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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)
Product CodeMHX
Regulation Number 870.1025
Device Class 2


Premarket Reviews
ManufacturerDecision
CAF MEDICAL SOLUTIONS INC.
  SUBSTANTIALLY EQUIVALENT 2
DRAEGER MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 4
EDAN INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 3
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 2
GE HEALTHCARE FINLAND OY
  SUBSTANTIALLY EQUIVALENT 7
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 5
MASIMO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
MORTARA INSTRUMENT, INC.
  SUBSTANTIALLY EQUIVALENT 1
NIHON KOHDEN CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
NIHON KOHDEN DIGITAL HEALTH SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
NORTH-VISION TECH. INC.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 2
PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
  SUBSTANTIALLY EQUIVALENT 2
PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH
  SUBSTANTIALLY EQUIVALENT 7
REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED
  SUBSTANTIALLY EQUIVALENT 1
REMOTE DIAGNOSTIC TECHNOLOGIES LTD.
  SUBSTANTIALLY EQUIVALENT 1
SCHILLER AG
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN COMEN MEDICAL INSTRUMENTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN COMEN MEDICAL INSTRUMENTS CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 7
SOTERA WIRELESS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZOLL MANUFACTURING CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
ZOLL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 2157 2157
2019 1463 1463
2020 1714 1714
2021 2421 2421
2022 1465 1465
2023 1765 1765

Device Problems MDRs with this Device Problem Events in those MDRs
No Audible Alarm 1321 1321
Communication or Transmission Problem 1078 1078
Device Alarm System 1010 1010
Nonstandard Device 733 733
Output Problem 664 664
Application Program Problem 564 564
Display or Visual Feedback Problem 544 544
No Audible Prompt/Feedback 522 522
Computer Operating System Problem 439 439
Defective Alarm 416 416
Adverse Event Without Identified Device or Use Problem 398 398
Power Problem 381 381
No Display/Image 349 349
Device Operates Differently Than Expected 348 348
Unintended Application Program Shut Down 322 322
Inappropriate or Unexpected Reset 318 318
Protective Measures Problem 310 310
Device Displays Incorrect Message 265 265
Patient Device Interaction Problem 229 229
Incorrect, Inadequate or Imprecise Result or Readings 180 180
Application Program Freezes, Becomes Nonfunctional 175 175
Unexpected Shutdown 158 158
Therapeutic or Diagnostic Output Failure 157 157
No Device Output 151 151
Unable to Obtain Readings 136 136
Wireless Communication Problem 131 131
Computer Software Problem 126 126
Defective Component 123 123
Alarm Not Visible 118 118
Electrical /Electronic Property Problem 110 110
Appropriate Term/Code Not Available 109 109
Reset Problem 102 102
Complete Loss of Power 98 98
Defective Device 94 94
Audible Prompt/Feedback Problem 90 90
Inaudible or Unclear Audible Prompt/Feedback 88 88
Insufficient Information 82 82
Application Interface Becomes Non-Functional Or Program Exits Abnormally 81 81
Incorrect Measurement 75 75
Intermittent Communication Failure 73 73
Patient Data Problem 71 71
Break 68 68
Mechanical Problem 65 65
Failure to Power Up 65 65
Device Fell 64 64
Data Problem 63 63
Loose or Intermittent Connection 63 63
Loss of Power 62 62
Use of Device Problem 54 54
Overheating of Device 51 51
Loss of Data 50 50
Device Sensing Problem 49 49
Device Issue 49 49
Device Inoperable 44 44
Operating System Becomes Nonfunctional 41 41
Patient-Device Incompatibility 40 40
Erratic or Intermittent Display 40 40
Connection Problem 39 39
Device Operational Issue 34 34
Low Readings 34 34
Detachment of Device or Device Component 33 33
Failure to Analyze Signal 31 31
Failure to Discharge 30 30
Delayed Alarm 30 30
Failure to Charge 29 29
Fire 26 26
Application Network Problem 26 26
Signal Artifact/Noise 25 25
No Visual Prompts/Feedback 25 25
Intermittent Loss of Power 25 25
Use of Incorrect Control/Treatment Settings 23 23
Disconnection 22 22
Device Stops Intermittently 22 22
Improper or Incorrect Procedure or Method 20 20
Image Display Error/Artifact 20 20
High Readings 18 18
Failure to Sense 17 17
Battery Problem 15 15
Thermal Decomposition of Device 15 15
Inappropriate Audible Prompt/Feedback 14 14
Smoking 14 14
Device Handling Problem 14 14
Failure of Device to Self-Test 14 14
Human-Device Interface Problem 14 14
Temperature Problem 14 14
Compatibility Problem 13 13
False Alarm 13 13
Low Audible Alarm 12 12
Self-Activation or Keying 12 12
Failure to Calibrate 12 12
Noise, Audible 12 12
Component Missing 11 11
Charging Problem 11 11
Failure to Read Input Signal 11 11
Incorrect Interpretation of Signal 10 10
Electrical Power Problem 10 10
Human Factors Issue 9 9
Pumping Problem 9 9
Calibration Problem 9 9
Display Difficult to Read 8 8

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5422 5422
No Known Impact Or Consequence To Patient 2584 2584
No Consequences Or Impact To Patient 1357 1357
Skin Inflammation/ Irritation 490 490
Insufficient Information 405 405
Death 296 296
No Patient Involvement 281 281
Cardiac Arrest 165 165
Low Oxygen Saturation 89 89
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 41 41
Skin Irritation 41 41
Cardiopulmonary Arrest 35 35
Asystole 35 35
Patient Problem/Medical Problem 34 34
Blister 34 34
Injury 33 33
Arrhythmia 23 23
Bradycardia 22 22
Hypoxia 22 22
No Information 20 20
No Code Available 20 20
Itching Sensation 19 19
Unspecified Heart Problem 17 17
Tachycardia 16 16
Ventricular Fibrillation 16 16
Erythema 14 14
Hemorrhage/Bleeding 13 13
Ventricular Tachycardia 13 13
Laceration(s) 12 12
Bruise/Contusion 11 11
Burning Sensation 11 11
Loss of consciousness 11 11
Loss Of Pulse 10 10
Pressure Sores 10 10
Low Blood Pressure/ Hypotension 10 10
Burn(s) 9 9
High Blood Pressure/ Hypertension 9 9
Cyanosis 9 9
Fall 8 8
Apnea 8 8
Burn, Thermal 8 8
Skin Burning Sensation 8 8
Skin Tears 7 7
Abrasion 7 7
Electric Shock 6 6
Superficial (First Degree) Burn 6 6
Respiratory Arrest 5 5
Localized Skin Lesion 5 5
Head Injury 5 5
Rash 4 4
Unspecified Tissue Injury 4 4
Complaint, Ill-Defined 4 4
Respiratory Failure 4 4
Sudden Cardiac Death 3 3
Diminished Pulse Pressure 3 3
Unspecified Respiratory Problem 3 3
Respiratory Distress 3 3
Skin Discoloration 3 3
Brain Injury 3 3
Hematoma 3 3
Hemorrhage, Subarachnoid 2 2
Encephalopathy 2 2
Anoxia 2 2
Atrial Fibrillation 2 2
Chest Pain 2 2
Dyspnea 2 2
Non specific EKG/ECG Changes 2 2
Heart Failure 2 2
Vomiting 2 2
Tissue Damage 2 2
ST Segment Elevation 2 2
Myocardial Infarction 2 2
Overdose 2 2
Pain 2 2
Unspecified Kidney or Urinary Problem 2 2
Swelling/ Edema 2 2
Partial thickness (Second Degree) Burn 2 2
Full thickness (Third Degree) Burn 2 2
Blood Loss 2 2
Pallor 2 2
Irregular Pulse 2 2
Dizziness 2 2
Discomfort 2 2
Needle Stick/Puncture 1 1
Diabetic Ketoacidosis 1 1
Ventilator Dependent 1 1
Coma 1 1
Increased Respiratory Rate 1 1
Shaking/Tremors 1 1
Bronchospasm 1 1
Vascular System (Circulation), Impaired 1 1
Lethargy 1 1
Confusion/ Disorientation 1 1
Shock from Patient Lead(s) 1 1
Weight Changes 1 1
Complete Heart Block 1 1
Tissue Breakdown 1 1
Unintended Extubation 1 1
Decreased Appetite 1 1
Easy Bruising 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Datascope Corp. II Nov-01-2019
2 Draegar Medical Systems, Inc. II Apr-27-2022
3 Draegar Medical Systems, Inc. II Feb-10-2021
4 Draegar Medical Systems, Inc. II Nov-14-2019
5 Draegar Medical Systems, Inc. II Oct-31-2019
6 Draegar Medical Systems, Inc. II Mar-05-2019
7 Draegar Medical Systems, Inc. II May-14-2018
8 Draegar Medical Systems, Inc. II Apr-16-2018
9 Draegar Medical Systems, Inc. II Mar-09-2018
10 Draeger Medical Systems, Inc. II Apr-27-2023
11 Edan Diagnostics II Feb-18-2020
12 Edan Diagnostics II Oct-11-2018
13 GE Healthcare, LLC II Jul-23-2021
14 GE Healthcare, LLC II Aug-04-2020
15 GE Healthcare, LLC II Jun-24-2020
16 GE Healthcare, LLC II Dec-07-2018
17 GE Healthcare, LLC II Nov-29-2018
18 GE Medical Systems China Co., Ltd. II Sep-29-2023
19 GE Medical Systems, LLC II Dec-19-2022
20 Mindray DS USA, Inc. dba Mindray North America II Oct-17-2018
21 Philips Electronics North America Corporation II Aug-22-2018
22 Philips Electronics North America Corporation II Apr-06-2018
23 Philips Electronics North America Corporation II Mar-03-2018
24 Philips Electronics North America Corporation II Feb-28-2018
25 Philips North America, LLC II Mar-30-2021
26 Philips North America, LLC II Jul-23-2020
27 Philips North America, LLC II Jul-23-2020
28 Philips North America, LLC II Apr-23-2020
29 Philips North America, LLC II Sep-19-2019
30 Philips North America, LLC III Jun-12-2019
31 Philips North America, LLC II May-13-2019
32 Philips North America, LLC II Mar-28-2019
33 Philips North America Llc II Sep-19-2023
34 Remote Diagnostic Technologies Ltd. II Sep-21-2023
35 Remote Diagnostic Technologies Ltd. II Apr-01-2023
36 Remote Diagnostic Technologies Ltd. II Jul-01-2021
37 Spacelabs Healthcare, Inc. II Aug-11-2022
38 Spacelabs Healthcare, Inc. II Jun-04-2020
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