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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
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
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 3483 3483
2020 3084 3084
2021 3092 3092
2022 1638 1638
2023 1669 1669
2024 1255 1255

Device Problems MDRs with this Device Problem Events in those MDRs
Under-Sensing 3861 3861
Over-Sensing 2710 2710
No Audible Alarm 2302 2302
No Audible Prompt/Feedback 1220 1220
Signal Artifact/Noise 1143 1143
Device Sensing Problem 1096 1096
Communication or Transmission Problem 597 597
Adverse Event Without Identified Device or Use Problem 510 510
Reset Problem 472 472
Migration or Expulsion of Device 399 399
Unable to Obtain Readings 384 384
Electromagnetic Interference 384 384
Failure to Interrogate 267 267
Appropriate Term/Code Not Available 195 195
Device Alarm System 185 185
Battery Problem 163 163
Inaudible or Unclear Audible Prompt/Feedback 162 162
Defective Alarm 155 155
Decreased Sensitivity 155 155
Failure to Transmit Record 105 105
Inappropriate or Unexpected Reset 101 101
Device Displays Incorrect Message 97 97
No Device Output 88 88
Premature Discharge of Battery 84 84
Defective Component 70 70
Overheating of Device 62 62
Device Difficult to Program or Calibrate 59 59
Output Problem 57 57
Data Problem 56 56
Defective Device 52 52
Incorrect Measurement 51 51
Insufficient Information 51 51
Audible Prompt/Feedback Problem 50 50
Patient Device Interaction Problem 46 46
Display or Visual Feedback Problem 43 43
Alarm Not Visible 40 40
Therapeutic or Diagnostic Output Failure 37 37
Melted 36 36
Low Audible Alarm 31 31
Use of Device Problem 30 30
Patient-Device Incompatibility 28 28
Biocompatibility 28 28
Protective Measures Problem 26 26
Device-Device Incompatibility 26 26
Excessive Heating 25 25
Incorrect, Inadequate or Imprecise Result or Readings 25 25
Break 25 25
Temperature Problem 24 24
Delayed Alarm 18 18
Smoking 17 17

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7257 7257
No Known Impact Or Consequence To Patient 3881 3881
No Consequences Or Impact To Patient 1193 1193
No Patient Involvement 676 676
Unspecified Infection 245 245
Insufficient Information 211 211
Erosion 176 176
Pain 171 171
Unspecified Heart Problem 101 101
Skin Inflammation/ Irritation 56 56
Cardiac Arrest 55 55
Erythema 47 47
Discomfort 44 44
Death 41 41
Hypersensitivity/Allergic reaction 37 37
Impaired Healing 31 31
Blister 27 27
Asystole 16 16
Arrhythmia 16 16
Itching Sensation 16 16
Purulent Discharge 16 16
Low Oxygen Saturation 16 16
Bradycardia 15 15
Hypoxia 14 14
Tachycardia 14 14
Superficial (First Degree) Burn 14 14
Burning Sensation 14 14
Rash 14 14
Hemorrhage/Bleeding 13 13
Skin Irritation 13 13
Swelling/ Edema 12 12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 12 12
No Code Available 10 10
Burn(s) 10 10
Bacterial Infection 10 10
Skin Tears 8 8
Ventricular Fibrillation 8 8
Bruise/Contusion 8 8
Electric Shock 7 7
Hematoma 7 7
Twiddlers Syndrome 7 7
Cardiopulmonary Arrest 7 7
Loss of consciousness 6 6
Diaphoresis 6 6
Chest Pain 6 6
Wound Dehiscence 6 6
Atrial Fibrillation 6 6
Cellulitis 6 6
Blood Loss 6 6
Dizziness 5 5

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