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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 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 5
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 3
PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH
  SUBSTANTIALLY EQUIVALENT 5
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 1714
2021 2423 2423
2022 1470 1470
2023 2255 2255
2024 2817 2819
2025 1255 1255

Device Problems MDRs with this Device Problem Events in those MDRs
No Audible Alarm 1694 1694
Patient Device Interaction Problem 1035 1035
Communication or Transmission Problem 987 987
Device Alarm System 788 788
No Audible Prompt/Feedback 753 753
Output Problem 665 665
Display or Visual Feedback Problem 599 599
Defective Alarm 590 590
Application Program Problem 549 549
Unable to Obtain Readings 396 396
Adverse Event Without Identified Device or Use Problem 371 371
Power Problem 350 350
Unintended Application Program Shut Down 324 324
Unexpected Shutdown 320 320
No Display/Image 313 313
Application Program Freezes, Becomes Nonfunctional 294 294
Protective Measures Problem 285 285
Wireless Communication Problem 233 233
Incorrect, Inadequate or Imprecise Result or Readings 178 178
Failure to Charge 167 167
Computer Software Problem 145 145
Erratic or Intermittent Display 139 139
Break 126 126
Therapeutic or Diagnostic Output Failure 122 122
Alarm Not Visible 116 116
Electrical /Electronic Property Problem 115 115
Failure to Power Up 110 110
Intermittent Communication Failure 108 108
Incorrect Measurement 106 106
Insufficient Information 104 104
Audible Prompt/Feedback Problem 100 100
No Device Output 94 96
Charging Problem 92 92
Complete Loss of Power 84 84
Mechanical Problem 77 77
Patient Data Problem 75 75
Operating System Becomes Nonfunctional 74 74
Inaudible or Unclear Audible Prompt/Feedback 72 72
Device Displays Incorrect Message 70 70
Loose or Intermittent Connection 68 68
Data Problem 65 65
Low Readings 58 58
Defective Component 57 57
Appropriate Term/Code Not Available 55 55
Delayed Alarm 50 50
Use of Device Problem 49 49
Device Fell 49 49
Computer Operating System Problem 47 47
Material Integrity Problem 46 46
Connection Problem 45 45

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 8758 8760
Skin Inflammation/ Irritation 1299 1299
No Known Impact Or Consequence To Patient 597 597
Insufficient Information 594 596
No Consequences Or Impact To Patient 278 278
Cardiac Arrest 180 180
No Patient Involvement 117 117
Death 107 107
Low Oxygen Saturation 68 68
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 55 55
Asystole 51 51
Blister 37 37
Skin Irritation 36 36
Tachycardia 36 36
Unspecified Heart Problem 35 35
Bradycardia 31 31
Arrhythmia 26 26
High Blood Pressure/ Hypertension 24 24
Hypoxia 20 20
Itching Sensation 19 19
Cardiopulmonary Arrest 17 17
Ventricular Fibrillation 15 15
Erythema 14 14
Burning Sensation 11 11
Hemorrhage/Bleeding 11 11
Bruise/Contusion 10 10
Laceration(s) 10 10
Respiratory Arrest 10 10
Skin Burning Sensation 9 9
Skin Tears 7 7
Apnea 7 7
Low Blood Pressure/ Hypotension 7 7
Superficial (First Degree) Burn 6 6
Fall 6 6
Burn(s) 6 6
Head Injury 5 5
Brain Injury 5 5
Unspecified Respiratory Problem 5 5
Localized Skin Lesion 5 5
Rash 5 5
Unspecified Tissue Injury 4 4
Ventricular Tachycardia 4 4
Swelling/ Edema 4 4
Hematoma 4 4
Patient Problem/Medical Problem 4 4
No Code Available 4 4
Encephalopathy 4 4
Loss of consciousness 4 4
Injury 4 4
Shock 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 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 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 Feb-05-2025
25 Philips North America Llc II Dec-17-2024
26 Philips North America Llc II Oct-04-2024
27 Philips North America Llc II Sep-30-2024
28 Philips North America Llc II Aug-05-2024
29 Philips North America Llc II May-15-2024
30 Philips North America Llc II Apr-25-2024
31 Philips North America Llc II Sep-19-2023
32 Remote Diagnostic Technologies Ltd. II May-07-2025
33 Remote Diagnostic Technologies Ltd. II Apr-24-2025
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 Jan-07-2025
38 Spacelabs Healthcare, Inc. II Jan-07-2025
39 Spacelabs Healthcare, Inc. II Aug-11-2022
40 Spacelabs Healthcare, Inc. II Jun-04-2020
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