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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
2018 3647 3647
2019 3483 3483
2020 3084 3084
2021 3092 3092
2022 1638 1638
2023 1669 1669
2024 416 416

Device Problems MDRs with this Device Problem Events in those MDRs
Under-Sensing 5032 5032
Over-Sensing 3516 3516
No Audible Alarm 2272 2272
Signal Artifact/Noise 1470 1470
Device Sensing Problem 1318 1318
No Audible Prompt/Feedback 1157 1157
Adverse Event Without Identified Device or Use Problem 614 614
Communication or Transmission Problem 567 567
Migration or Expulsion of Device 563 563
Reset Problem 500 500
Unable to Obtain Readings 477 477
Electromagnetic Interference 400 400
Failure to Interrogate 339 339
Invalid Sensing 295 295
Decreased Sensitivity 264 264
Appropriate Term/Code Not Available 264 264
Battery Problem 256 256
Premature Discharge of Battery 221 221
No Device Output 202 202
Inaudible or Unclear Audible Prompt/Feedback 193 193
Device Alarm System 191 191
Device Displays Incorrect Message 182 182
Inappropriate or Unexpected Reset 138 138
Device Operates Differently Than Expected 120 120
Defective Alarm 118 118
Failure to Transmit Record 105 105
Incorrect Measurement 102 102
Defective Device 91 91
Output Problem 80 80
Defective Component 73 73
Data Problem 62 62
Device Difficult to Program or Calibrate 61 61
Insufficient Information 60 60
Display or Visual Feedback Problem 49 49
Audible Prompt/Feedback Problem 48 48
Patient Device Interaction Problem 46 46
Overheating of Device 45 45
Alarm Not Visible 41 41
Therapeutic or Diagnostic Output Failure 37 37
Break 34 34
Device Inoperable 31 31
Use of Device Problem 31 31
Incorrect, Inadequate or Imprecise Result or Readings 31 31
Patient-Device Incompatibility 30 30
Device-Device Incompatibility 28 28
Low Audible Alarm 28 28
Positioning Problem 26 26
Temperature Problem 25 25
Mechanical Problem 25 25
Excessive Heating 25 25
Protective Measures Problem 24 24
Biocompatibility 22 22
Nonstandard Device 22 22
Melted 19 19
Smoking 16 16
Delayed Alarm 16 16
Human-Device Interface Problem 16 16
Noise, Audible 16 16
No Display/Image 15 15
Electrical /Electronic Property Problem 14 14
Computer Software Problem 13 13
Detachment of Device or Device Component 13 13
Device Fell 13 13
No Apparent Adverse Event 13 13
Wireless Communication Problem 13 13
Failure to Sense 12 12
Computer Operating System Problem 10 10
Loss of Data 9 9
Difficult to Remove 9 9
Thermal Decomposition of Device 9 9
Disconnection 9 9
Fire 9 9
False Positive Result 8 8
Circuit Failure 8 8
Loss of Power 8 8
Inappropriate Audible Prompt/Feedback 8 8
Product Quality Problem 7 7
Improper or Incorrect Procedure or Method 7 7
Labelling, Instructions for Use or Training Problem 7 7
Improper Flow or Infusion 6 6
Naturally Worn 6 6
Sparking 5 5
Loose or Intermittent Connection 5 5
False Alarm 5 5
Device Difficult to Setup or Prepare 5 5
Unintended Electrical Shock 5 5
Intermittent Communication Failure 5 5
Unexpected Shutdown 4 4
Failure to Power Up 4 4
Telemetry Discrepancy 4 4
Image Display Error/Artifact 4 4
Device Expiration Issue 4 4
Application Program Problem 4 4
Low Readings 4 4
Inadequate Instructions for Non-Healthcare Professional 4 4
Device Dislodged or Dislocated 4 4
Connection Problem 4 4
Manufacturing, Packaging or Shipping Problem 4 4
Material Integrity Problem 4 4
Material Protrusion/Extrusion 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 7025 7025
No Clinical Signs, Symptoms or Conditions 6496 6496
No Consequences Or Impact To Patient 1235 1235
No Patient Involvement 873 873
Unspecified Infection 330 330
Pain 210 210
Erosion 204 204
Insufficient Information 195 195
Unspecified Heart Problem 101 101
Death 61 61
Erythema 57 57
Cardiac Arrest 53 53
Discomfort 50 50
Skin Inflammation/ Irritation 46 46
Impaired Healing 43 43
Hypersensitivity/Allergic reaction 41 41
Skin Irritation 30 30
Blister 26 26
No Code Available 25 25
Purulent Discharge 22 22
Itching Sensation 20 20
Low Oxygen Saturation 17 17
Bradycardia 16 16
Arrhythmia 16 16
Swelling 15 15
Burning Sensation 15 15
Rash 14 14
Hypoxia 14 14
Asystole 12 12
Bacterial Infection 11 11
Burn(s) 11 11
Chest Pain 11 11
Hemorrhage/Bleeding 11 11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 11 11
Swelling/ Edema 10 10
Dizziness 10 10
Skin Erosion 9 9
Blood Loss 9 9
Bruise/Contusion 9 9
Hematoma 8 8
Tachycardia 8 8
Electric Shock 8 8
Superficial (First Degree) Burn 8 8
Complaint, Ill-Defined 8 8
Injury 7 7
Ventricular Fibrillation 7 7
Loss of consciousness 7 7
Skin Tears 7 7
Cardiopulmonary Arrest 7 7
Wound Dehiscence 7 7
Twiddlers Syndrome 7 7
Cellulitis 6 6
Dyspnea 6 6
Skin Discoloration 6 6
Burn, Thermal 6 6
Diaphoresis 6 6
No Information 5 5
Local Reaction 5 5
Fall 5 5
Stroke/CVA 5 5
Atrial Fibrillation 5 5
Syncope 4 4
Seizures 4 4
Failure of Implant 4 4
Inflammation 4 4
Low Blood Pressure/ Hypotension 4 4
Pocket Erosion 4 4
Unspecified Respiratory Problem 4 4
Caustic/Chemical Burns 4 4
Palpitations 4 4
Skin Infection 4 4
Unspecified Tissue Injury 4 4
Skin Burning Sensation 3 3
Localized Skin Lesion 3 3
Contact Dermatitis 3 3
Sudden Cardiac Death 3 3
Skin Inflammation 3 3
Discharge 3 3
Syncope/Fainting 3 3
Fluid Discharge 3 3
Patient Problem/Medical Problem 3 3
Tissue Breakdown 3 3
Shock from Patient Lead(s) 3 3
Irritation 3 3
Fever 3 3
Headache 3 3
Cyanosis 3 3
Hair Loss 2 2
Fatigue 2 2
Apnea 2 2
Hypothermia 2 2
High Blood Pressure/ Hypertension 2 2
Myocardial Infarction 2 2
Increased Sensitivity 2 2
Shock 2 2
Scar Tissue 2 2
Scarring 2 2
Pneumothorax 2 2
Tissue Damage 2 2
Twiddlers Syndrome 2 2

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 North America, LLC II Jul-10-2020
6 Philips North America, LLC II Jun-01-2019
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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