Problem 14 14
Invalid Sensing 14 14
Telemetry Discrepancy 14 14
Smoking 14 14
Failure to Read Input Signal 14 14
False Reading From Device Non-Compliance 14 14
Melted 13 13
Component Missing 13 13
Incorrect Interpretation of Signal 13 13
Compatibility Problem 13 13
Human Factors Issue 12 12
High Readings 12 12
False Alarm 12 12
Signal Artifact/Noise 11 11
Human-Device Interface Problem 11 11
Improper Device Output 10 10
No Visual Prompts/Feedback 10 10
Pumping Problem 10 10
Detachment Of Device Component 10 10
Failure to Analyze Signal 10 10
Device Emits Odor 10 10
Intermittent Continuity 9 9
Electrical Power Problem 9 9

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 3961 3961
No Clinical Signs, Symptoms or Conditions 2314 2314
No Consequences Or Impact To Patient 1642 1642
Death 498 498
No Patient Involvement 378 378
Insufficient Information 204 204
Skin Inflammation/ Irritation 115 115
Cardiac Arrest 105 105
Low Oxygen Saturation 98 98
No Information 80 80
Injury 62 62
No Code Available 52 52
Cardiopulmonary Arrest 42 42
Ventricular Tachycardia 42 42
Skin Irritation 41 41
Patient Problem/Medical Problem 34 34
Bradycardia 30 30
Not Applicable 25 25
Burn(s) 19 19
Ventricular Fibrillation 18 18
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 16 16
Arrhythmia 15 15
Fall 14 14
Tachycardia 14 14
Loss of consciousness 14 14
Loss Of Pulse 14 14
Hypoxia 13 13
Cyanosis 12 12
Low Blood Pressure/ Hypotension 12 12
Pressure Sores 11 11
Abrasion 9 9
Bruise/Contusion 9 9
Burn, Thermal 9 9
Asystole 8 8
High Blood Pressure/ Hypertension 8 8
Respiratory Distress 7 7
Complaint, Ill-Defined 6 6
Electric Shock 5 5
Skin Discoloration 5 5
Overdose 5 5
Laceration(s) 5 5
Myocardial Infarction 4 4
Burning Sensation 4 4
Non specific EKG/ECG Changes 4 4
Blood Loss 4 4
Full thickness (Third Degree) Burn 4 4
Respiratory Arrest 4 4
Lead(s), Burn(s) From 3 3
Partial thickness (Second Degree) Burn 3 3
Sudden Cardiac Death 3 3
Respiratory Failure 3 3
Erythema 3 3
Head Injury 3 3
Hemorrhage/Bleeding 3 3
Atrial Fibrillation 3 3
Apnea 3 3
Pain 3 3
Seizures 3 3
ST Segment Elevation 2 2
Swelling 2 2
Misdiagnosis 2 2
Dizziness 2 2
Vomiting 2 2
Therapeutic Effects, Unexpected 2 2
Tissue Damage 2 2
Torsades-de-Pointes 2 2
Distress 2 2
Heart Failure 2 2
Brain Injury 2 2
Anoxia 2 2
Syncope 2 2
Congestive Heart Failure 2 2
Hemorrhage, Subarachnoid 2 2
Hematoma 2 2
Dyspnea 2 2
Pallor 2 2
Irregular Pulse 2 2
Complete Heart Block 2 2
Shock from Patient Lead(s) 2 2
Superficial (First Degree) Burn 2 2
Unspecified Respiratory Problem 2 2
Localized Skin Lesion 2 2
Unspecified Tissue Injury 2 2
Bronchospasm 1 1
Diminished Pulse Pressure 1 1
Lethargy 1 1
Vascular System (Circulation), Impaired 1 1
Unspecified Vascular Problem 1 1
Increased Respiratory Rate 1 1
Shaking/Tremors 1 1
Confusion/ Disorientation 1 1
Needle Stick/Puncture 1 1
Choking 1 1
Diabetic Ketoacidosis 1 1
Ventilator Dependent 1 1
Reaction 1 1
Numbness 1 1
Electro-Mechanical Dissociation 1 1
Electrocution 1 1
Fainting 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Datascope Corp. II Nov-01-2019
2 Draegar Medical Systems, Inc. II Feb-10-2021
3 Draegar Medical Systems, Inc. II Nov-14-2019
4 Draegar Medical Systems, Inc. II Oct-31-2019
5 Draegar Medical Systems, Inc. II Mar-05-2019
6 Draegar Medical Systems, Inc. II May-14-2018
7 Draegar Medical Systems, Inc. II Apr-16-2018
8 Draegar Medical Systems, Inc. II Mar-09-2018
9 Draegar Medical Systems, Inc. II Jul-14-2017
10 Draegar Medical Systems, Inc. II Apr-10-2017
11 Edan Diagnostics II Feb-18-2020
12 Edan Diagnostics II Oct-11-2018
13 Fukuda Denshi Co., Ltd. II Dec-06-2017
14 Fukuda Denshi USA, Inc. II Jan-16-2016
15 GE Healthcare, LLC II Jul-23-2021
16 GE Healthcare, LLC II Aug-04-2020
17 GE Healthcare, LLC II Jun-24-2020
18 GE Healthcare, LLC II Dec-07-2018
19 GE Healthcare, LLC II Nov-29-2018
20 GE Medical Systems Information Technologies, Inc. II Dec-06-2017
21 Mindray DS USA, Inc. dba Mindray North America II Oct-17-2018
22 Mindray DS USA, Inc. dba Mindray North America II Jun-27-2017
23 Mindray DS USA, Inc. dba Mindray North America II Oct-28-2016
24 Mindray DS USA, Inc. dba Mindray North America II Aug-16-2016
25 Mindray DS USA, Inc. dba Mindray North America II Apr-27-2016
26 Mindray DS USA, Inc. dba Mindray North America II Jan-29-2016
27 Nihon Kohden America Inc II Mar-20-2017
28 Philips Electronics North America Corporation II Aug-22-2018
29 Philips Electronics North America Corporation II Apr-06-2018
30 Philips Electronics North America Corporation II Mar-03-2018
31 Philips Electronics North America Corporation II Feb-28-2018
32 Philips Electronics North America Corporation II Dec-27-2017
33 Philips Electronics North America Corporation III Dec-20-2017
34 Philips Electronics North America Corporation II Jun-13-2017
35 Philips Electronics North America Corporation II May-31-2017
36 Philips Electronics North America Corporation II Feb-22-2017
37 Philips Electronics North America Corporation II Oct-20-2016
38 Philips Electronics North America Corporation II Aug-03-2016
39 Philips Electronics North America Corporation II Feb-23-2016
40 Philips Electronics North America Corporation II Feb-23-2016
41 Philips North America, LLC II Mar-30-2021
42 Philips North America, LLC II Jul-23-2020
43 Philips North America, LLC II Jul-23-2020
44 Philips North America, LLC II Apr-23-2020
45 Philips North America, LLC II Sep-19-2019
46 Philips North America, LLC III Jun-12-2019
47 Philips North America, LLC II May-13-2019
48 Philips North America, LLC II Mar-28-2019
49 Remote Diagnostic Technologies Ltd. II Jul-01-2021
50 Spacelabs Healthcare Inc II Nov-02-2016
51 Spacelabs Healthcare Inc II Sep-26-2016
52 Spacelabs Healthcare Inc II Aug-22-2016
53 Spacelabs Healthcare Inc II Mar-10-2016
54 Spacelabs Healthcare, Inc. II Jun-04-2020
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