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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
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 6
SCHILLER AG
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN COMEN MEDICAL INSTRUMENTS CO.,LTD
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2021 2423 2424
2022 1470 1487
2023 2255 2278
2024 2814 2823
2025 3813 3813
2026 1200 1200

Device Problems MDRs with this Device Problem Events in those MDRs
No Audible Alarm 2304 2315
Patient Device Interaction Problem 1590 1591
No Audible Prompt/Feedback 902 904
Communication or Transmission Problem 881 882
Defective Alarm 755 757
Display or Visual Feedback Problem 657 659
Output Problem 641 649
Device Alarm System 634 638
Application Program Problem 570 572
Unable to Obtain Readings 551 551
Unexpected Shutdown 397 397
Unintended Application Program Shut Down 395 397
Application Program Freezes, Becomes Nonfunctional 378 378
No Display/Image 326 327
Adverse Event Without Identified Device or Use Problem 316 316
Wireless Communication Problem 311 312
Incorrect Measurement 284 284
Power Problem 283 288
Protective Measures Problem 253 259
Failure to Charge 231 231
Erratic or Intermittent Display 225 227
Incorrect, Inadequate or Imprecise Result or Readings 203 204
Break 182 182
Charging Problem 164 164
Intermittent Communication Failure 124 128
Operating System Becomes Nonfunctional 123 123
Computer Software Problem 122 122
Electrical /Electronic Property Problem 120 120
Insufficient Information 118 118
Failure to Power Up 113 113
No Device Output 112 114
Alarm Not Visible 109 110
Audible Prompt/Feedback Problem 98 98
Complete Loss of Power 93 94
Mechanical Problem 81 81
Patient Data Problem 76 78
Loose or Intermittent Connection 73 77
Material Integrity Problem 73 73
Low Readings 71 73
Data Problem 68 68
Failure to Calibrate 68 68
High Readings 61 61
Fracture 60 60
Delayed Alarm 59 59
Erratic Results 57 58
Computer Operating System Problem 52 52
Image Display Error/Artifact 51 53
Appropriate Term/Code Not Available 48 48
Signal Artifact/Noise 48 48
Device Fell 44 45

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 11030 11069
Skin Inflammation/ Irritation 1820 1820
Insufficient Information 640 643
Cardiac Arrest 185 185
Low Oxygen Saturation 74 79
Asystole 66 66
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 55 61
Tachycardia 43 43
Bradycardia 42 42
Unspecified Heart Problem 40 40
Blister 37 38
Arrhythmia 29 29
Hypoxia 22 22
High Blood Pressure/ Hypertension 21 21
Itching Sensation 19 19
Death 16 16
No Consequences Or Impact To Patient 15 15
Low Blood Pressure/ Hypotension 15 15
Erythema 14 14
Ventricular Fibrillation 13 13
Hemorrhage/Bleeding 12 12
Respiratory Arrest 9 9
Bruise/Contusion 9 9
Skin Burning Sensation 9 9
Burning Sensation 9 9
Burn(s) 9 10
Laceration(s) 8 8
Skin Tears 8 8
Apnea 7 7
No Patient Involvement 6 6
Superficial (First Degree) Burn 6 6
Brain Injury 5 5
Head Injury 5 5
Electric Shock 5 5
Swelling/ Edema 5 5
Rash 5 5
Unspecified Respiratory Problem 5 5
Localized Skin Lesion 5 5
Respiratory Failure 4 4
Chest Pain 4 4
Unspecified Tissue Injury 4 4
Encephalopathy 4 4
Skin Discoloration 4 4
Shock 4 4
Ecchymosis 3 3
Coma 3 3
Thrombosis/Thrombus 3 7
Diminished Pulse Pressure 3 7
Syncope/Fainting 3 3
Cyanosis 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, LLC II Dec-19-2022
15 Mindray DS USA, Inc. dba Mindray North America II Sep-25-2025
16 Nihon Kohden America Inc II Jun-06-2024
17 Philips North America, LLC II Mar-30-2021
18 Philips North America II Jan-22-2026
19 Philips North America II Sep-25-2024
20 Philips North America II Mar-27-2024
21 Philips North America II Jan-13-2024
22 Philips North America Llc II Jan-08-2026
23 Philips North America Llc II Dec-02-2025
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 Jan-08-2026
33 Remote Diagnostic Technologies Ltd. II Jul-25-2025
34 Remote Diagnostic Technologies Ltd. II May-07-2025
35 Remote Diagnostic Technologies Ltd. II Apr-24-2025
36 Remote Diagnostic Technologies Ltd. II Sep-21-2023
37 Remote Diagnostic Technologies Ltd. II Apr-01-2023
38 Remote Diagnostic Technologies Ltd. II Jul-01-2021
39 Schiller, Ag II Sep-29-2025
40 Spacelabs Healthcare, Inc. II Oct-16-2025
41 Spacelabs Healthcare, Inc. II Jan-07-2025
42 Spacelabs Healthcare, Inc. II Jan-07-2025
43 Spacelabs Healthcare, Inc. II Aug-11-2022
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