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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device detector and alarm, arrhythmia
Regulation Description Arrhythmia detector and alarm (including ST-segment measurement and alarm).
Product CodeDSI
Regulation Number 870.1025
Device Class 2


Premarket Reviews
ManufacturerDecision
INFOBIONIC, INC.
  SUBSTANTIALLY EQUIVALENT 2
  1.  K230265  MoMe® ARC Wireless Ambulatory ECG Monitoring and D ...
  2.  K250356  MoMe ARC® Wireless Ambulatory ECG Monitoring and D ...
IRHYTHM TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDICALGORITHMICS S.A.
  SUBSTANTIALLY EQUIVALENT 1
PREVENTICE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
SMARTCARDIA SA
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 3084 3084
2021 3092 3093
2022 1638 1646
2023 1617 1621
2024 1320 1323
2025 728 728

Device Problems MDRs with this Device Problem Events in those MDRs
Under-Sensing 2544 2544
No Audible Alarm 2370 2373
Over-Sensing 1781 1781
No Audible Prompt/Feedback 1086 1087
Signal Artifact/Noise 748 748
Communication or Transmission Problem 683 685
Device Sensing Problem 565 565
Reset Problem 487 487
Adverse Event Without Identified Device or Use Problem 403 403
Migration or Expulsion of Device 326 326
Unable to Obtain Readings 313 313
Electromagnetic Interference 271 271
Failure to Interrogate 222 223
Defective Alarm 185 188
Device Alarm System 163 169
Battery Problem 134 134
Appropriate Term/Code Not Available 133 133
Inaudible or Unclear Audible Prompt/Feedback 127 127
Decreased Sensitivity 113 113
Inappropriate or Unexpected Reset 97 97
Overheating of Device 81 81
Device Difficult to Program or Calibrate 63 63
Device Displays Incorrect Message 60 60
Failure to Transmit Record 60 60
Premature Discharge of Battery 56 57
Data Problem 56 56
Melted 45 46
Audible Prompt/Feedback Problem 44 44
Output Problem 44 45
Patient Device Interaction Problem 43 45
Insufficient Information 41 42
Alarm Not Visible 35 35
Excessive Heating 34 34
Display or Visual Feedback Problem 33 33
Biocompatibility 32 32
Low Audible Alarm 32 32
Device-Device Incompatibility 29 29
Defective Component 29 29
Use of Device Problem 29 29
Defective Device 27 27
Patient-Device Incompatibility 25 25
Temperature Problem 24 25
Incorrect, Inadequate or Imprecise Result or Readings 24 25
No Device Output 23 23
Therapeutic or Diagnostic Output Failure 22 22
Incorrect Measurement 22 22
Smoking 19 19
Delayed Alarm 19 19
Protective Measures Problem 18 18
Human-Device Interface Problem 17 17

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7969 7980
No Consequences Or Impact To Patient 1146 1146
No Known Impact Or Consequence To Patient 1001 1001
No Patient Involvement 343 343
Insufficient Information 229 230
Unspecified Infection 192 192
Pain 134 134
Erosion 113 113
Skin Inflammation/ Irritation 61 61
Cardiac Arrest 56 56
Unspecified Heart Problem 54 55
Discomfort 40 40
Erythema 39 39
Hypersensitivity/Allergic reaction 38 38
Blister 26 26
Death 26 26
Impaired Healing 21 21
Low Oxygen Saturation 19 19
Superficial (First Degree) Burn 18 19
Swelling/ Edema 18 18
Rash 18 18
Itching Sensation 17 17
Bradycardia 17 17
Asystole 16 16
Hemorrhage/Bleeding 15 15
Burning Sensation 15 15
Arrhythmia 14 14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 14 14
Hypoxia 13 13
Purulent Discharge 13 13
Tachycardia 12 12
Burn(s) 11 11
Ventricular Fibrillation 10 10
Electric Shock 9 9
Skin Burning Sensation 8 8
Bacterial Infection 8 8
Twiddlers Syndrome 7 7
Bruise/Contusion 7 8
Chest Pain 7 7
Skin Tears 7 7
Atrial Fibrillation 7 7
Localized Skin Lesion 6 6
Wound Dehiscence 6 6
No Code Available 6 6
Diaphoresis 6 6
Hematoma 5 5
Local Reaction 5 5
Syncope/Fainting 5 5
Partial thickness (Second Degree) Burn 5 5
Cellulitis 5 5

Recalls
Manufacturer Recall Class Date Posted
1 GE Medical Systems Information Technologies Inc II Jun-10-2025
2 Philips North America, LLC II Jul-10-2020
3 Philips North America II Oct-08-2024
4 Philips North America II Oct-01-2024
5 Philips North America Llc II Dec-02-2025
6 Philips North America Llc II May-21-2021
7 Philips North America Llc II Dec-08-2020
8 Preventice Services, LLC II Jul-01-2020
9 Spacelabs Healthcare, Inc. II May-03-2023
10 iRhythm Technologies, Inc. II Nov-04-2022
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