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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
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 3091 3092
2022 1638 1646
2023 1615 1619
2024 1320 1323
2025 727 727
2026 255 255

Device Problems MDRs with this Device Problem Events in those MDRs
Under-Sensing 2568 2568
No Audible Alarm 2242 2245
Over-Sensing 1802 1802
Signal Artifact/Noise 757 757
No Audible Prompt/Feedback 742 743
Communication or Transmission Problem 713 715
Device Sensing Problem 577 577
Reset Problem 509 509
Adverse Event Without Identified Device or Use Problem 410 410
Migration or Expulsion of Device 335 335
Unable to Obtain Readings 326 326
Electromagnetic Interference 272 272
Failure to Interrogate 225 226
Defective Alarm 162 165
Battery Problem 138 138
Appropriate Device Problem Term/Code Not Available 138 138
Decreased Sensitivity 113 113
Device Alarm System 105 109
Inappropriate or Unexpected Reset 98 98
Overheating of Device 88 88
Device Difficult to Program or Calibrate 65 65
Data Problem 65 65
Failure to Transmit Record 58 58
Premature Discharge of Battery 56 57
Melted 51 51
Audible Prompt/Feedback Problem 41 41
Patient Device Interaction Problem 39 39
Excessive Heating 34 34
Biocompatibility 32 32
Low Audible Alarm 31 31
Alarm Not Visible 31 31
Output Problem 30 30
Incorrect Measurement 30 30
Device-Device Incompatibility 29 29
Insufficient Device Problem Information 27 28
Use of Device Problem 26 26
No Device Output 24 24
Temperature Problem 24 24
Patient-Device Incompatibility 23 23
Display or Visual Feedback Problem 20 20
Delayed Alarm 20 20
Human-Device Interface Problem 19 19
Incorrect, Inadequate or Imprecise Result or Readings 19 20
Smoking 19 19
Electrical /Electronic Property Problem 16 16
Computer Software Problem 16 16
Fire 15 15
Unintended Electrical Shock 14 14
Inaudible or Unclear Audible Prompt/Feedback 12 12
Positioning Problem 12 12

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 8186 8197
No Consequences Or Impact To Patient 1146 1146
No Known Impact Or Consequence To Patient 1001 1001
No Patient Involvement 343 343
Insufficient Information 238 239
Unspecified Infection 193 193
Pain 138 138
Erosion 117 117
Skin Inflammation/ Irritation 63 63
Cardiac Arrest 55 55
Unspecified Heart Problem 54 55
Discomfort 44 44
Hypersensitivity/Allergic reaction 42 42
Erythema 40 40
Blister 27 27
Death 26 26
Impaired Healing 21 21
Rash 21 21
Superficial (First Degree) Burn 20 21
Itching Sensation 20 20
Low Oxygen Saturation 19 19
Swelling/ Edema 18 18
Bradycardia 17 17
Burning Sensation 17 17
Asystole 16 16
Hemorrhage/Blood Loss/Bleeding 15 15
Arrhythmia 14 14
Purulent Discharge 14 14
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 14 14
Burn(s) 13 13
Hypoxia 13 13
Tachycardia 12 12
Ventricular Fibrillation 10 10
Electric Shock 9 9
Bacterial Infection 8 8
Chest Pain 8 8
Atrial Fibrillation 8 8
Skin Burning Sensation 8 8
Skin Tears 7 7
Twiddlers Syndrome 7 7
Bruise/Contusion 7 8
No Code Available 6 6
Diaphoresis 6 6
Skin Erosion 6 6
Numbness 6 6
Partial thickness (Second Degree) Burn 6 6
Hematoma 6 6
Wound Dehiscence 6 6
Localized Skin Lesion 6 6
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-01-2026
10 Spacelabs Healthcare, Inc. II Apr-07-2026
11 Spacelabs Healthcare, Inc. II May-03-2023
12 iRhythm Technologies, Inc. II Nov-04-2022
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