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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
MEDICALGORITHMICS S.A.
  SUBSTANTIALLY EQUIVALENT 2
MEDICOMP, INC.
  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
2017 3594 3594
2018 3647 3647
2019 3483 3483
2020 3084 3084
2021 3092 3092
2022 1638 1638
2023 1669 1669
2024 952 952

Device Problems MDRs with this Device Problem Events in those MDRs
Under-Sensing 6075 6075
Over-Sensing 4147 4147
No Audible Alarm 2798 2798
Signal Artifact/Noise 1491 1491
Device Sensing Problem 1361 1361
No Audible Prompt/Feedback 1215 1215
Premature Discharge of Battery 1030 1030
Migration or Expulsion of Device 750 750
Adverse Event Without Identified Device or Use Problem 699 699
Communication or Transmission Problem 644 644
Unable to Obtain Readings 567 567
Reset Problem 555 555
Invalid Sensing 467 467
Failure to Interrogate 414 414
Electromagnetic Interference 404 404
Decreased Sensitivity 321 321
Device Operates Differently Than Expected 298 298
Device Displays Incorrect Message 293 293
Appropriate Term/Code Not Available 291 291
Battery Problem 286 286
Device Alarm System 262 262
No Device Output 253 253
Inaudible or Unclear Audible Prompt/Feedback 218 218
Defective Alarm 154 154
Inappropriate or Unexpected Reset 151 151
Incorrect Measurement 117 117
Failure to Transmit Record 107 107
Defective Device 93 93
Output Problem 85 85
Defective Component 73 73
Mechanical Problem 69 69
Data Problem 66 66
Overheating of Device 62 62
Device Inoperable 62 62
Device Difficult to Program or Calibrate 62 62
Insufficient Information 61 61
Break 52 52
Display or Visual Feedback Problem 50 50
Audible Prompt/Feedback Problem 50 50
Patient Device Interaction Problem 46 46
Alarm Not Visible 43 43
Positioning Problem 38 38
Therapeutic or Diagnostic Output Failure 37 37
Melted 34 34
Use of Device Problem 33 33
Patient-Device Incompatibility 31 31
Low Audible Alarm 31 31
Incorrect, Inadequate or Imprecise Result or Readings 31 31
Device-Device Incompatibility 29 29
Protective Measures Problem 26 26

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 9952 9952
No Clinical Signs, Symptoms or Conditions 6984 6984
No Consequences Or Impact To Patient 1280 1280
No Patient Involvement 1274 1274
Unspecified Infection 375 375
Pain 266 266
Erosion 233 233
Insufficient Information 201 201
Unspecified Heart Problem 101 101
Death 83 83
Discomfort 66 66
Cardiac Arrest 65 65
Erythema 64 64
Impaired Healing 63 63
Skin Inflammation/ Irritation 54 54
Hypersensitivity/Allergic reaction 44 44
Skin Irritation 41 41
No Code Available 39 39
Purulent Discharge 29 29
Blister 27 27
Itching Sensation 23 23
Low Oxygen Saturation 23 23
Bradycardia 23 23
Swelling 21 21
Rash 18 18
Burning Sensation 18 18
Arrhythmia 18 18
Hypoxia 15 15
Asystole 14 14
Tachycardia 14 14
Chest Pain 14 14
Dizziness 14 14
Hemorrhage/Bleeding 14 14
Superficial (First Degree) Burn 14 14
Burn(s) 13 13
Blood Loss 13 13
Dyspnea 12 12
Bacterial Infection 12 12
Skin Erosion 12 12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 12 12
Swelling/ Edema 11 11
Bruise/Contusion 11 11
Cardiopulmonary Arrest 10 10
Electric Shock 10 10
No Information 10 10
Hematoma 10 10
Loss of consciousness 10 10
Complaint, Ill-Defined 9 9
Skin Tears 9 9
Injury 9 9

Recalls
Manufacturer Recall Class Date Posted
1 GE Healthcare, LLC II Dec-20-2019
2 GE Healthcare, LLC II Oct-23-2019
3 Philips Electronics North America Corporation II Dec-10-2018
4 Philips Electronics North America Corporation II Jun-11-2018
5 Philips Electronics North America Corporation II Apr-04-2017
6 Philips North America, LLC II Jul-10-2020
7 Philips North America, LLC II Jun-01-2019
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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