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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 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 524 524

Device Problems MDRs with this Device Problem Events in those MDRs
Under-Sensing 3788 3788
Over-Sensing 2654 2654
No Audible Alarm 2054 2054
No Audible Prompt/Feedback 1149 1149
Signal Artifact/Noise 1115 1115
Device Sensing Problem 1079 1079
Communication or Transmission Problem 514 514
Adverse Event Without Identified Device or Use Problem 485 485
Reset Problem 449 449
Migration or Expulsion of Device 381 381
Electromagnetic Interference 377 377
Unable to Obtain Readings 364 364
Failure to Interrogate 263 263
Appropriate Term/Code Not Available 186 186
Device Alarm System 170 170
Inaudible or Unclear Audible Prompt/Feedback 162 162
Decreased Sensitivity 155 155
Battery Problem 148 148
Defective Alarm 113 113
Failure to Transmit Record 104 104
Inappropriate or Unexpected Reset 100 100
Device Displays Incorrect Message 97 97
No Device Output 86 86
Premature Discharge of Battery 82 82
Defective Component 70 70
Device Difficult to Program or Calibrate 59 59
Data Problem 54 54
Defective Device 52 52
Output Problem 51 51
Insufficient Information 51 51
Incorrect Measurement 49 49
Audible Prompt/Feedback Problem 48 48
Patient Device Interaction Problem 46 46
Overheating of Device 44 44
Display or Visual Feedback Problem 41 41
Alarm Not Visible 39 39
Therapeutic or Diagnostic Output Failure 37 37
Use of Device Problem 30 30
Low Audible Alarm 28 28
Patient-Device Incompatibility 28 28
Device-Device Incompatibility 26 26
Protective Measures Problem 25 25
Break 25 25
Excessive Heating 25 25
Temperature Problem 24 24
Biocompatibility 22 22
Incorrect, Inadequate or Imprecise Result or Readings 22 22
Melted 20 20
Smoking 16 16
Delayed Alarm 16 16
Human-Device Interface Problem 16 16
Positioning Problem 14 14
Electrical /Electronic Property Problem 14 14
Computer Software Problem 13 13
Wireless Communication Problem 13 13
No Display/Image 12 12
Mechanical Problem 12 12
No Apparent Adverse Event 12 12
Detachment of Device or Device Component 12 12
Device Fell 11 11
Failure to Sense 11 11
Fire 9 9
Thermal Decomposition of Device 9 9
Noise, Audible 9 9
Computer Operating System Problem 8 8
Disconnection 8 8
Inappropriate Audible Prompt/Feedback 8 8
Product Quality Problem 7 7
Labelling, Instructions for Use or Training Problem 7 7
Circuit Failure 7 7
Difficult to Remove 6 6
Improper Flow or Infusion 6 6
Loss of Data 6 6
Unintended Electrical Shock 6 6
Naturally Worn 6 6
Intermittent Communication Failure 5 5
Sparking 5 5
Device Difficult to Setup or Prepare 5 5
Improper or Incorrect Procedure or Method 5 5
False Alarm 5 5
False Positive Result 4 4
Loose or Intermittent Connection 4 4
Low Readings 4 4
Loss of Power 4 4
Connection Problem 4 4
Material Integrity Problem 4 4
Inadequate Instructions for Non-Healthcare Professional 4 4
Unexpected Shutdown 4 4
Packaging Problem 4 4
Patient Data Problem 4 4
Device Handling Problem 3 3
Missing Test Results 3 3
Power Problem 3 3
Complete Loss of Power 3 3
Device Dislodged or Dislocated 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Application Program Problem 3 3
Pacing Problem 3 3
Device Emits Odor 3 3
Failure to Charge 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6596 6596
No Known Impact Or Consequence To Patient 3881 3881
No Consequences Or Impact To Patient 1193 1193
No Patient Involvement 676 676
Unspecified Infection 231 231
Insufficient Information 196 196
Erosion 171 171
Pain 162 162
Unspecified Heart Problem 101 101
Cardiac Arrest 50 50
Skin Inflammation/ Irritation 46 46
Erythema 45 45
Death 41 41
Discomfort 41 41
Hypersensitivity/Allergic reaction 36 36
Impaired Healing 31 31
Blister 26 26
Arrhythmia 16 16
Purulent Discharge 15 15
Itching Sensation 15 15
Low Oxygen Saturation 15 15
Hypoxia 14 14
Bradycardia 14 14
Rash 13 13
Burning Sensation 13 13
Skin Irritation 13 13
Hemorrhage/Bleeding 12 12
Asystole 12 12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 11 11
Swelling/ Edema 11 11
No Code Available 10 10
Burn(s) 10 10
Bacterial Infection 9 9
Superficial (First Degree) Burn 9 9
Bruise/Contusion 8 8
Tachycardia 8 8
Ventricular Fibrillation 7 7
Cardiopulmonary Arrest 7 7
Hematoma 7 7
Skin Tears 7 7
Twiddlers Syndrome 7 7
Electric Shock 6 6
Blood Loss 6 6
Diaphoresis 6 6
Loss of consciousness 6 6
Cellulitis 6 6
Chest Pain 6 6
Atrial Fibrillation 5 5
Wound Dehiscence 5 5
Swelling 5 5
Dizziness 5 5
Local Reaction 5 5
Skin Erosion 5 5
Caustic/Chemical Burns 4 4
Skin Infection 4 4
Unspecified Tissue Injury 4 4
Unspecified Respiratory Problem 4 4
Pocket Erosion 4 4
Failure of Implant 4 4
Stroke/CVA 4 4
Fall 4 4
Headache 3 3
Fever 3 3
Low Blood Pressure/ Hypotension 3 3
Inflammation 3 3
Skin Discoloration 3 3
Skin Burning Sensation 3 3
Localized Skin Lesion 3 3
Shock from Patient Lead(s) 3 3
Sudden Cardiac Death 3 3
Syncope/Fainting 3 3
Contact Dermatitis 3 3
Burn, Thermal 3 3
Fluid Discharge 3 3
Patient Problem/Medical Problem 3 3
Respiratory Failure 3 3
Skin Inflammation 3 3
Complaint, Ill-Defined 3 3
Injury 3 3
Irritability 2 2
Irregular Pulse 2 2
Tissue Breakdown 2 2
Partial thickness (Second Degree) Burn 2 2
No Information 2 2
Respiratory Arrest 2 2
Pneumothorax 2 2
Rupture 2 2
Hypothermia 2 2
Perforation 2 2
Scar Tissue 2 2
Increased Sensitivity 2 2
Shock 2 2
Hair Loss 2 2
High Blood Pressure/ Hypertension 2 2
Dyspnea 2 2
Cyanosis 2 2
Apnea 2 2
Abscess 1 1
Anaphylactic Shock 1 1
Autoimmune Reaction 1 1

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 Llc II May-21-2021
6 Philips North America Llc II Dec-08-2020
7 Preventice Services, LLC II Jul-01-2020
8 Spacelabs Healthcare, Inc. II May-03-2023
9 iRhythm Technologies, Inc. II Nov-04-2022
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