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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 4
EDAN INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 6
GE HEALTHCARE FINLAND OY
  SUBSTANTIALLY EQUIVALENT 4
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 5
GLOBAL INSTRUMENTATION, LLC
  SUBSTANTIALLY EQUIVALENT 1
MASIMO CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
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 6
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 4

MDR Year MDR Reports MDR Events
2021 2423 2424
2022 1470 1487
2023 2255 2278
2024 2814 2823
2025 3813 3813
2026 2494 2494

Device Problems MDRs with this Device Problem Events in those MDRs
No Audible Alarm 2481 2488
Patient Device Interaction Problem 1793 1794
No Audible Prompt/Feedback 942 944
Communication or Transmission Problem 902 903
Defective Alarm 825 825
Display or Visual Feedback Problem 684 686
Output Problem 659 667
Device Alarm System 629 631
Application Program Problem 596 598
Unable to Obtain Readings 578 578
Incorrect Measurement 442 442
Unintended Application Program Shut Down 440 442
Unexpected Shutdown 417 417
Application Program Freezes or Fails to Launch 402 402
Wireless Communication Problem 336 337
No Display/Image 327 327
Power Problem 296 301
Erratic or Intermittent Display 258 260
Protective Measures Problem 257 263
Failure to Charge 238 238
Incorrect, Inadequate or Imprecise Result or Readings 215 216
Break 198 198
Charging Problem 181 181
Operating System Becomes Nonfunctional 137 137
Intermittent Communication Failure 127 130
Electrical /Electronic Property Problem 127 127
Insufficient Device Problem Information 125 125
Computer Software Problem 124 124
No Device Output 116 118
Failure to Power Up 111 111
Alarm Not Visible 106 107
Complete Loss of Power 100 101
Low Readings 94 94
Audible Prompt/Feedback Problem 91 91
Adverse Event Without Identified Device or Use Problem 91 91
Imprecise or Erratic Results 88 89
Mechanical Problem 83 83
High Readings 81 81
Material Integrity Problem 80 80
Failure to Calibrate 75 75
Loose or Intermittent Connection 73 73
Patient Data Problem 71 73
Fracture 70 70
Data Problem 65 65
Delayed Alarm 64 64
Image Display Error/Artifact 55 57
Signal Artifact/Noise 52 52
Appropriate Device Problem Term/Code Not Available 48 48
Detachment of Device or Device Component 43 43
Loss of Data 42 42

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 12032 12071
Skin Inflammation/ Irritation 2027 2027
Insufficient Information 700 703
Cardiac Arrest 191 191
Low Oxygen Saturation 82 87
Asystole 70 70
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 56 62
Tachycardia 52 52
Bradycardia 48 48
Unspecified Heart Problem 41 41
Blister 37 38
Arrhythmia 32 32
Hypoxia 29 29
High Blood Pressure/ Hypertension 21 21
Itching Sensation 19 19
Death 16 16
Low Blood Pressure/ Hypotension 16 16
No Consequences Or Impact To Patient 15 15
Ventricular Fibrillation 15 15
Erythema 14 14
Hemorrhage/Blood Loss/Bleeding 12 12
Respiratory Arrest 10 10
Bruise/Contusion 9 9
Burning Sensation 9 9
Burn(s) 9 10
Laceration(s) 9 9
Skin Burning Sensation 9 9
Skin Tears 8 8
Unspecified Tissue Injury 8 8
Apnea 7 7
Superficial (First Degree) Burn 6 6
Head Injury 6 6
No Patient Involvement 6 6
Swelling/ Edema 6 6
Localized Skin Lesion 5 5
Rash 5 5
Unspecified Respiratory Problem 5 5
Electric Shock 5 5
Brain Injury 5 5
Chest Pain 5 5
Skin Discoloration 5 5
Respiratory Failure 4 4
Cyanosis 4 4
Encephalopathy 4 4
Shock 4 4
Syncope/Fainting 3 3
Ischemia 3 3
Discomfort 3 3
Thrombosis/Thrombus 3 7
Hematoma 3 3

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 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 Medical Systems China Co., Ltd. II Sep-29-2023
14 GE Medical Systems Information Technologies Inc II May-28-2026
15 GE Medical Systems, LLC II Dec-19-2022
16 Masimo Corporation II Jul-02-2026
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 II Jan-22-2026
21 Philips North America II Sep-25-2024
22 Philips North America II Mar-27-2024
23 Philips North America II Jan-13-2024
24 Philips North America Llc II Jun-24-2026
25 Philips North America Llc II Jan-08-2026
26 Philips North America Llc II Dec-02-2025
27 Philips North America Llc II Feb-05-2025
28 Philips North America Llc II Dec-17-2024
29 Philips North America Llc II Oct-04-2024
30 Philips North America Llc II Sep-30-2024
31 Philips North America Llc II Aug-05-2024
32 Philips North America Llc II May-15-2024
33 Philips North America Llc II Apr-25-2024
34 Philips North America Llc II Sep-19-2023
35 Remote Diagnostic Technologies Ltd. II Jan-08-2026
36 Remote Diagnostic Technologies Ltd. II Jul-25-2025
37 Remote Diagnostic Technologies Ltd. II May-07-2025
38 Remote Diagnostic Technologies Ltd. II Apr-24-2025
39 Remote Diagnostic Technologies Ltd. II Sep-21-2023
40 Remote Diagnostic Technologies Ltd. II Apr-01-2023
41 Remote Diagnostic Technologies Ltd. II Jul-01-2021
42 Schiller, Ag II Sep-29-2025
43 Spacelabs Healthcare, Inc. II Oct-16-2025
44 Spacelabs Healthcare, Inc. II Jan-07-2025
45 Spacelabs Healthcare, Inc. II Jan-07-2025
46 Spacelabs Healthcare, Inc. II Aug-11-2022
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