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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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 7
ABLACON, INC.
  SUBSTANTIALLY EQUIVALENT 2
ACUTUS MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 1
ACUTUS MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
ACUTUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 10
ALIVECOR, INC.
  SUBSTANTIALLY EQUIVALENT 3
ANUMANA, INC
  SUBSTANTIALLY EQUIVALENT 1
BIOFOURMIS SINGAPORE PTE. LTD.
  SUBSTANTIALLY EQUIVALENT 1
BIOSENSE WEBSTER, INC.
  SUBSTANTIALLY EQUIVALENT 10
BIOSIG TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 8
CARDIOCALM SRL
  SUBSTANTIALLY EQUIVALENT 1
CARDIONXT, INC.
  SUBSTANTIALLY EQUIVALENT 1
CATH VISION APS
  SUBSTANTIALLY EQUIVALENT 1
CATHETER PRECISION, INC.
  SUBSTANTIALLY EQUIVALENT 2
CATHVISION APS
  SUBSTANTIALLY EQUIVALENT 1
CENTERLINE BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
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 1
EDWARDS LIFESCIENCES, LLC
  SUBSTANTIALLY EQUIVALENT 10
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 2
GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG
  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 2
PHILIPS MEDICAL SYSTEM NEDERLAND B.V.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
  SUBSTANTIALLY EQUIVALENT 3
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
SIEMENS MEDICAL SOLUTIONS USA INC.
  SUBSTANTIALLY EQUIVALENT 1
SMART SOLUTIONS TECHNOLOGIES SL
  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 3

MDR Year MDR Reports MDR Events
2017 252 252
2018 261 261
2019 218 218
2020 215 215
2021 351 351
2022 319 319
2023 368 368
2024 138 138

Device Problems MDRs with this Device Problem Events in those MDRs
Communication or Transmission Problem 381 381
Display or Visual Feedback Problem 287 287
Failure to Transmit Record 127 127
Incorrect Measurement 123 123
Signal Artifact/Noise 103 103
Incorrect, Inadequate or Imprecise Result or Readings 92 92
Output Problem 87 87
Image Orientation Incorrect 81 81
Failure of Device to Self-Test 64 64
No Display/Image 57 57
Failure to Power Up 54 54
Application Program Problem 53 53
Adverse Event Without Identified Device or Use Problem 48 48
Pacing Problem 44 44
Computer Software Problem 44 44
Device Issue 38 38
Device Displays Incorrect Message 36 36
Data Problem 35 35
Application Interface Becomes Non-Functional Or Program Exits Abnormally 34 34
Smoking 34 34
Unexpected Shutdown 34 34
Retraction Problem 31 31
Appropriate Term/Code Not Available 30 30
Use of Device Problem 29 29
Erratic or Intermittent Display 27 27
Power Problem 24 24
Patient Device Interaction Problem 23 23
Computer Operating System Problem 23 23
Device Operates Differently Than Expected 21 21
Sparking 20 20
Insufficient Information 19 19
Impedance Problem 19 19
Poor Quality Image 18 18
Electromagnetic Interference 17 17
Electrical /Electronic Property Problem 17 17
No Device Output 17 17
Application Program Version or Upgrade Problem 17 17
Noise, Audible 15 15
Device Emits Odor 15 15
Inaccurate Information 15 15
Thermal Decomposition of Device 14 14
Patient Data Problem 14 14
Improper Device Output 13 13
Material Integrity Problem 13 13
Material Twisted/Bent 13 13
Application Program Freezes, Becomes Nonfunctional 13 13
Connection Problem 12 12
Loose or Intermittent Connection 12 12
Overheating of Device 11 11
Failure to Analyze Signal 11 11
Fire 11 11
Device Operational Issue 11 11
Defective Device 11 11
No Pacing 11 11
Battery Problem 9 9
Electrical Shorting 8 8
Mechanical Problem 7 7
Difficult to Remove 7 7
Intermittent Communication Failure 7 7
Fitting Problem 6 6
Operating System Version or Upgrade Problem 6 6
No Apparent Adverse Event 5 5
Blocked Connection 5 5
Loss of Power 5 5
Loss of Threshold 5 5
Failure to Read Input Signal 4 4
Device Remains Activated 4 4
Power Conditioning Problem 4 4
Image Display Error/Artifact 4 4
Activation, Positioning or Separation Problem 4 4
Device Sensing Problem 4 4
Application Network Problem 4 4
Unintended Electrical Shock 4 4
Operating System Becomes Nonfunctional 4 4
Unintended Application Program Shut Down 4 4
No Visual Prompts/Feedback 4 4
Inadequate User Interface 3 3
Failure to Auto Stop 3 3
Environmental Compatibility Problem 3 3
Material Deformation 3 3
Therapeutic or Diagnostic Output Failure 3 3
Detachment of Device or Device Component 3 3
High Readings 3 3
Low Readings 3 3
Device Alarm System 3 3
High impedance 3 3
Bent 3 3
Break 3 3
Failure to Deliver Energy 3 3
Improper or Incorrect Procedure or Method 3 3
Self-Activation or Keying 3 3
Failure to Zero 2 2
Inappropriate/Inadequate Shock/Stimulation 2 2
Device Inoperable 2 2
Over-Sensing 2 2
Product Quality Problem 2 2
Failure to Cycle 2 2
Use of Incorrect Control/Treatment Settings 2 2
Fracture 2 2
Leak/Splash 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1030 1030
No Consequences Or Impact To Patient 608 608
No Known Impact Or Consequence To Patient 256 256
Unspecified Heart Problem 98 98
Insufficient Information 34 34
No Patient Involvement 25 25
Cardiac Perforation 23 23
Death 13 13
Arrhythmia 10 10
Cardiac Arrest 9 9
Skin Tears 8 8
Tissue Damage 7 7
Atrial Fibrillation 7 7
Ventricular Fibrillation 6 6
Cardiac Tamponade 5 5
No Information 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Shock 4 4
Electric Shock 3 3
Stroke/CVA 3 3
Low Blood Pressure/ Hypotension 3 3
Complete Heart Block 3 3
Heart Block 3 3
Partial thickness (Second Degree) Burn 3 3
Burn(s) 3 3
Sudden Cardiac Death 3 3
Pericardial Effusion 2 2
Asystole 2 2
Inflammation 2 2
Complaint, Ill-Defined 2 2
Reaction 2 2
Rash 2 2
Ventricular Tachycardia 2 2
Cardiogenic Shock 1 1
Scarring 1 1
Sepsis 1 1
Tachycardia 1 1
Needle Stick/Puncture 1 1
Impaired Healing 1 1
Diminished Pulse Pressure 1 1
Itching Sensation 1 1
Nerve Damage 1 1
Pain 1 1
Perforation 1 1
Failure of Implant 1 1
Hemorrhage/Bleeding 1 1
High Blood Pressure/ Hypertension 1 1
Anaphylactic Shock 1 1
Antibiotics, Reaction To 1 1
Atrial Flutter 1 1
Bradycardia 1 1
Syncope/Fainting 1 1
Test Result 1 1
Patient Problem/Medical Problem 1 1

Recalls
Manufacturer Recall Class Date Posted
1 APN Health LLC III Dec-14-2023
2 Abbott Laboratories Inc. (St Jude Medical) II Jun-14-2021
3 Baxter Healthcare Corporation II Sep-28-2023
4 Biosense Webster (israel), Ltd. II Aug-24-2020
5 Boston Scientific Corporation II Apr-27-2020
6 CHANGE HEALTHCARE CANADA COMPANY II Apr-08-2020
7 CardioTek BV II Jun-23-2022
8 CardioTek BV II Jun-30-2017
9 Change Healthcare Israel Ltd. II May-24-2019
10 Edwards Lifesciences, LLC II May-08-2020
11 Edwards Lifesciences, LLC II Jan-16-2018
12 GE Healthcare Finland Oy II Oct-10-2018
13 GE Healthcare Finland Oy II Jul-02-2018
14 GE Healthcare, LLC II Apr-13-2022
15 GE Healthcare, LLC II Jun-22-2021
16 GE Healthcare, LLC II Oct-31-2019
17 GE Healthcare, LLC II Jul-23-2019
18 GE Medical Systems Information Technologies Inc II Sep-19-2023
19 GE Medical Systems Information Technologies, Inc. II Jan-25-2018
20 Hitachi Healthcare Americas Corp Informatics Division II Sep-06-2018
21 Invivo Corporation II Nov-14-2018
22 McKesson Israel Ltd. II Aug-31-2018
23 Merge Healthcare, Inc. II Aug-28-2021
24 Merge Healthcare, Inc. II Jan-14-2018
25 Merge Healthcare, Inc. II Jul-10-2017
26 Merge Healthcare, Inc. II Jun-29-2017
27 Merge Healthcare, Inc. II May-02-2017
28 Merge Healthcare, Inc. II Apr-11-2017
29 Merge Healthcare, Inc. II Mar-14-2017
30 Merge Healthcare, Inc. II Feb-15-2017
31 Merge Healthcare, Inc. II Jan-24-2017
32 Philips Electronics North America Corporation II Dec-14-2018
33 Siemens Medical Solutions USA, Inc II Jan-09-2024
34 Siemens Medical Solutions USA, Inc II Jan-01-2023
35 Siemens Medical Solutions USA, Inc III Aug-18-2022
36 Siemens Medical Solutions USA, Inc II Jul-20-2022
37 Siemens Medical Solutions USA, Inc II Jun-06-2022
38 Siemens Medical Solutions USA, Inc II Jan-14-2022
39 Siemens Medical Solutions USA, Inc II Apr-19-2021
40 Siemens Medical Solutions USA, Inc II Mar-04-2021
41 Siemens Medical Solutions USA, Inc II Aug-28-2020
42 Siemens Medical Solutions USA, Inc II Feb-23-2019
43 Siemens Medical Solutions USA, Inc II Jul-06-2017
44 Siemens Medical Solutions USA, Inc II May-24-2017
45 Spacelabs Healthcare, Inc. II Jul-22-2019
46 Spacelabs Healthcare, Ltd. II Dec-10-2020
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