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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
IRHYTHM TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDICALGORITHMICS S.A.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC
  SUBSTANTIALLY EQUIVALENT 1
MEMTEC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
NATIONAL CARDIAC, INC.
  SUBSTANTIALLY EQUIVALENT 1
PREVENTICE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
SMARTCARDIA SA
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 3485 3487
2020 3084 3084
2021 3092 3092
2022 1638 1640
2023 1618 1618
2024 1320 1320
2025 650 650

Device Problems MDRs with this Device Problem Events in those MDRs
Under-Sensing 3902 3902
Over-Sensing 2751 2751
No Audible Alarm 2529 2529
No Audible Prompt/Feedback 1277 1277
Signal Artifact/Noise 1166 1166
Device Sensing Problem 1118 1118
Communication or Transmission Problem 710 710
Adverse Event Without Identified Device or Use Problem 524 524
Reset Problem 518 518
Migration or Expulsion of Device 415 415
Unable to Obtain Readings 401 401
Electromagnetic Interference 394 394
Failure to Interrogate 281 281
Appropriate Term/Code Not Available 201 201
Device Alarm System 192 194
Defective Alarm 190 190
Battery Problem 179 179
Inaudible or Unclear Audible Prompt/Feedback 163 163
Decreased Sensitivity 157 157
Inappropriate or Unexpected Reset 102 102
Device Displays Incorrect Message 98 98
No Device Output 92 92
Premature Discharge of Battery 88 88
Overheating of Device 79 79
Defective Component 70 70
Data Problem 63 63
Device Difficult to Program or Calibrate 62 62
Failure to Transmit Record 61 61
Output Problem 60 60
Incorrect Measurement 53 53
Defective Device 53 53
Insufficient Information 52 52
Audible Prompt/Feedback Problem 50 50
Patient Device Interaction Problem 48 50
Display or Visual Feedback Problem 47 47
Melted 44 44
Alarm Not Visible 41 41
Therapeutic or Diagnostic Output Failure 37 37
Excessive Heating 34 34
Low Audible Alarm 33 33
Biocompatibility 32 32
Use of Device Problem 31 31
Device-Device Incompatibility 29 29
Patient-Device Incompatibility 27 27
Protective Measures Problem 26 26
Incorrect, Inadequate or Imprecise Result or Readings 26 26
Break 25 25
Temperature Problem 24 24
Smoking 20 20
Delayed Alarm 19 19

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7904 7904
No Known Impact Or Consequence To Patient 3881 3883
No Consequences Or Impact To Patient 1193 1193
No Patient Involvement 676 676
Unspecified Infection 255 255
Insufficient Information 229 229
Pain 182 182
Erosion 180 180
Skin Inflammation/ Irritation 61 61
Cardiac Arrest 59 59
Unspecified Heart Problem 54 54
Erythema 50 50
Discomfort 46 46
Death 41 41
Hypersensitivity/Allergic reaction 38 38
Impaired Healing 31 31
Blister 26 26
Low Oxygen Saturation 20 20
Rash 19 19
Superficial (First Degree) Burn 18 18
Bradycardia 18 18
Purulent Discharge 18 18
Burning Sensation 17 17
Arrhythmia 17 17
Itching Sensation 17 17
Swelling/ Edema 17 17
Asystole 16 16
Hemorrhage/Bleeding 16 16
Tachycardia 15 15
Hypoxia 15 15
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 14 14
Skin Irritation 13 13
Burn(s) 12 12
Bruise/Contusion 10 10
Electric Shock 10 10
No Code Available 10 10
Bacterial Infection 10 10
Ventricular Fibrillation 9 9
Chest Pain 8 8
Skin Tears 8 8
Hematoma 7 7
Cardiopulmonary Arrest 7 7
Atrial Fibrillation 7 7
Skin Burning Sensation 7 7
Twiddlers Syndrome 7 7
Loss of consciousness 7 7
Diaphoresis 6 6
Blood Loss 6 6
Localized Skin Lesion 6 6
Wound Dehiscence 6 6

Recalls
Manufacturer Recall Class Date Posted
1 GE Healthcare, LLC II Dec-20-2019
2 GE Healthcare, LLC II Oct-23-2019
3 GE Medical Systems Information Technologies Inc II Jun-10-2025
4 Philips North America, LLC II Jul-10-2020
5 Philips North America, LLC II Jun-01-2019
6 Philips North America II Oct-08-2024
7 Philips North America II Oct-01-2024
8 Philips North America Llc II May-21-2021
9 Philips North America Llc II Dec-08-2020
10 Preventice Services, LLC II Jul-01-2020
11 Spacelabs Healthcare, Inc. II May-03-2023
12 iRhythm Technologies, Inc. II Nov-04-2022
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