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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 1
CAF MEDICAL SOLUTIONS INC.
  SUBSTANTIALLY EQUIVALENT 2
DRAEGER MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 5
EDAN INSTRUMENTS INC.
  SUBSTANTIALLY EQUIVALENT 1
EDAN INSTRUMENTS, INC
  SUBSTANTIALLY EQUIVALENT 2
EDAN INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 4
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 4
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 MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4

MDR Year MDR Reports MDR Events
2020 1714 1716
2021 2423 2423
2022 1470 1480
2023 2253 2253
2024 2814 2816
2025 3061 3061

Device Problems MDRs with this Device Problem Events in those MDRs
No Audible Alarm 2106 2110
Patient Device Interaction Problem 1284 1284
Communication or Transmission Problem 1052 1052
No Audible Prompt/Feedback 840 840
Device Alarm System 832 834
Output Problem 711 711
Defective Alarm 699 700
Display or Visual Feedback Problem 657 657
Application Program Problem 615 615
Unable to Obtain Readings 484 484
Unintended Application Program Shut Down 388 388
Adverse Event Without Identified Device or Use Problem 386 386
Power Problem 380 380
Unexpected Shutdown 363 363
Application Program Freezes, Becomes Nonfunctional 354 354
No Display/Image 351 352
Protective Measures Problem 304 305
Wireless Communication Problem 278 278
Incorrect, Inadequate or Imprecise Result or Readings 204 204
Failure to Charge 203 203
Break 184 184
Erratic or Intermittent Display 174 174
Computer Software Problem 153 153
Electrical /Electronic Property Problem 133 133
Alarm Not Visible 129 129
Charging Problem 129 129
Therapeutic or Diagnostic Output Failure 123 123
Incorrect Measurement 122 122
Failure to Power Up 119 119
Intermittent Communication Failure 117 118
Insufficient Information 115 115
Audible Prompt/Feedback Problem 107 107
Operating System Becomes Nonfunctional 105 105
No Device Output 101 103
Complete Loss of Power 100 100
Mechanical Problem 87 87
Patient Data Problem 77 77
Data Problem 74 74
Inaudible or Unclear Audible Prompt/Feedback 73 73
Device Displays Incorrect Message 70 71
Loose or Intermittent Connection 70 74
Low Readings 62 64
Material Integrity Problem 62 62
Appropriate Term/Code Not Available 59 59
Failure to Calibrate 58 58
Defective Component 57 57
Use of Device Problem 56 56
Computer Operating System Problem 55 55
Delayed Alarm 53 53
Device Fell 50 50

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 10199 10204
Skin Inflammation/ Irritation 1547 1547
Insufficient Information 665 670
No Known Impact Or Consequence To Patient 597 597
No Consequences Or Impact To Patient 278 278
Cardiac Arrest 190 190
No Patient Involvement 117 117
Death 107 107
Low Oxygen Saturation 77 81
Asystole 61 61
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 56 60
Tachycardia 40 40
Unspecified Heart Problem 40 40
Bradycardia 39 39
Blister 37 37
Skin Irritation 36 36
Arrhythmia 28 28
High Blood Pressure/ Hypertension 24 24
Hypoxia 22 22
Itching Sensation 19 19
Cardiopulmonary Arrest 17 17
Ventricular Fibrillation 16 16
Erythema 14 14
Low Blood Pressure/ Hypotension 13 13
Hemorrhage/Bleeding 12 12
Burning Sensation 11 11
Respiratory Arrest 10 10
Laceration(s) 10 10
Bruise/Contusion 10 10
Skin Burning Sensation 9 9
Burn(s) 8 8
Apnea 7 7
Skin Tears 7 7
Fall 6 6
Superficial (First Degree) Burn 6 6
Brain Injury 5 5
Unspecified Respiratory Problem 5 5
Rash 5 5
Head Injury 5 5
Localized Skin Lesion 5 5
Chest Pain 4 4
Injury 4 4
Shock 4 4
Unspecified Tissue Injury 4 4
Swelling/ Edema 4 4
Hematoma 4 4
Ventricular Tachycardia 4 4
Loss of consciousness 4 4
No Code Available 4 4
Electric Shock 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 Feb-18-2020
10 GE Healthcare Finland Oy II Nov-07-2025
11 GE Healthcare Finland Oy II Jun-21-2024
12 GE Healthcare, LLC II Jul-23-2021
13 GE Healthcare, LLC II Aug-04-2020
14 GE Healthcare, LLC II Jun-24-2020
15 GE Medical Systems China Co., Ltd. II Sep-29-2023
16 GE Medical Systems, LLC II Dec-19-2022
17 Mindray DS USA, Inc. dba Mindray North America II Sep-25-2025
18 Nihon Kohden America Inc II Jun-06-2024
19 Philips North America, LLC II Mar-30-2021
20 Philips North America, LLC II Jul-23-2020
21 Philips North America, LLC II Jul-23-2020
22 Philips North America, LLC II Apr-23-2020
23 Philips North America II Sep-25-2024
24 Philips North America II Mar-27-2024
25 Philips North America II Jan-13-2024
26 Philips North America Llc II Feb-05-2025
27 Philips North America Llc II Dec-17-2024
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 Jul-25-2025
35 Remote Diagnostic Technologies Ltd. II May-07-2025
36 Remote Diagnostic Technologies Ltd. II Apr-24-2025
37 Remote Diagnostic Technologies Ltd. II Sep-21-2023
38 Remote Diagnostic Technologies Ltd. II Apr-01-2023
39 Remote Diagnostic Technologies Ltd. II Jul-01-2021
40 Schiller, Ag II Sep-29-2025
41 Spacelabs Healthcare, Inc. II Oct-16-2025
42 Spacelabs Healthcare, Inc. II Jan-07-2025
43 Spacelabs Healthcare, Inc. II Jan-07-2025
44 Spacelabs Healthcare, Inc. II Aug-11-2022
45 Spacelabs Healthcare, Inc. II Jun-04-2020
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