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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
Device computer, diagnostic, programmable
Product CodeDQK
Regulation Number 870.1425
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 5
ABBOTT ELECTROPHYSIOLOGY
  SUBSTANTIALLY EQUIVALENT 1
ABBOTT MEDICAL
  SUBSTANTIALLY EQUIVALENT 5
ABLACON, INC.
  SUBSTANTIALLY EQUIVALENT 1
ACUTUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 9
ALIVECOR, INC.
  SUBSTANTIALLY EQUIVALENT 3
BIOFOURMIS SINGAPORE PTE. LTD.
  SUBSTANTIALLY EQUIVALENT 1
BIOSENSE WEBSTER, INC.
  SUBSTANTIALLY EQUIVALENT 8
BIOSIG TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 7
CARDIOCALM SRL
  SUBSTANTIALLY EQUIVALENT 1
CARDIONXT, INC.
  SUBSTANTIALLY EQUIVALENT 1
CATHETER PRECISION, INC.
  SUBSTANTIALLY EQUIVALENT 2
CATHVISION APS
  SUBSTANTIALLY EQUIVALENT 1
CENTERLINE BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
CORDIANA MEDICAL INFORMATICS AG
  SUBSTANTIALLY EQUIVALENT 1
COROVENTIS RESEARCH AB
  SUBSTANTIALLY EQUIVALENT 1
EDWARDS LFESCIENCES
  SUBSTANTIALLY EQUIVALENT 1
EDWARDS LIFESCIENCES, LLC
  SUBSTANTIALLY EQUIVALENT 6
EDWARDS LIFESIENCES, LLC
  SUBSTANTIALLY EQUIVALENT 1
EPIPHANY HEALTHCARE, LLC
  SUBSTANTIALLY EQUIVALENT 1
GE HEALTHCARE INFORMATION TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG
  SUBSTANTIALLY EQUIVALENT 1
IMPLICITY, INC.
  SUBSTANTIALLY EQUIVALENT 1
IRHYTHM TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 4
MEDICALGORITHMICS S.A.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEM NEDERLAND B.V.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
  SUBSTANTIALLY EQUIVALENT 1
QUIPU S.R.L
  SUBSTANTIALLY EQUIVALENT 1
SCHWARZER CARDIOTEK GMBH
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN CAREWELL ELECTRONICS., LTD
  SUBSTANTIALLY EQUIVALENT 1
SPACELABS HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 1
ST. JUDE MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ST. JUDE MEDICAL (NOW ABBOTT MEDICAL)
  SUBSTANTIALLY EQUIVALENT 1
ST. JUDE MEDICAL (NOW PART OF THE ABBOTT MEDICAL)
  SUBSTANTIALLY EQUIVALENT 1
VEKTOR MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
VOLTA MEDICAL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 252 252
2018 261 261
2019 218 218
2020 215 215
2021 351 351
2022 215 215

Device Problems MDRs with this Device Problem Events in those MDRs
Communication or Transmission Problem 247 247
Display or Visual Feedback Problem 184 184
Incorrect Measurement 90 90
Image Orientation Incorrect 81 81
Incorrect, Inadequate or Imprecise Resultor Readings 70 70
Output Problem 62 62
Signal Artifact/Noise 55 55
No Display/Image 54 54
Failure to Power Up 47 47
Application Program Problem 44 44
Failure of Device to Self-Test 44 44
Adverse Event Without Identified Device or Use Problem 43 43
Device Issue 38 38
Computer Software Problem 38 38
Failure to Transmit Record 37 37
Data Problem 35 35
Device Displays Incorrect Message 34 34
Application Interface Becomes Non-Functional Or Program Exits Abnormally 34 34
Retraction Problem 31 31
Smoking 27 27
Appropriate Term/Code Not Available 27 27
Unexpected Shutdown 25 25
Pacing Problem 25 25
Use of Device Problem 24 24
Device Operates Differently Than Expected 21 21
Erratic or Intermittent Display 20 20
Sparking 18 18
Power Problem 18 18
Insufficient Information 17 17
Application Program Version or Upgrade Problem 16 16
Computer Operating System Problem 16 16
Noise, Audible 15 15
No Device Output 15 15
Patient Data Problem 14 14
Patient Device Interaction Problem 13 13
Application Program Freezes, Becomes Nonfunctional 13 13
Impedance Problem 13 13
Improper Device Output 13 13
Device Operational Issue 11 11
Failure to Analyze Signal 11 11
Poor Quality Image 11 11
Thermal Decomposition of Device 10 10
Connection Problem 9 9
Battery Problem 9 9
No Pacing 8 8
Material Twisted/Bent 8 8
Fire 8 8
Electromagnetic Interference 7 7
Electrical /Electronic Property Problem 7 7
Overheating of Device 7 7
Difficult to Remove 7 7
Intermittent Communication Failure 7 7
Material Integrity Problem 6 6
Operating System Version or Upgrade Problem 6 6
Device Emits Odor 6 6
Loose or Intermittent Connection 6 6
Mechanical Problem 5 5
Loss of Threshold 5 5
Loss of Power 5 5
Blocked Connection 5 5
Defective Device 5 5
Failure to Read Input Signal 4 4
Application Network Problem 4 4
No Apparent Adverse Event 4 4
Operating System Becomes Nonfunctional 4 4
Unintended Electrical Shock 4 4
Unintended Application Program Shut Down 4 4
Device Remains Activated 4 4
Self-Activation or Keying 3 3
Power Conditioning Problem 3 3
Improper or Incorrect Procedure or Method 3 3
Fitting Problem 3 3
Image Display Error/Artifact 3 3
Failure to Deliver Energy 3 3
Bent 3 3
Break 3 3
Device Alarm System 3 3
Material Deformation 3 3
Therapeutic or Diagnostic Output Failure 3 3
Environmental Compatibility Problem 3 3
Inadequate User Interface 3 3
Device Sensing Problem 3 3
Electrical Shorting 3 3
Detachment of Device or Device Component 3 3
High Readings 3 3
High Test Results 2 2
Arcing 2 2
Loss of Data 2 2
Activation, Positioning or SeparationProblem 2 2
Temperature Problem 2 2
No Fail-Safe Mechanism 2 2
No Visual Prompts/Feedback 2 2
Use of Incorrect Control Settings 2 2
Failure to Cycle 2 2
Melted 2 2
Fracture 2 2
High impedance 2 2
Failure to Zero 2 2
Device Inoperable 2 2
Inappropriate/Inadequate Shock/Stimulation 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 608 608
No Clinical Signs, Symptoms or Conditions 547 547
No Known Impact Or Consequence To Patient 256 256
Insufficient Information 27 27
No Patient Involvement 25 25
Cardiac Perforation 17 17
Death 13 13
Cardiac Arrest 7 7
Tissue Damage 7 7
Ventricular Fibrillation 6 6
Skin Tears 6 6
Cardiac Tamponade 5 5
Arrhythmia 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
No Information 5 5
Atrial Fibrillation 4 4
Burn(s) 3 3
Shock 3 3
Sudden Cardiac Death 3 3
Electric Shock 3 3
Complete Heart Block 3 3
Partial thickness (Second Degree) Burn 3 3
Heart Block 3 3
Reaction 2 2
Complaint, Ill-Defined 2 2
Ventricular Tachycardia 2 2
Rash 2 2
Low Blood Pressure/ Hypotension 2 2
Inflammation 2 2
Itching Sensation 1 1
Pain 1 1
Scarring 1 1
Sepsis 1 1
Tachycardia 1 1
Antibiotics, Reaction To 1 1
Bradycardia 1 1
Stroke/CVA 1 1
Hemorrhage/Bleeding 1 1
High Blood Pressure/ Hypertension 1 1
Cardiogenic Shock 1 1
Impaired Healing 1 1
Test Result 1 1
Patient Problem/Medical Problem 1 1
Syncope/Fainting 1 1
Asystole 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Laboratories Inc. (St Jude Medical) II Jun-14-2021
2 Biosense Webster (israel), Ltd. II Aug-24-2020
3 Boston Scientific Corporation II Apr-27-2020
4 CHANGE HEALTHCARE CANADA COMPANY II Apr-08-2020
5 CardioTek BV II Jun-23-2022
6 CardioTek BV II Jun-30-2017
7 Change Healthcare Israel Ltd. II May-24-2019
8 Edwards Lifesciences, LLC II May-08-2020
9 Edwards Lifesciences, LLC II Jan-16-2018
10 GE Healthcare Finland Oy II Oct-10-2018
11 GE Healthcare Finland Oy II Jul-02-2018
12 GE Healthcare, LLC II Apr-13-2022
13 GE Healthcare, LLC II Jun-22-2021
14 GE Healthcare, LLC II Oct-31-2019
15 GE Healthcare, LLC II Jul-23-2019
16 GE Medical Systems Information Technologies, Inc. II Jan-25-2018
17 Hitachi Healthcare Americas Corp Informatics Division II Sep-06-2018
18 Invivo Corporation II Nov-14-2018
19 McKesson Israel Ltd. II Aug-31-2018
20 Merge Healthcare, Inc. II Aug-28-2021
21 Merge Healthcare, Inc. II Jan-14-2018
22 Merge Healthcare, Inc. II Jul-10-2017
23 Merge Healthcare, Inc. II Jun-29-2017
24 Merge Healthcare, Inc. II May-02-2017
25 Merge Healthcare, Inc. II Apr-11-2017
26 Merge Healthcare, Inc. II Mar-14-2017
27 Merge Healthcare, Inc. II Feb-15-2017
28 Merge Healthcare, Inc. II Jan-24-2017
29 Philips Electronics North America Corporation II Dec-14-2018
30 Siemens Medical Solutions USA, Inc III Aug-18-2022
31 Siemens Medical Solutions USA, Inc II Jul-20-2022
32 Siemens Medical Solutions USA, Inc II Jun-06-2022
33 Siemens Medical Solutions USA, Inc II Jan-14-2022
34 Siemens Medical Solutions USA, Inc II Apr-19-2021
35 Siemens Medical Solutions USA, Inc II Mar-04-2021
36 Siemens Medical Solutions USA, Inc II Aug-28-2020
37 Siemens Medical Solutions USA, Inc II Feb-23-2019
38 Siemens Medical Solutions USA, Inc II Jul-06-2017
39 Siemens Medical Solutions USA, Inc II May-24-2017
40 Spacelabs Healthcare, Inc. II Jul-22-2019
41 Spacelabs Healthcare, Ltd. II Dec-10-2020
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