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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 7
  1.  K202336  Patient Monitor
  2.  K220308  Patient Monitor: RespArray
  3.  K232694  Central Monitoring System (MFM-CMS)
  4.  K232962  Patient Monitor (iX10, iX12, iX15)
  5.  K240320  Patient Monitor (RespArray)
  6.  K250179  Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX1 ...
  7.  K251508  Telemetry Monitor (iT30, iT50)
GE HEALTHCARE FINLAND OY
  SUBSTANTIALLY EQUIVALENT 4
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 6
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 2982 2982

Device Problems MDRs with this Device Problem Events in those MDRs
No Audible Alarm 2562 2569
Patient Device Interaction Problem 1866 1867
No Audible Prompt/Feedback 969 971
Communication or Transmission Problem 912 913
Defective Alarm 847 847
Display or Visual Feedback Problem 693 695
Output Problem 682 690
Device Alarm System 644 646
Unable to Obtain Readings 612 612
Application Program Problem 612 614
Incorrect Measurement 488 488
Unintended Application Program Shut Down 462 464
Unexpected Shutdown 421 421
Application Program Freezes or Fails to Launch 413 413
Wireless Communication Problem 359 360
No Display/Image 332 332
Power Problem 297 302
Protective Measures Problem 264 270
Erratic or Intermittent Display 263 265
Failure to Charge 245 245
Incorrect, Inadequate or Imprecise Result or Readings 222 223
Break 211 211
Charging Problem 182 182
Operating System Becomes Nonfunctional 145 145
Intermittent Communication Failure 132 135
Electrical /Electronic Property Problem 129 129
No Device Output 125 127
Insufficient Device Problem Information 125 125
Computer Software Problem 124 124
Failure to Power Up 111 111
Alarm Not Visible 107 108
Imprecise or Erratic Results 107 108
Low Readings 103 103
Complete Loss of Power 101 102
Adverse Event Without Identified Device or Use Problem 93 93
Audible Prompt/Feedback Problem 91 91
High Readings 85 85
Mechanical Problem 83 83
Failure to Calibrate 82 82
Material Integrity Problem 81 81
Fracture 75 75
Loose or Intermittent Connection 73 73
Patient Data Problem 71 73
Data Problem 67 67
Delayed Alarm 65 65
Image Display Error/Artifact 55 57
Signal Artifact/Noise 54 54
Appropriate Device Problem Term/Code Not Available 48 48
Detachment of Device or Device Component 44 44
Loss of Data 42 42

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 12433 12472
Skin Inflammation/ Irritation 2102 2102
Insufficient Information 708 711
Cardiac Arrest 194 194
Low Oxygen Saturation 85 90
Asystole 72 72
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 56 62
Tachycardia 53 53
Bradycardia 49 49
Unspecified Heart Problem 41 41
Blister 37 38
Arrhythmia 33 33
Hypoxia 30 30
High Blood Pressure/ Hypertension 21 21
Itching Sensation 19 19
Low Blood Pressure/ Hypotension 18 18
Death 16 16
Ventricular Fibrillation 16 16
No Consequences Or Impact To Patient 15 15
Erythema 14 14
Hemorrhage/Blood Loss/Bleeding 12 12
Respiratory Arrest 10 10
Laceration(s) 9 9
Skin Burning Sensation 9 9
Bruise/Contusion 9 9
Burning Sensation 9 9
Burn(s) 9 10
Skin Tears 8 8
Apnea 7 7
No Patient Involvement 6 6
Swelling/ Edema 6 6
Superficial (First Degree) Burn 6 6
Head Injury 6 6
Unspecified Tissue Injury 6 6
Electric Shock 5 5
Brain Injury 5 5
Chest Pain 5 5
Unspecified Respiratory Problem 5 5
Rash 5 5
Skin Discoloration 5 5
Localized Skin Lesion 5 5
Shock 4 4
Cyanosis 4 4
Respiratory Failure 4 4
Encephalopathy 4 4
Diminished Pulse Pressure 3 7
Ischemia 3 3
Thrombosis/Thrombus 3 7
Hematoma 3 3
Discomfort 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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