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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 756 756

Device Problems MDRs with this Device Problem Events in those MDRs
Under-Sensing 3818 3818
Over-Sensing 2679 2679
No Audible Alarm 2131 2131
No Audible Prompt/Feedback 1173 1173
Signal Artifact/Noise 1126 1126
Device Sensing Problem 1089 1089
Communication or Transmission Problem 540 540
Adverse Event Without Identified Device or Use Problem 496 496
Reset Problem 458 458
Electromagnetic Interference 381 381
Migration or Expulsion of Device 381 381
Unable to Obtain Readings 370 370
Failure to Interrogate 263 263
Appropriate Term/Code Not Available 186 186
Device Alarm System 175 175
Inaudible or Unclear Audible Prompt/Feedback 162 162
Decreased Sensitivity 155 155
Battery Problem 152 152
Defective Alarm 125 125
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 83 83
Defective Component 70 70
Device Difficult to Program or Calibrate 59 59
Data Problem 54 54
Output Problem 52 52
Defective Device 52 52
Insufficient Information 51 51
Overheating of Device 51 51
Incorrect Measurement 50 50
Audible Prompt/Feedback Problem 48 48
Patient Device Interaction Problem 46 46
Display or Visual Feedback Problem 42 42
Alarm Not Visible 39 39
Therapeutic or Diagnostic Output Failure 37 37
Low Audible Alarm 30 30
Use of Device Problem 30 30
Patient-Device Incompatibility 28 28
Biocompatibility 26 26
Device-Device Incompatibility 26 26
Protective Measures Problem 26 26
Break 25 25
Excessive Heating 25 25
Melted 24 24
Temperature Problem 24 24
Incorrect, Inadequate or Imprecise Result or Readings 22 22
Delayed Alarm 17 17
Smoking 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
Fire 11 11
Failure to Sense 11 11
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
False Alarm 6 6
Difficult to Remove 6 6
Sparking 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
Device Difficult to Setup or Prepare 5 5
Improper or Incorrect Procedure or Method 5 5
Low Readings 4 4
Loss of Power 4 4
Device Emits Odor 4 4
False Positive Result 4 4
Loose or Intermittent Connection 4 4
Unexpected Shutdown 4 4
Packaging Problem 4 4
Patient Data Problem 4 4
Material Integrity Problem 4 4
Inadequate Instructions for Non-Healthcare Professional 4 4
Connection Problem 4 4
Application Program Problem 3 3
Device Dislodged or Dislocated 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Device Handling Problem 3 3
Missing Test Results 3 3
Power Problem 3 3
Complete Loss of Power 3 3
Failure to Charge 3 3
Use of Incorrect Control/Treatment Settings 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6804 6804
No Known Impact Or Consequence To Patient 3881 3881
No Consequences Or Impact To Patient 1193 1193
No Patient Involvement 676 676
Unspecified Infection 238 238
Insufficient Information 199 199
Erosion 172 172
Pain 162 162
Unspecified Heart Problem 101 101
Cardiac Arrest 53 53
Skin Inflammation/ Irritation 52 52
Erythema 45 45
Death 41 41
Discomfort 41 41
Hypersensitivity/Allergic reaction 36 36
Impaired Healing 31 31
Blister 27 27
Itching Sensation 16 16
Arrhythmia 16 16
Purulent Discharge 15 15
Low Oxygen Saturation 15 15
Bradycardia 14 14
Hypoxia 14 14
Rash 13 13
Skin Irritation 13 13
Burning Sensation 13 13
Hemorrhage/Bleeding 13 13
Asystole 12 12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 11 11
Swelling/ Edema 11 11
No Code Available 10 10
Superficial (First Degree) Burn 10 10
Burn(s) 10 10
Tachycardia 10 10
Bacterial Infection 9 9
Bruise/Contusion 8 8
Skin Tears 8 8
Twiddlers Syndrome 7 7
Cardiopulmonary Arrest 7 7
Hematoma 7 7
Ventricular Fibrillation 7 7
Chest Pain 6 6
Cellulitis 6 6
Electric Shock 6 6
Blood Loss 6 6
Loss of consciousness 6 6
Diaphoresis 6 6
Skin Erosion 5 5
Atrial Fibrillation 5 5
Wound Dehiscence 5 5
Dizziness 5 5
Swelling 5 5
Local Reaction 5 5
Failure of Implant 4 4
Pocket Erosion 4 4
Stroke/CVA 4 4
Fall 4 4
Caustic/Chemical Burns 4 4
Skin Infection 4 4
Unspecified Tissue Injury 4 4
Skin Burning Sensation 4 4
Unspecified Respiratory Problem 4 4
Localized Skin Lesion 3 3
Contact Dermatitis 3 3
Syncope/Fainting 3 3
Shock from Patient Lead(s) 3 3
Sudden Cardiac Death 3 3
Fluid Discharge 3 3
Patient Problem/Medical Problem 3 3
Respiratory Failure 3 3
Burn, Thermal 3 3
Skin Inflammation 3 3
Complaint, Ill-Defined 3 3
Injury 3 3
Fever 3 3
Headache 3 3
Inflammation 3 3
Low Blood Pressure/ Hypotension 3 3
Skin Discoloration 3 3
Pneumothorax 2 2
Scar Tissue 2 2
Increased Sensitivity 2 2
Shock 2 2
Hypothermia 2 2
High Blood Pressure/ Hypertension 2 2
Perforation 2 2
Hair Loss 2 2
Cyanosis 2 2
Dyspnea 2 2
Apnea 2 2
Rupture 2 2
Irritability 2 2
Irregular Pulse 2 2
Tissue Breakdown 2 2
No Information 2 2
Partial thickness (Second Degree) Burn 2 2
Respiratory Arrest 2 2
Respiratory Insufficiency 1 1
Bronchial Hemorrhage 1 1
Cancer 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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