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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
ALIVECOR, INC.
  SUBSTANTIALLY EQUIVALENT 2
CAF MEDICAL SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 2
DRAEGER MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 5
EDAN INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 7
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1
GE HEALTHCARE FINLAND OY
  SUBSTANTIALLY EQUIVALENT 7
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 6
MASIMO CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
NIHON KOHDEN CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
NIHON KOHDEN DIGITAL HEALTH SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
  SUBSTANTIALLY EQUIVALENT 5
PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH
  SUBSTANTIALLY EQUIVALENT 7
REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED
  SUBSTANTIALLY EQUIVALENT 1
SCHILLER AG
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI DRAEGER MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN COMEN MEDICAL INSTRUMENTS CO.,LTD
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 5

MDR Year MDR Reports MDR Events
2020 1714 1716
2021 2423 2424
2022 1470 1487
2023 2255 2278
2024 2814 2823
2025 3813 3813
2026 1614 1614

Device Problems MDRs with this Device Problem Events in those MDRs
No Audible Alarm 2561 2572
Patient Device Interaction Problem 1648 1649
Communication or Transmission Problem 1110 1111
No Audible Prompt/Feedback 987 989
Device Alarm System 893 897
Defective Alarm 834 836
Output Problem 777 785
Display or Visual Feedback Problem 747 749
Application Program Problem 714 716
Unable to Obtain Readings 558 558
Unintended Application Program Shut Down 476 478
Application Program Freezes, Becomes Nonfunctional 418 418
Unexpected Shutdown 415 415
Power Problem 409 414
Adverse Event Without Identified Device or Use Problem 402 402
No Display/Image 391 392
Incorrect Measurement 338 338
Wireless Communication Problem 330 331
Protective Measures Problem 315 322
Incorrect, Inadequate or Imprecise Result or Readings 250 251
Erratic or Intermittent Display 239 241
Failure to Charge 234 234
Break 219 219
Charging Problem 167 167
Computer Software Problem 157 157
Electrical /Electronic Property Problem 146 146
Alarm Not Visible 134 135
Operating System Becomes Nonfunctional 133 133
Insufficient Information 127 127
Intermittent Communication Failure 127 131
Therapeutic or Diagnostic Output Failure 124 124
Failure to Power Up 123 123
No Device Output 120 122
Complete Loss of Power 116 117
Audible Prompt/Feedback Problem 108 108
Mechanical Problem 97 97
Low Readings 81 83
Patient Data Problem 80 82
Data Problem 78 78
Material Integrity Problem 77 77
Loose or Intermittent Connection 76 80
Device Displays Incorrect Message 73 74
Inaudible or Unclear Audible Prompt/Feedback 73 73
Failure to Calibrate 71 71
Computer Operating System Problem 69 69
High Readings 66 66
Erratic Results 64 65
Fracture 62 62
Delayed Alarm 61 61
Appropriate Term/Code Not Available 61 61

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 12069 12108
Skin Inflammation/ Irritation 1911 1911
Insufficient Information 739 744
No Known Impact Or Consequence To Patient 597 597
No Consequences Or Impact To Patient 278 278
Cardiac Arrest 204 204
No Patient Involvement 117 117
Death 107 107
Low Oxygen Saturation 96 101
Asystole 72 72
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 59 65
Bradycardia 50 50
Tachycardia 46 46
Unspecified Heart Problem 40 40
Blister 37 38
Arrhythmia 36 36
Skin Irritation 36 36
Hypoxia 29 29
High Blood Pressure/ Hypertension 24 24
Itching Sensation 19 19
Low Blood Pressure/ Hypotension 19 19
Cardiopulmonary Arrest 17 17
Ventricular Fibrillation 16 16
Erythema 14 14
Hemorrhage/Bleeding 13 13
Burning Sensation 11 11
Respiratory Arrest 11 11
Bruise/Contusion 10 10
Laceration(s) 10 10
Burn(s) 9 10
Skin Burning Sensation 9 9
Skin Tears 8 8
Apnea 7 7
Fall 7 7
Superficial (First Degree) Burn 6 6
Unspecified Respiratory Problem 5 5
Skin Discoloration 5 5
Rash 5 5
Loss of consciousness 5 5
Localized Skin Lesion 5 5
Head Injury 5 5
Brain Injury 5 5
Swelling/ Edema 5 5
Electric Shock 5 5
Cyanosis 5 5
Chest Pain 4 4
Hematoma 4 4
Ventricular Tachycardia 4 4
Respiratory Failure 4 4
Injury 4 4

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corporation II Apr-15-2025
2 Baxter Healthcare Corporation II Apr-14-2025
3 Contec Medical Systems Co., Ltd. II May-14-2025
4 Draegar Medical Systems, Inc. II Apr-27-2022
5 Draegar Medical Systems, Inc. II Feb-10-2021
6 Draeger Medical Systems, Inc. II Jan-30-2025
7 Draeger Medical Systems, Inc. II Jun-25-2024
8 Draeger Medical Systems, Inc. II Apr-27-2023
9 Edan Diagnostics II Jan-22-2026
10 Edan Diagnostics II Feb-18-2020
11 GE Healthcare Finland Oy II Nov-07-2025
12 GE Healthcare Finland Oy II Jun-21-2024
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 Medical Systems China Co., Ltd. II Sep-29-2023
17 GE Medical Systems, LLC II Dec-19-2022
18 Mindray DS USA, Inc. dba Mindray North America II Sep-25-2025
19 Nihon Kohden America Inc II Jun-06-2024
20 Philips North America, LLC II Mar-30-2021
21 Philips North America, LLC II Jul-23-2020
22 Philips North America, LLC II Jul-23-2020
23 Philips North America, LLC II Apr-23-2020
24 Philips North America II Jan-22-2026
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 Jan-08-2026
29 Philips North America Llc II Dec-02-2025
30 Philips North America Llc II Feb-05-2025
31 Philips North America Llc II Dec-17-2024
32 Philips North America Llc II Oct-04-2024
33 Philips North America Llc II Sep-30-2024
34 Philips North America Llc II Aug-05-2024
35 Philips North America Llc II May-15-2024
36 Philips North America Llc II Apr-25-2024
37 Philips North America Llc II Sep-19-2023
38 Remote Diagnostic Technologies Ltd. II Jan-08-2026
39 Remote Diagnostic Technologies Ltd. II Jul-25-2025
40 Remote Diagnostic Technologies Ltd. II May-07-2025
41 Remote Diagnostic Technologies Ltd. II Apr-24-2025
42 Remote Diagnostic Technologies Ltd. II Sep-21-2023
43 Remote Diagnostic Technologies Ltd. II Apr-01-2023
44 Remote Diagnostic Technologies Ltd. II Jul-01-2021
45 Schiller, Ag II Sep-29-2025
46 Spacelabs Healthcare, Inc. II Oct-16-2025
47 Spacelabs Healthcare, Inc. II Jan-07-2025
48 Spacelabs Healthcare, Inc. II Jan-07-2025
49 Spacelabs Healthcare, Inc. II Aug-11-2022
50 Spacelabs Healthcare, Inc. II Jun-04-2020
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