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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
BOSTON SCIENTIFIC CARDIAC DIAGNOSTIC TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
INFOBIONIC, INC.
  SUBSTANTIALLY EQUIVALENT 2
IRHYTHM TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
SMARTCARDIA SA
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 3091 3092
2022 1638 1646
2023 1615 1619
2024 1320 1323
2025 727 727
2026 197 197

Device Problems MDRs with this Device Problem Events in those MDRs
No Audible Alarm 2239 2242
Under-Sensing 1478 1478
Over-Sensing 1014 1014
No Audible Prompt/Feedback 741 742
Communication or Transmission Problem 613 615
Reset Problem 430 430
Signal Artifact/Noise 424 424
Device Sensing Problem 320 320
Adverse Event Without Identified Device or Use Problem 305 305
Migration or Expulsion of Device 241 241
Unable to Obtain Readings 185 185
Defective Alarm 162 165
Electromagnetic Interference 158 158
Failure to Interrogate 153 154
Appropriate Device Problem Term/Code Not Available 106 106
Device Alarm System 104 108
Battery Problem 104 104
Inappropriate or Unexpected Reset 97 97
Overheating of Device 83 83
Failure to Transmit Record 58 58
Decreased Sensitivity 51 51
Melted 49 49
Data Problem 47 47
Audible Prompt/Feedback Problem 41 41
Premature Discharge of Battery 39 40
Device Difficult to Program or Calibrate 37 37
Patient Device Interaction Problem 35 35
Excessive Heating 33 33
Biocompatibility 32 32
Low Audible Alarm 31 31
Incorrect Measurement 30 30
Alarm Not Visible 30 30
Output Problem 28 28
Insufficient Device Problem Information 26 27
Temperature Problem 24 24
Device-Device Incompatibility 23 23
Use of Device Problem 23 23
No Device Output 22 22
Patient-Device Incompatibility 22 22
Delayed Alarm 20 20
Incorrect, Inadequate or Imprecise Result or Readings 19 20
Display or Visual Feedback Problem 19 19
Smoking 18 18
Human-Device Interface Problem 17 17
Fire 15 15
Electrical /Electronic Property Problem 15 15
Computer Software Problem 15 15
Unintended Electrical Shock 14 14
Inappropriate Audible Prompt/Feedback 12 12
Inaudible or Unclear Audible Prompt/Feedback 12 12

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7636 7647
Insufficient Information 196 197
Unspecified Infection 141 141
Pain 101 101
Erosion 75 75
No Patient Involvement 67 67
Skin Inflammation/ Irritation 61 61
Unspecified Heart Problem 54 55
Cardiac Arrest 50 50
Hypersensitivity/Allergic reaction 36 36
Erythema 31 31
Discomfort 27 27
Blister 26 26
Rash 19 19
Superficial (First Degree) Burn 18 19
Itching Sensation 18 18
Swelling/ Edema 17 17
Asystole 16 16
Low Oxygen Saturation 14 14
Hemorrhage/Blood Loss/Bleeding 14 14
Arrhythmia 13 13
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 13 13
Bradycardia 13 13
Hypoxia 13 13
Impaired Healing 12 12
Burning Sensation 12 12
Tachycardia 11 11
Burn(s) 10 10
Purulent Discharge 9 9
Electric Shock 9 9
Skin Burning Sensation 8 8
Ventricular Fibrillation 8 8
No Consequences Or Impact To Patient 7 7
Skin Tears 7 7
Twiddlers Syndrome 7 7
Wound Dehiscence 6 6
Localized Skin Lesion 6 6
Bacterial Infection 6 6
Atrial Fibrillation 6 6
Skin Erosion 6 6
Numbness 6 6
Hematoma 6 6
Chest Pain 6 6
Diaphoresis 6 6
Partial thickness (Second Degree) Burn 5 5
Bruise/Contusion 5 6
Syncope/Fainting 5 5
Medical device site infection 5 5
Local Reaction 5 5
Caustic/Chemical Burns 4 4

Recalls
Manufacturer Recall Class Date Posted
1 GE Medical Systems Information Technologies Inc II Jun-10-2025
2 Philips North America II Oct-08-2024
3 Philips North America II Oct-01-2024
4 Philips North America Llc II Dec-02-2025
5 Philips North America Llc II May-21-2021
6 Spacelabs Healthcare, Inc. II May-01-2026
7 Spacelabs Healthcare, Inc. II Apr-07-2026
8 Spacelabs Healthcare, Inc. II May-03-2023
9 iRhythm Technologies, Inc. II Nov-04-2022
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