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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 MEDICAL
  SUBSTANTIALLY EQUIVALENT 6
ABLACON, INC.
  SUBSTANTIALLY EQUIVALENT 1
ACUTUS MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
ACUTUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 8
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 6
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 LIFECIENCES, LLC
  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
IMPLICITY, INC.
  SUBSTANTIALLY EQUIVALENT 1
IRHYTHM TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 5
ITAMAR MEDICAL, LTD.
  SUBSTANTIALLY EQUIVALENT 1
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
PHILIPS MEDICAL SYSTEMS NEDERLAND, B.V. (PMSN)
  SUBSTANTIALLY EQUIVALENT 1
QUIPU S.R.L
  SUBSTANTIALLY EQUIVALENT 1
RHYTHM AL, LTD
  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
VEKTOR MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
VOLTA MEDICAL
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2018 261 261
2019 218 218
2020 215 215
2021 351 351
2022 319 319
2023 58 58

Device Problems MDRs with this Device Problem Events in those MDRs
Communication or Transmission Problem 265 265
Display or Visual Feedback Problem 213 213
Incorrect Measurement 88 88
Image Orientation Incorrect 81 81
Incorrect, Inadequate or Imprecise Result or Readings 73 73
Output Problem 73 73
Signal Artifact/Noise 64 64
Application Program Problem 46 46
Failure of Device to Self-Test 46 46
Failure to Power Up 44 44
No Display/Image 43 43
Adverse Event Without Identified Device or Use Problem 35 35
Computer Software Problem 32 32
Retraction Problem 31 31
Unexpected Shutdown 30 30
Smoking 29 29
Appropriate Term/Code Not Available 27 27
Use of Device Problem 25 25
Pacing Problem 24 24
Device Displays Incorrect Message 22 22
Patient Device Interaction Problem 21 21
Erratic or Intermittent Display 21 21
Sparking 19 19
Computer Operating System Problem 17 17
Patient Data Problem 14 14
Application Program Version or Upgrade Problem 14 14
No Device Output 13 13
Application Program Freezes, Becomes Nonfunctional 13 13
Impedance Problem 13 13
Poor Quality Image 12 12
Failure to Analyze Signal 11 11
Power Problem 11 11
Data Problem 11 11
Noise, Audible 11 11
Fire 10 10
Thermal Decomposition of Device 10 10
Electromagnetic Interference 9 9
Material Twisted/Bent 9 9
Insufficient Information 9 9
No Pacing 8 8
Electrical /Electronic Property Problem 8 8
Loose or Intermittent Connection 8 8
Failure to Transmit Record 7 7
Intermittent Communication Failure 7 7
Improper Device Output 7 7
Material Integrity Problem 7 7
Connection Problem 7 7
Device Operational Issue 6 6
Operating System Version or Upgrade Problem 6 6
Device Issue 6 6
Defective Device 6 6
Device Emits Odor 6 6
Mechanical Problem 6 6
Loss of Threshold 5 5
Loss of Power 5 5
Device Remains Activated 4 4
Overheating of Device 4 4
Operating System Becomes Nonfunctional 4 4
Device Operates Differently Than Expected 4 4
Electrical Shorting 4 4
Unintended Application Program Shut Down 4 4
Unintended Electrical Shock 4 4
Environmental Compatibility Problem 3 3
Detachment of Device or Device Component 3 3
Material Deformation 3 3
Inadequate User Interface 3 3
Therapeutic or Diagnostic Output Failure 3 3
Failure to Deliver Energy 3 3
Application Interface Becomes Non-Functional Or Program Exits Abnormally 3 3
Break 3 3
Failure to Read Input Signal 3 3
Power Conditioning Problem 3 3
Improper or Incorrect Procedure or Method 3 3
Fitting Problem 3 3
High Test Results 2 2
High Readings 2 2
Low Readings 2 2
Failure to Disconnect 2 2
Arcing 2 2
Battery Problem 2 2
Inappropriate/Inadequate Shock/Stimulation 2 2
Self-Activation or Keying 2 2
Use of Incorrect Control/Treatment Settings 2 2
Melted 2 2
Unintended System Motion 2 2
Fracture 2 2
High impedance 2 2
No Apparent Adverse Event 2 2
Temperature Problem 2 2
Application Network Problem 2 2
Activation, Positioning or Separation Problem 2 2
Device Sensing Problem 2 2
No Visual Prompts/Feedback 2 2
Tactile Prompts/Feedback 1 1
No Tactile Prompts/Feedback 1 1
Radiation Output Problem 1 1
Radiation Output Failure 1 1
Fail-Safe Did Not Operate 1 1
Intermittent Loss of Power 1 1
Device Handling Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 695 695
No Consequences Or Impact To Patient 522 522
No Known Impact Or Consequence To Patient 126 126
Insufficient Information 31 31
Cardiac Perforation 18 18
No Patient Involvement 16 16
Death 9 9
Skin Tears 7 7
Arrhythmia 6 6
Cardiac Arrest 6 6
No Information 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Shock 4 4
Cardiac Tamponade 3 3
Stroke/CVA 3 3
Atrial Fibrillation 3 3
Heart Block 3 3
Electric Shock 3 3
Ventricular Fibrillation 3 3
Partial thickness (Second Degree) Burn 2 2
Complete Heart Block 2 2
Complaint, Ill-Defined 2 2
Reaction 2 2
Sudden Cardiac Death 2 2
Rash 2 2
Anaphylactic Shock 1 1
Tachycardia 1 1
Burn(s) 1 1
Hemorrhage/Bleeding 1 1
High Blood Pressure/ Hypertension 1 1
Low Blood Pressure/ Hypotension 1 1
Itching Sensation 1 1
Test Result 1 1
Ventricular Tachycardia 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 Change Healthcare Israel Ltd. II May-24-2019
7 Edwards Lifesciences, LLC II May-08-2020
8 Edwards Lifesciences, LLC II Jan-16-2018
9 GE Healthcare Finland Oy II Oct-10-2018
10 GE Healthcare Finland Oy II Jul-02-2018
11 GE Healthcare, LLC II Apr-13-2022
12 GE Healthcare, LLC II Jun-22-2021
13 GE Healthcare, LLC II Oct-31-2019
14 GE Healthcare, LLC II Jul-23-2019
15 GE Medical Systems Information Technologies, Inc. II Jan-25-2018
16 Hitachi Healthcare Americas Corp Informatics Division II Sep-06-2018
17 Invivo Corporation II Nov-14-2018
18 McKesson Israel Ltd. II Aug-31-2018
19 Merge Healthcare, Inc. II Aug-28-2021
20 Merge Healthcare, Inc. II Jan-14-2018
21 Philips Electronics North America Corporation II Dec-14-2018
22 Siemens Medical Solutions USA, Inc II Jan-01-2023
23 Siemens Medical Solutions USA, Inc III Aug-18-2022
24 Siemens Medical Solutions USA, Inc II Jul-20-2022
25 Siemens Medical Solutions USA, Inc II Jun-06-2022
26 Siemens Medical Solutions USA, Inc II Jan-14-2022
27 Siemens Medical Solutions USA, Inc II Apr-19-2021
28 Siemens Medical Solutions USA, Inc II Mar-04-2021
29 Siemens Medical Solutions USA, Inc II Aug-28-2020
30 Siemens Medical Solutions USA, Inc II Feb-23-2019
31 Spacelabs Healthcare, Inc. II Jul-22-2019
32 Spacelabs Healthcare, Ltd. II Dec-10-2020
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