Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 524 524

Device Problems MDRs with this Device Problem Events in those MDRs
Under-Sensing 5050 5050
Over-Sensing 3524 3524
No Audible Alarm 2306 2306
Signal Artifact/Noise 1472 1472
Device Sensing Problem 1319 1319
No Audible Prompt/Feedback 1170 1170
Adverse Event Without Identified Device or Use Problem 617 617
Communication or Transmission Problem 575 575
Migration or Expulsion of Device 567 567
Reset Problem 505 505
Unable to Obtain Readings 478 478
Electromagnetic Interference 400 400
Failure to Interrogate 340 340
Invalid Sensing 295 295
Appropriate Term/Code Not Available 267 267
Decreased Sensitivity 265 265
Battery Problem 257 257
Premature Discharge of Battery 221 221
No Device Output 202 202
Device Alarm System 196 196
Inaudible or Unclear Audible Prompt/Feedback 193 193
Device Displays Incorrect Message 182 182
Inappropriate or Unexpected Reset 138 138
Device Operates Differently Than Expected 120 120
Defective Alarm 119 119
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 49 49
Overheating of Device 47 47
Patient Device Interaction Problem 46 46
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
Protective Measures Problem 25 25
Temperature Problem 25 25
Mechanical Problem 25 25
Excessive Heating 25 25
Nonstandard Device 22 22
Biocompatibility 22 22
Melted 20 20
Noise, Audible 17 17
Smoking 16 16
Delayed Alarm 16 16
Human-Device Interface Problem 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
Disconnection 10 10
Computer Operating System Problem 10 10
Loss of Data 9 9
Fire 9 9
Thermal Decomposition of Device 9 9
Difficult to Remove 9 9
Loss of Power 8 8
False Positive Result 8 8
Circuit Failure 8 8
Inappropriate Audible Prompt/Feedback 8 8
Labelling, Instructions for Use or Training Problem 7 7
Product Quality Problem 7 7
Improper or Incorrect Procedure or Method 7 7
Improper Flow or Infusion 6 6
Naturally Worn 6 6
Unintended Electrical Shock 6 6
Intermittent Communication Failure 5 5
Sparking 5 5
Device Difficult to Setup or Prepare 5 5
Loose or Intermittent Connection 5 5
False Alarm 5 5
Device Expiration Issue 4 4
Failure to Power Up 4 4
Device Emits Odor 4 4
Telemetry Discrepancy 4 4
Image Display Error/Artifact 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 6597 6597
No Consequences Or Impact To Patient 1235 1235
No Patient Involvement 873 873
Unspecified Infection 331 331
Pain 212 212
Erosion 205 205
Insufficient Information 196 196
Unspecified Heart Problem 101 101
Death 61 61
Erythema 58 58
Cardiac Arrest 54 54
Discomfort 51 51
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 23 23
Itching Sensation 20 20
Low Oxygen Saturation 17 17
Burning Sensation 16 16
Bradycardia 16 16
Arrhythmia 16 16
Swelling 15 15
Rash 14 14
Hypoxia 14 14
Hemorrhage/Bleeding 12 12
Asystole 12 12
Chest Pain 11 11
Bacterial Infection 11 11
Burn(s) 11 11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 11 11
Swelling/ Edema 11 11
Dizziness 10 10
Skin Erosion 9 9
Superficial (First Degree) Burn 9 9
Blood Loss 9 9
Electric Shock 9 9
Bruise/Contusion 9 9
Hematoma 8 8
Tachycardia 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
Shock from Patient Lead(s) 4 4
Unspecified Respiratory Problem 4 4
Caustic/Chemical Burns 4 4
Palpitations 4 4
Unspecified Tissue Injury 4 4
Skin Infection 4 4
Syncope/Fainting 3 3
Skin Burning Sensation 3 3
Localized Skin Lesion 3 3
Contact Dermatitis 3 3
Respiratory Failure 3 3
Sudden Cardiac Death 3 3
Skin Inflammation 3 3
Discharge 3 3
Fluid Discharge 3 3
Patient Problem/Medical Problem 3 3
Tissue Breakdown 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
Perforation 2 2
Myocardial Infarction 2 2
Increased Sensitivity 2 2
Shock 2 2
Scar Tissue 2 2
Scarring 2 2
Pneumothorax 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
-
-