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
BIOMEDICAL SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 1
BRAEMAR MANUFACTURING, LLC
  SUBSTANTIALLY EQUIVALENT 1
CARD GUARD SCIENTIFIC SURVIVAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
CARD GUARD SCIENTIFIC SURVIVAL, LTD.
  SUBSTANTIALLY EQUIVALENT 2
CORCAM TECHNOLOGIA, SA
  SUBSTANTIALLY EQUIVALENT 1
CORVENTIS, INC.
  SUBSTANTIALLY EQUIVALENT 2
GLOBAL INSTRUMENTATION, LLC
  SUBSTANTIALLY EQUIVALENT 1
INFOBIONIC, INC.
  SUBSTANTIALLY EQUIVALENT 2
INTELESENS LIMITED
  SUBSTANTIALLY EQUIVALENT 1
INTRICON DATRIX CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
LIFEWATCH TECHNOLOGIES LTD
  SUBSTANTIALLY EQUIVALENT 1
LIFEWATCH TECHNOLOGIES LTD.
  SUBSTANTIALLY EQUIVALENT 3
MEDICAL.GORITHMICS S.A.
  SUBSTANTIALLY EQUIVALENT 1
MEDICALGORITHMICS S.A.
  SUBSTANTIALLY EQUIVALENT 4
MEDICALGORITHMICS SP Z.O.O.
  SUBSTANTIALLY EQUIVALENT 1
MEDICOMP, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEMTEC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
MENNEN MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 2
NATIONAL CARDIAC, INC.
  SUBSTANTIALLY EQUIVALENT 1
NIHON KOHDEN CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH
  SUBSTANTIALLY EQUIVALENT 2
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN
  SUBSTANTIALLY EQUIVALENT 2
PREVENTICE
  SUBSTANTIALLY EQUIVALENT 1
PREVENTICE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
PREVENTICE, INC.
  SUBSTANTIALLY EQUIVALENT 1
ROSS MEDICAL TECHNOLOGY, INC
  SUBSTANTIALLY EQUIVALENT 1
SCOTTCARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
SMARTCARDIA SA
  SUBSTANTIALLY EQUIVALENT 1
SPACELABS HEALTHCARE, INC.
  SUBSTANTIALLY EQUIVALENT 1
TZ MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
VITASYSTEMS GMBH
  SUBSTANTIALLY EQUIVALENT 1
WELCH ALLYN, INC.
  SUBSTANTIALLY EQUIVALENT 1
WPR MEDICAL AS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 999 999
2015 1639 1639
2016 4351 4351
2017 3594 3594
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 7248 7248
Over-Sensing 4743 4743
Premature Discharge of Battery 3373 3373
No Audible Alarm 3020 3020
Signal Artifact/Noise 1560 1560
Device Sensing Problem 1441 1441
No Audible Prompt/Feedback 1345 1345
Migration or Expulsion of Device 1211 1211
Adverse Event Without Identified Device or Use Problem 827 827
Device Operates Differently Than Expected 693 693
Communication or Transmission Problem 683 683
Unable to Obtain Readings 671 671
Failure to Interrogate 633 633
Reset Problem 590 590
Invalid Sensing 506 506
Device Alarm System 465 465
No Device Output 408 408
Electromagnetic Interference 405 405
Device Displays Incorrect Message 405 405
Appropriate Term/Code Not Available 362 362
Battery Problem 354 354
Decreased Sensitivity 322 322
Inaudible or Unclear Audible Prompt/Feedback 245 245
Inappropriate or Unexpected Reset 180 180
Incorrect Measurement 152 152
Defective Alarm 135 135
Failure to Transmit Record 107 107
Output Problem 99 99
Defective Device 98 98
Device Inoperable 97 97
Mechanical Problem 92 92
Break 78 78
Data Problem 77 77
Insufficient Information 76 76
Component Missing 74 74
Defective Component 73 73
Positioning Problem 63 63
Device Difficult to Program or Calibrate 62 62
False Positive Result 58 58
No Display/Image 56 56
Display or Visual Feedback Problem 51 51
Overheating of Device 50 50
Audible Prompt/Feedback Problem 48 48
Nonstandard Device 47 47
Patient Device Interaction Problem 46 46
Alarm Not Visible 43 43
Use of Device Problem 40 40
Therapeutic or Diagnostic Output Failure 37 37
Protective Measures Problem 34 34
Incorrect, Inadequate or Imprecise Result or Readings 33 33
Patient-Device Incompatibility 32 32
Computer Operating System Problem 31 31
Device-Device Incompatibility 31 31
Low Audible Alarm 30 30
Loss of Power 27 27
Failure to Power Up 27 27
Temperature Problem 25 25
Excessive Heating 25 25
Biocompatibility 22 22
Electrical /Electronic Property Problem 21 21
Noise, Audible 21 21
Melted 19 19
Smoking 18 18
Difficult to Remove 16 16
Human-Device Interface Problem 16 16
Computer Software Problem 16 16
Delayed Alarm 16 16
Failure to Sense 15 15
Detachment of Device or Device Component 14 14
Disconnection 14 14
Device Expiration Issue 13 13
Device Maintenance Issue 13 13
Improper or Incorrect Procedure or Method 13 13
Wireless Communication Problem 13 13
No Apparent Adverse Event 13 13
Device Fell 13 13
Connection Problem 12 12
Loss of Data 12 12
Battery Impedance Issue 11 11
Fire 10 10
Component Falling 10 10
Circuit Failure 10 10
Thermal Decomposition of Device 9 9
Application Interface Becomes Non-Functional Or Program Exits Abnormally 9 9
Loose or Intermittent Connection 9 9
Device Stops Intermittently 9 9
Inappropriate Audible Prompt/Feedback 8 8
Device Dislodged or Dislocated 8 8
Labelling, Instructions for Use or Training Problem 8 8
Operating System Becomes Nonfunctional 8 8
Material Integrity Problem 8 8
Mechanics Altered 8 8
Power Problem 7 7
Improper Device Output 7 7
Self-Activation or Keying 7 7
Product Quality Problem 7 7
Improper Flow or Infusion 6 6
Device Operational Issue 6 6
Pacing Problem 6 6
Manufacturing, Packaging or Shipping Problem 6 6

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 15395 15395
No Clinical Signs, Symptoms or Conditions 6500 6500
No Patient Involvement 1991 1991
No Consequences Or Impact To Patient 1579 1579
Unspecified Infection 429 429
Pain 365 365
Erosion 259 259
Insufficient Information 195 195
Death 134 134
Discomfort 113 113
No Code Available 111 111
Unspecified Heart Problem 101 101
Cardiac Arrest 73 73
Impaired Healing 72 72
Erythema 67 67
Hypersensitivity/Allergic reaction 54 54
Skin Irritation 46 46
Skin Inflammation/ Irritation 46 46
Bradycardia 30 30
Chest Pain 29 29
Swelling 29 29
Complaint, Ill-Defined 28 28
Low Oxygen Saturation 28 28
Purulent Discharge 28 28
Itching Sensation 27 27
Blister 26 26
No Information 25 25
Wound Dehiscence 23 23
Syncope 23 23
Burning Sensation 22 22
Dizziness 22 22
Arrhythmia 21 21
Rash 21 21
Ventricular Tachycardia 19 19
Blood Loss 19 19
Tachycardia 18 18
Twiddlers Syndrome 18 18
Hematoma 18 18
Hemorrhage/Bleeding 16 16
Hypoxia 16 16
Dyspnea 16 16
Burn(s) 15 15
Skin Erosion 14 14
Ventricular Fibrillation 13 13
Injury 13 13
Bruise/Contusion 13 13
Asystole 12 12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 11 11
Bacterial Infection 11 11
Cellulitis 11 11
Fall 11 11
Pocket Erosion 11 11
Loss of consciousness 11 11
Palpitations 10 10
Cardiopulmonary Arrest 10 10
Swelling/ Edema 10 10
Electric Shock 9 9
Skin Tears 8 8
Superficial (First Degree) Burn 8 8
Twiddlers Syndrome 7 7
Diaphoresis 7 7
Skin Discoloration 7 7
Atrial Fibrillation 7 7
Stroke/CVA 7 7
Seizures 7 7
Low Blood Pressure/ Hypotension 7 7
Shock 6 6
Skin Inflammation 6 6
Burn, Thermal 6 6
Discharge 5 5
Local Reaction 5 5
Irritation 5 5
Tissue Breakdown 5 5
Fluid Discharge 4 4
Unspecified Respiratory Problem 4 4
Skin Infection 4 4
Unspecified Tissue Injury 4 4
Endocarditis 4 4
Headache 4 4
Failure of Implant 4 4
Inflammation 4 4
Cyanosis 4 4
Fever 4 4
Pneumothorax 4 4
Caustic/Chemical Burns 4 4
Loss Of Pulse 4 4
Chest Tightness/Pressure 4 4
Sweating 3 3
Reaction 3 3
Sudden Cardiac Death 3 3
Tissue Damage 3 3
Tingling 3 3
Fatigue 3 3
Apnea 3 3
High Blood Pressure/ Hypertension 3 3
Perforation 3 3
Increased Sensitivity 3 3
Sepsis 3 3
Scar Tissue 3 3
Syncope/Fainting 3 3

Recalls
Manufacturer Recall Class Date Posted
1 Brentwood Medical Technology Corp II Jul-14-2011
2 GE Healthcare II Jan-05-2009
3 GE Healthcare, LLC II Dec-20-2019
4 GE Healthcare, LLC II Oct-23-2019
5 GE Medical Systems Information Tecnology II Sep-04-2009
6 GE Medical Systems Information Tecnology II May-04-2009
7 Medtronic Inc. II Mar-25-2016
8 Philips Electronics North America Corporation II Dec-10-2018
9 Philips Electronics North America Corporation II Jun-11-2018
10 Philips Electronics North America Corporation II Apr-04-2017
11 Philips Healthcare Inc. II Sep-29-2010
12 Philips Medical Systems II Jan-13-2009
13 Philips Medical Systems North America Co. Phillips II Oct-08-2010
14 Philips North America, LLC II Jul-10-2020
15 Philips North America, LLC II Jun-01-2019
16 Philips North America Llc II May-21-2021
17 Philips North America Llc II Dec-08-2020
18 Preventice Services, LLC II Jul-01-2020
19 Scottcare Corporation II Apr-01-2016
20 Scottcare Corporation II Apr-13-2012
21 Spacelabs Healthcare Inc II Aug-04-2016
22 Spacelabs Healthcare Inc II May-04-2015
23 Spacelabs Healthcare Inc II Apr-28-2015
24 Spacelabs Healthcare Inc II Jun-03-2014
25 Spacelabs Healthcare, Inc. II May-03-2023
26 Spacelabs Healthcare, Llc II Sep-14-2012
27 Spacelabs Healthcare, Llc II Jan-17-2012
28 Spacelabs Healthcare, Llc II Jan-11-2012
29 Welch Allyn Protocol, Inc II Aug-03-2011
30 Welch Allyn Protocol, Inc II Nov-12-2010
31 iRhythm Technologies, Inc. II Nov-04-2022
-
-