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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
ALIVECOR, INC.
  SUBSTANTIALLY EQUIVALENT 1
CAF MEDICAL SOLUTIONS INC.
  SUBSTANTIALLY EQUIVALENT 2
DRAEGER MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 5
EDAN INSTRUMENTS, INC
  SUBSTANTIALLY EQUIVALENT 2
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 1462 1462
2020 1714 1714
2021 2423 2423
2022 1470 1470
2023 2252 2252
2024 2022 2024

Device Problems MDRs with this Device Problem Events in those MDRs
No Audible Alarm 1535 1535
Communication or Transmission Problem 1121 1121
Device Alarm System 948 948
Patient Device Interaction Problem 704 704
Output Problem 671 671
No Audible Prompt/Feedback 662 662
Display or Visual Feedback Problem 598 598
Application Program Problem 565 565
Defective Alarm 497 497
Adverse Event Without Identified Device or Use Problem 393 393
Power Problem 378 378
Unintended Application Program Shut Down 334 334
Protective Measures Problem 314 314
No Display/Image 302 302
Unable to Obtain Readings 287 287
Unexpected Shutdown 238 238
Application Program Freezes, Becomes Nonfunctional 234 234
Wireless Communication Problem 201 201
Incorrect, Inadequate or Imprecise Result or Readings 179 179
Therapeutic or Diagnostic Output Failure 157 157
Computer Software Problem 139 139
Computer Operating System Problem 129 129
No Device Output 125 127
Alarm Not Visible 118 118
Electrical /Electronic Property Problem 118 118
Device Displays Incorrect Message 107 107
Failure to Power Up 106 106
Defective Component 102 102
Failure to Charge 99 99
Audible Prompt/Feedback Problem 98 98
Insufficient Information 94 94
Incorrect Measurement 93 93
Intermittent Communication Failure 92 92
Erratic or Intermittent Display 88 88
Complete Loss of Power 87 87
Inaudible or Unclear Audible Prompt/Feedback 83 83
Appropriate Term/Code Not Available 79 79
Mechanical Problem 78 78
Break 77 77
Nonstandard Device 75 75
Patient Data Problem 72 72
Loose or Intermittent Connection 71 71
Charging Problem 69 69
Defective Device 66 66
Device Fell 61 61
Data Problem 60 60
Use of Device Problem 52 52
Overheating of Device 49 49
Loss of Data 46 46
Inappropriate or Unexpected Reset 46 46

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7304 7304
No Known Impact Or Consequence To Patient 1302 1302
Skin Inflammation/ Irritation 963 963
No Consequences Or Impact To Patient 761 761
Insufficient Information 498 500
No Patient Involvement 216 216
Death 197 197
Cardiac Arrest 171 171
Low Oxygen Saturation 81 81
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 54 54
Asystole 46 46
Skin Irritation 41 41
Blister 35 35
Tachycardia 33 33
Cardiopulmonary Arrest 30 30
Unspecified Heart Problem 30 30
Bradycardia 27 27
Arrhythmia 26 26
Hypoxia 21 21
Itching Sensation 19 19
Patient Problem/Medical Problem 14 14
Ventricular Fibrillation 13 13
Erythema 13 13
Burning Sensation 11 11
Hemorrhage/Bleeding 11 11
Laceration(s) 11 11
Loss of consciousness 10 10
Injury 9 9
Skin Burning Sensation 9 9
High Blood Pressure/ Hypertension 9 9
Low Blood Pressure/ Hypotension 9 9
No Code Available 9 9
Burn(s) 8 8
Ventricular Tachycardia 8 8
Loss Of Pulse 7 7
Fall 7 7
Skin Tears 7 7
Bruise/Contusion 7 7
Respiratory Arrest 6 6
Apnea 6 6
Head Injury 5 5
Localized Skin Lesion 5 5
Unspecified Respiratory Problem 5 5
Superficial (First Degree) Burn 5 5
Cyanosis 5 5
Unspecified Tissue Injury 4 4
Electric Shock 4 4
Respiratory Failure 4 4
Rash 4 4
Diminished Pulse Pressure 3 3

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 Jun-25-2024
8 Draeger Medical Systems, Inc. II Apr-27-2023
9 Edan Diagnostics II Feb-18-2020
10 GE Healthcare Finland Oy II Jun-21-2024
11 GE Healthcare, LLC II Jul-23-2021
12 GE Healthcare, LLC II Aug-04-2020
13 GE Healthcare, LLC II Jun-24-2020
14 GE Medical Systems China Co., Ltd. II Sep-29-2023
15 GE Medical Systems, LLC II Dec-19-2022
16 Nihon Kohden America Inc II Jun-06-2024
17 Philips North America, LLC II Mar-30-2021
18 Philips North America, LLC II Jul-23-2020
19 Philips North America, LLC II Jul-23-2020
20 Philips North America, LLC II Apr-23-2020
21 Philips North America, LLC II Sep-19-2019
22 Philips North America, LLC III Jun-12-2019
23 Philips North America, LLC II May-13-2019
24 Philips North America, LLC II Mar-28-2019
25 Philips North America II Sep-25-2024
26 Philips North America II Mar-27-2024
27 Philips North America II Jan-13-2024
28 Philips North America Llc II Oct-04-2024
29 Philips North America Llc II Sep-30-2024
30 Philips North America Llc II Aug-05-2024
31 Philips North America Llc II May-15-2024
32 Philips North America Llc II Apr-25-2024
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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