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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 1
EDAN INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 4
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
NIHON KOHDEN CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
NIHON KOHDEN DIGITAL HEALTH SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
  SUBSTANTIALLY EQUIVALENT 2
PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH
  SUBSTANTIALLY EQUIVALENT 6
REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED
  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 1
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 6
ZOLL MANUFACTURING CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 1463 1463
2020 1714 1714
2021 2421 2421
2022 1465 1465
2023 2232 2232
2024 895 895

Device Problems MDRs with this Device Problem Events in those MDRs
No Audible Alarm 1360 1360
Communication or Transmission Problem 1090 1090
Device Alarm System 912 912
Output Problem 642 642
No Audible Prompt/Feedback 590 590
Display or Visual Feedback Problem 551 551
Application Program Problem 550 550
Patient Device Interaction Problem 500 500
Defective Alarm 434 434
Adverse Event Without Identified Device or Use Problem 389 389
Power Problem 368 368
Unintended Application Program Shut Down 319 319
Protective Measures Problem 304 304
No Display/Image 269 269
Unable to Obtain Readings 227 227
Application Program Freezes, Becomes Nonfunctional 194 194
Unexpected Shutdown 188 188
Incorrect, Inadequate or Imprecise Result or Readings 160 160
Therapeutic or Diagnostic Output Failure 157 157
Wireless Communication Problem 143 143
Computer Operating System Problem 128 128
Computer Software Problem 128 128
No Device Output 122 122
Electrical /Electronic Property Problem 112 112
Alarm Not Visible 110 110
Device Displays Incorrect Message 107 107
Defective Component 102 102
Audible Prompt/Feedback Problem 93 93
Insufficient Information 84 84
Complete Loss of Power 84 84
Incorrect Measurement 83 83
Failure to Power Up 81 81
Inaudible or Unclear Audible Prompt/Feedback 81 81
Intermittent Communication Failure 78 78
Appropriate Term/Code Not Available 77 77
Nonstandard Device 75 75
Failure to Charge 75 75
Mechanical Problem 73 73
Erratic or Intermittent Display 72 72
Loose or Intermittent Connection 68 68
Defective Device 66 66
Patient Data Problem 66 66
Break 65 65
Device Fell 61 61
Data Problem 60 60
Use of Device Problem 51 51
Inappropriate or Unexpected Reset 46 46
Loss of Data 45 45
Overheating of Device 45 45
Charging Problem 43 43
Patient-Device Incompatibility 39 39
Delayed Alarm 35 35
Detachment of Device or Device Component 34 34
Connection Problem 34 34
Loss of Power 33 33
Device Sensing Problem 32 32
Low Readings 32 32
No Visual Prompts/Feedback 30 30
Intermittent Loss of Power 29 29
Operating System Becomes Nonfunctional 29 29
Image Display Error/Artifact 29 29
Failure to Analyze Signal 28 28
Disconnection 26 26
Signal Artifact/Noise 25 25
Fire 23 23
Application Network Problem 22 22
Battery Problem 19 19
Incomplete or Inadequate Connection 19 19
Reset Problem 18 18
Failure of Device to Self-Test 18 18
Failure to Calibrate 18 18
High Readings 18 18
Material Integrity Problem 17 17
Inappropriate Audible Prompt/Feedback 16 16
Low Audible Alarm 15 15
False Alarm 15 15
Use of Incorrect Control/Treatment Settings 14 14
No Tactile Prompts/Feedback 14 14
Improper or Incorrect Procedure or Method 13 13
Failure to Sense 12 12
Device Handling Problem 12 12
Temperature Problem 11 11
Smoking 11 11
Fitting Problem 11 11
Failure to Read Input Signal 10 10
Sparking 10 10
Human-Device Interface Problem 10 10
Pumping Problem 9 9
Noise, Audible 9 9
Material Split, Cut or Torn 9 9
Unintended Electrical Shock 9 9
Erratic Results 9 9
Calibration Problem 9 9
Electrical Power Problem 9 9
Crack 9 9
Failure to Discharge 8 8
Self-Activation or Keying 8 8
Component Missing 8 8
Display Difficult to Read 7 7
Poor Quality Image 7 7

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6419 6419
No Known Impact Or Consequence To Patient 1302 1302
No Consequences Or Impact To Patient 762 762
Skin Inflammation/ Irritation 760 760
Insufficient Information 452 452
No Patient Involvement 216 216
Death 197 197
Cardiac Arrest 161 161
Low Oxygen Saturation 72 72
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 49 49
Asystole 44 44
Skin Irritation 41 41
Blister 34 34
Cardiopulmonary Arrest 30 30
Tachycardia 29 29
Bradycardia 26 26
Arrhythmia 24 24
Unspecified Heart Problem 24 24
Hypoxia 21 21
Itching Sensation 19 19
Patient Problem/Medical Problem 14 14
Erythema 12 12
Ventricular Fibrillation 12 12
Laceration(s) 11 11
Hemorrhage/Bleeding 11 11
Burning Sensation 10 10
Loss of consciousness 10 10
No Code Available 9 9
Skin Burning Sensation 9 9
Injury 9 9
High Blood Pressure/ Hypertension 9 9
Low Blood Pressure/ Hypotension 8 8
Ventricular Tachycardia 8 8
Fall 7 7
Bruise/Contusion 7 7
Burn(s) 7 7
Skin Tears 7 7
Loss Of Pulse 7 7
Respiratory Arrest 6 6
Apnea 6 6
Head Injury 5 5
Localized Skin Lesion 5 5
Superficial (First Degree) Burn 5 5
Electric Shock 4 4
Respiratory Failure 4 4
Unspecified Tissue Injury 4 4
Unspecified Respiratory Problem 4 4
Cyanosis 4 4
Rash 4 4
Shock 3 3
Skin Discoloration 3 3
Brain Injury 3 3
Hematoma 3 3
No Information 3 3
Diminished Pulse Pressure 3 3
Irregular Pulse 2 2
Full thickness (Third Degree) Burn 2 2
Discomfort 2 2
Complaint, Ill-Defined 2 2
Burn, Thermal 2 2
Blood Loss 2 2
Swelling/ Edema 2 2
Unspecified Kidney or Urinary Problem 2 2
Encephalopathy 2 2
Dyspnea 2 2
Chest Pain 2 2
Atrial Fibrillation 2 2
Heart Failure 2 2
Respiratory Distress 2 2
ST Segment Elevation 2 2
Pain 2 2
Peeling 1 1
Pulmonary Edema 1 1
Failure of Implant 1 1
Swelling 1 1
Therapeutic Effects, Unexpected 1 1
Tissue Damage 1 1
Torsades-de-Pointes 1 1
Rupture 1 1
Anaphylactoid 1 1
Vomiting 1 1
Jaundice 1 1
Dizziness 1 1
Viral Infection 1 1
Pressure Sores 1 1
Anxiety 1 1
Distress 1 1
Malaise 1 1
Diabetic Ketoacidosis 1 1
Ventilator Dependent 1 1
Numbness 1 1
Coma 1 1
Abdominal Pain 1 1
Anaphylactic Shock 1 1
Aneurysm 1 1
Non specific EKG/ECG Changes 1 1
Ecchymosis 1 1
Electrocution 1 1
Eye Injury 1 1
Fainting 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 Draeger Medical Systems, Inc. II Apr-27-2023
8 Edan Diagnostics II Feb-18-2020
9 GE Healthcare, LLC II Jul-23-2021
10 GE Healthcare, LLC II Aug-04-2020
11 GE Healthcare, LLC II Jun-24-2020
12 GE Medical Systems China Co., Ltd. II Sep-29-2023
13 GE Medical Systems, LLC II Dec-19-2022
14 Philips North America, LLC II Mar-30-2021
15 Philips North America, LLC II Jul-23-2020
16 Philips North America, LLC II Jul-23-2020
17 Philips North America, LLC II Apr-23-2020
18 Philips North America, LLC II Sep-19-2019
19 Philips North America, LLC III Jun-12-2019
20 Philips North America, LLC II May-13-2019
21 Philips North America, LLC II Mar-28-2019
22 Philips North America II Mar-27-2024
23 Philips North America II Jan-13-2024
24 Philips North America Llc II Apr-25-2024
25 Philips North America Llc II Sep-19-2023
26 Remote Diagnostic Technologies Ltd. II Sep-21-2023
27 Remote Diagnostic Technologies Ltd. II Apr-01-2023
28 Remote Diagnostic Technologies Ltd. II Jul-01-2021
29 Spacelabs Healthcare, Inc. II Aug-11-2022
30 Spacelabs Healthcare, Inc. II Jun-04-2020
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