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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 1
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 3092
2022 1638 1638
2023 1669 1669
2024 1331 1331
2025 192 192

Device Problems MDRs with this Device Problem Events in those MDRs
Under-Sensing 2495 2495
No Audible Alarm 2258 2258
Over-Sensing 1742 1742
No Audible Prompt/Feedback 1062 1062
Signal Artifact/Noise 727 727
Communication or Transmission Problem 576 576
Device Sensing Problem 549 549
Reset Problem 448 448
Adverse Event Without Identified Device or Use Problem 387 387
Migration or Expulsion of Device 312 312
Unable to Obtain Readings 296 296
Electromagnetic Interference 261 261
Failure to Interrogate 212 212
Defective Alarm 167 167
Device Alarm System 159 159
Inaudible or Unclear Audible Prompt/Feedback 127 127
Appropriate Term/Code Not Available 125 125
Battery Problem 122 122
Decreased Sensitivity 111 111
Failure to Transmit Record 105 105
Inappropriate or Unexpected Reset 97 97
Overheating of Device 65 65
Device Difficult to Program or Calibrate 62 62
Device Displays Incorrect Message 59 59
Premature Discharge of Battery 52 52
Data Problem 51 51
Audible Prompt/Feedback Problem 44 44
Output Problem 41 41
Patient Device Interaction Problem 41 41
Insufficient Information 40 40
Melted 38 38
Alarm Not Visible 35 35
Biocompatibility 31 31
Low Audible Alarm 31 31
Display or Visual Feedback Problem 30 30
Defective Component 29 29
Use of Device Problem 28 28
Patient-Device Incompatibility 26 26
Device-Device Incompatibility 26 26
Defective Device 26 26
Excessive Heating 25 25
Temperature Problem 24 24
Incorrect, Inadequate or Imprecise Result or Readings 24 24
Therapeutic or Diagnostic Output Failure 22 22
No Device Output 21 21
Incorrect Measurement 21 21
Protective Measures Problem 18 18
Delayed Alarm 17 17
Wireless Communication Problem 16 16
Human-Device Interface Problem 16 16

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7499 7499
No Consequences Or Impact To Patient 1146 1146
No Known Impact Or Consequence To Patient 1001 1001
No Patient Involvement 343 343
Insufficient Information 221 221
Unspecified Infection 181 181
Pain 124 124
Erosion 109 109
Unspecified Heart Problem 101 101
Skin Inflammation/ Irritation 59 59
Cardiac Arrest 54 54
Discomfort 37 37
Hypersensitivity/Allergic reaction 37 37
Erythema 36 36
Blister 27 27
Death 26 26
Impaired Healing 21 21
Low Oxygen Saturation 17 17
Superficial (First Degree) Burn 16 16
Itching Sensation 16 16
Asystole 16 16
Bradycardia 15 15
Arrhythmia 14 14
Hemorrhage/Bleeding 14 14
Rash 14 14
Swelling/ Edema 13 13
Hypoxia 12 12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 12 12
Tachycardia 12 12
Burning Sensation 12 12
Purulent Discharge 11 11
Burn(s) 9 9
Bacterial Infection 8 8
Ventricular Fibrillation 8 8
Electric Shock 7 7
Skin Tears 7 7
Twiddlers Syndrome 7 7
No Code Available 6 6
Diaphoresis 6 6
Chest Pain 6 6
Cellulitis 6 6
Atrial Fibrillation 6 6
Wound Dehiscence 6 6
Skin Erosion 5 5
Hematoma 5 5
Local Reaction 5 5
Syncope/Fainting 5 5
Bruise/Contusion 5 5
Cardiopulmonary Arrest 4 4
Fall 4 4

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