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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
  1.  K192732  BodyGuardian Remote Monitoring System
SMARTCARDIA SA
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 3084 3084
2021 3092 3092
2022 1638 1638
2023 1669 1669
2024 1330 1330
2025 289 289

Device Problems MDRs with this Device Problem Events in those MDRs
Under-Sensing 2496 2496
No Audible Alarm 2294 2294
Over-Sensing 1744 1744
No Audible Prompt/Feedback 1071 1071
Signal Artifact/Noise 730 730
Communication or Transmission Problem 593 593
Device Sensing Problem 551 551
Reset Problem 456 456
Adverse Event Without Identified Device or Use Problem 390 390
Migration or Expulsion of Device 312 312
Unable to Obtain Readings 299 299
Electromagnetic Interference 264 264
Failure to Interrogate 212 212
Defective Alarm 173 173
Device Alarm System 159 159
Inaudible or Unclear Audible Prompt/Feedback 127 127
Appropriate Term/Code Not Available 125 125
Battery Problem 125 125
Decreased Sensitivity 111 111
Failure to Transmit Record 105 105
Inappropriate or Unexpected Reset 97 97
Overheating of Device 67 67
Device Difficult to Program or Calibrate 62 62
Device Displays Incorrect Message 59 59
Premature Discharge of Battery 52 52
Data Problem 52 52
Audible Prompt/Feedback Problem 44 44
Output Problem 41 41
Patient Device Interaction Problem 41 41
Insufficient Information 40 40
Melted 39 39
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
Device-Device Incompatibility 27 27
Patient-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
Wireless Communication Problem 17 17
Delayed Alarm 17 17
Computer Software Problem 17 17

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7586 7586
No Consequences Or Impact To Patient 1146 1146
No Known Impact Or Consequence To Patient 1001 1001
No Patient Involvement 343 343
Insufficient Information 224 224
Unspecified Infection 184 184
Pain 124 124
Erosion 109 109
Unspecified Heart Problem 101 101
Skin Inflammation/ Irritation 59 59
Cardiac Arrest 55 55
Discomfort 37 37
Hypersensitivity/Allergic reaction 37 37
Erythema 36 36
Blister 27 27
Death 26 26
Impaired Healing 21 21
Low Oxygen Saturation 19 19
Superficial (First Degree) Burn 17 17
Itching Sensation 16 16
Bradycardia 16 16
Asystole 16 16
Rash 15 15
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 14 14
Arrhythmia 14 14
Hemorrhage/Bleeding 14 14
Swelling/ Edema 13 13
Burning Sensation 12 12
Hypoxia 12 12
Tachycardia 12 12
Purulent Discharge 11 11
Burn(s) 9 9
Electric Shock 8 8
Ventricular Fibrillation 8 8
Bacterial Infection 8 8
Twiddlers Syndrome 7 7
Skin Tears 7 7
Atrial Fibrillation 6 6
Cellulitis 6 6
No Code Available 6 6
Diaphoresis 6 6
Chest Pain 6 6
Wound Dehiscence 6 6
Hematoma 5 5
Skin Erosion 5 5
Syncope/Fainting 5 5
Local Reaction 5 5
Bruise/Contusion 5 5
Fall 4 4
Cardiopulmonary Arrest 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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