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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 2
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
ADAMS MEDITECH LLC
  SUBSTANTIALLY EQUIVALENT 1
ALIVECOR, INC.
  SUBSTANTIALLY EQUIVALENT 3
ANUMANA, INC
  SUBSTANTIALLY EQUIVALENT 1
APN HEALTH, LLC
  SUBSTANTIALLY EQUIVALENT 1
BIOFOURMIS SINGAPORE PTE. LTD.
  SUBSTANTIALLY EQUIVALENT 1
BIOSENSE WEBSTER, INC.
  SUBSTANTIALLY EQUIVALENT 19
BIOSIG TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 9
C.R. BARD INC., BARD ELECTROPHYSIOLOGY DIVISION
  SUBSTANTIALLY EQUIVALENT 2
CAMBRIDGE HEART, INC.
  SUBSTANTIALLY EQUIVALENT 1
CARDIAC DESIGNS, LLC
  SUBSTANTIALLY EQUIVALENT 1
CARDIO TEK, BV
  SUBSTANTIALLY EQUIVALENT 1
CARDIOCALM SRL
  SUBSTANTIALLY EQUIVALENT 1
CARDIOINSIGHT TECHNOLOGIES, INC
  SUBSTANTIALLY EQUIVALENT 2
CARDIOINSIGHT TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
CARDIONXT, INC.
  SUBSTANTIALLY EQUIVALENT 1
CARDIOTEK, B.V.
  SUBSTANTIALLY EQUIVALENT 1
CAREFUSION GERMANY 234 GMBH
  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
EDAN INSTRUMENTS, INC.
  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
  SUBSTANTIALLY EQUIVALENT 1
GE HEALTHCARE INFORMATION TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 2
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES GMBH
  SUBSTANTIALLY EQUIVALENT 1
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 7
GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG
  SUBSTANTIALLY EQUIVALENT 2
IMPLICITY, INC.
  SUBSTANTIALLY EQUIVALENT 1
IRHYTHM TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 7
ITAMAR MEDICAL, LTD.
  SUBSTANTIALLY EQUIVALENT 1
LUMEDX
  SUBSTANTIALLY EQUIVALENT 1
MCKESSON ISRAEL LTD.
  SUBSTANTIALLY EQUIVALENT 2
MEDICALGORITHMICS S.A.
  SUBSTANTIALLY EQUIVALENT 1
MEDIGUIDE, LTD.
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 2
MENNEN MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
MERGE HEALTHCARE INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
MORTARA INSTRUMENT, INC.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS HEALTHCARE
  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
RADI MEDICAL SYSTEMS AB
  SUBSTANTIALLY EQUIVALENT 2
RHYTHM AL, LTD
  SUBSTANTIALLY EQUIVALENT 1
RHYTHMIA MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
SCHWARZER CARDIOTEK GMBH
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN CAREWELL ELECTRONICS., LTD
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS MEDICAL SOLUTIONS USA INC.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS MEDICAL SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 2
SMART SOLUTIONS TECHNOLOGIES SL
  SUBSTANTIALLY EQUIVALENT 1
SPACELABS HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1
SPACELABS HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 3
ST. JUDE MEDICAL
  SUBSTANTIALLY EQUIVALENT 20
ST. JUDE MEDICAL (NOW ABBOTT MEDICAL)
  SUBSTANTIALLY EQUIVALENT 1
ST. JUDE MEDICAL (NOW PART OF THE ABBOTT MEDICAL)
  SUBSTANTIALLY EQUIVALENT 1
ST. JUDE MEDICAL, MEDIGUIDE NAVIGATION SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
STEREOTAXIS, INC.
  SUBSTANTIALLY EQUIVALENT 1
TELEMED SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
TOMTEC IMAGING SYSTEMS, GMBH
  SUBSTANTIALLY EQUIVALENT 2
TOPERA, INC.
  SUBSTANTIALLY EQUIVALENT 5
VEKTOR MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
VOLTA MEDICAL
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2014 115 115
2015 131 131
2016 340 340
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 409 409
Display or Visual Feedback Problem 294 294
Failure to Transmit Record 168 168
Incorrect Measurement 141 141
Signal Artifact/Noise 127 127
Application Interface Becomes Non-Functional Or Program Exits Abnormally 124 124
Device Displays Incorrect Message 94 94
Incorrect, Inadequate or Imprecise Result or Readings 93 93
Device Issue 90 90
Device Operates Differently Than Expected 90 90
Output Problem 89 89
Application Program Problem 88 88
Device Operational Issue 88 88
No Display/Image 86 86
Image Orientation Incorrect 81 81
Data Problem 80 80
Computer Software Problem 68 68
Failure of Device to Self-Test 64 64
Pacing Problem 61 61
Adverse Event Without Identified Device or Use Problem 61 61
Failure to Power Up 59 59
Noise, Audible 46 46
Erratic or Intermittent Display 41 41
Smoking 37 37
Use of Device Problem 36 36
Unexpected Shutdown 34 34
Retraction Problem 31 31
Appropriate Term/Code Not Available 31 31
Patient Data Problem 30 30
Computer Operating System Problem 29 29
Device Alarm System 29 29
Power Problem 29 29
Insufficient Information 26 26
Blocked Connection 25 25
Connection Problem 24 24
Patient Device Interaction Problem 23 23
Impedance Problem 21 21
Device Emits Odor 20 20
Poor Quality Image 20 20
Sparking 20 20
Electrical /Electronic Property Problem 19 19
Electromagnetic Interference 19 19
Overheating of Device 18 18
No Device Output 17 17
Application Program Version or Upgrade Problem 17 17
Loss of Data 16 16
Loose or Intermittent Connection 16 16
Inaccurate Information 15 15
Improper Device Output 15 15
Failure to Cycle 14 14
Image Display Error/Artifact 14 14
Positioning Problem 14 14
Thermal Decomposition of Device 14 14
Material Twisted/Bent 13 13
Material Integrity Problem 13 13
Application Program Freezes, Becomes Nonfunctional 13 13
No Pacing 12 12
Fire 12 12
Malposition of Device 12 12
Failure to Analyze Signal 11 11
Defective Device 11 11
Device Inoperable 11 11
Battery Problem 9 9
Difficult to Remove 9 9
Loss of Power 9 9
Radio Signal Problem 8 8
Electrical Shorting 8 8
Break 8 8
Mechanical Problem 7 7
Disconnection 7 7
Operating System Version or Upgrade Problem 7 7
Improper or Incorrect Procedure or Method 7 7
Intermittent Communication Failure 7 7
No Apparent Adverse Event 7 7
High Readings 6 6
Fitting Problem 6 6
Failure to Align 6 6
Unintended Movement 5 5
Loss of Threshold 5 5
Failure to Deliver Energy 5 5
Application Network Problem 5 5
High impedance 5 5
Self-Activation or Keying 5 5
Over-Sensing 5 5
Failure to Read Input Signal 5 5
Device Sensing Problem 5 5
Migration or Expulsion of Device 5 5
Operating System Becomes Nonfunctional 5 5
Bent 4 4
Unintended Application Program Shut Down 4 4
Unintended Electrical Shock 4 4
Issue With Displayed Error Message 4 4
Device Stops Intermittently 4 4
No Visual Prompts/Feedback 4 4
Power Conditioning Problem 4 4
Inappropriate/Inadequate Shock/Stimulation 4 4
Device Remains Activated 4 4
Unintended System Motion 4 4
Therapeutic or Diagnostic Output Failure 4 4
Activation, Positioning or Separation Problem 4 4

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 727 727
No Known Impact Or Consequence To Patient 619 619
Unspecified Heart Problem 98 98
No Patient Involvement 42 42
Insufficient Information 34 34
No Information 24 25
Cardiac Perforation 24 24
Death 22 22
No Code Available 18 18
Cardiac Arrest 14 14
Arrhythmia 12 12
Cardiac Tamponade 11 11
Skin Tears 9 9
Atrial Fibrillation 9 9
Tissue Damage 9 9
Ventricular Fibrillation 8 8
Low Blood Pressure/ Hypotension 8 8
Burn(s) 5 5
Electric Shock 5 5
Shock 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Complete Heart Block 5 5
Sudden Cardiac Death 4 4
Ventricular Tachycardia 4 4
Non specific EKG/ECG Changes 4 4
Fall 3 3
Stroke/CVA 3 3
Partial thickness (Second Degree) Burn 3 3
Pericardial Effusion 3 3
Heart Block 3 3
Complaint, Ill-Defined 3 3
Reaction 2 2
Asystole 2 2
Missing Value Reason 2 2
Tachycardia 2 2
Hemorrhage/Bleeding 2 2
Sepsis 2 2
Myocardial Infarction 2 2
Inflammation 2 2
Pain 2 2
Perforation 2 2
Rash 2 2
Respiratory Distress 1 1
Scarring 1 1
Seizures 1 1
Itching Sensation 1 1
Failure of Implant 1 1
Nerve Damage 1 1
Device Overstimulation of Tissue 1 1
Misdiagnosis 1 1
High Blood Pressure/ Hypertension 1 1
Dyspnea 1 1
Fever 1 1
Fistula 1 1
Bone Fracture(s) 1 1
Hematoma 1 1
Anaphylactic Shock 1 1
Antibiotics, Reaction To 1 1
Atrial Flutter 1 1
Atrial Tachycardia 1 1
Bradycardia 1 1
Bruise/Contusion 1 1
Patient Problem/Medical Problem 1 1
Test Result 1 1
Syncope/Fainting 1 1
Sweating 1 1
Needle Stick/Puncture 1 1
Respiratory Failure 1 1
Missed Dose 1 1
Diminished Pulse Pressure 1 1
Weight Changes 1 1
Impaired Healing 1 1
Swelling 1 1
Cardiogenic Shock 1 1
Discomfort 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 Biosense Webster, Inc. II Sep-09-2016
6 Biosense Webster, Inc. II Oct-01-2015
7 Biosense Webster, Inc. II Feb-20-2014
8 Biosense Webster, Inc. II Mar-28-2013
9 Biosense Webster, Inc. II Sep-12-2012
10 Biosense Webster, Inc. II Mar-20-2012
11 Biosense Webster, Inc. III Mar-28-2011
12 Boston Scientific Corporation II Apr-27-2020
13 CHANGE HEALTHCARE CANADA COMPANY II Apr-08-2020
14 CardioTek BV II Jun-23-2022
15 CardioTek BV II Jun-30-2017
16 Change Healthcare Israel Ltd. II May-24-2019
17 Edwards Lifesciences, LLC II May-08-2020
18 Edwards Lifesciences, LLC II Jan-16-2018
19 Fujifilm Medical Systems U.S.A., Inc. II May-14-2015
20 Fujifilm Medical Systems U.S.A., Inc. II May-14-2015
21 GE Healthcare Finland Oy II Oct-10-2018
22 GE Healthcare Finland Oy II Jul-02-2018
23 GE Healthcare, LLC II Apr-13-2022
24 GE Healthcare, LLC II Jun-22-2021
25 GE Healthcare, LLC II Oct-31-2019
26 GE Healthcare, LLC II Jul-23-2019
27 GE Healthcare, LLC II Apr-17-2013
28 GE Healthcare, LLC II Aug-14-2009
29 GE Medical Systems Information Technologies Inc II Sep-19-2023
30 GE Medical Systems Information Technologies, Inc. II Jan-25-2018
31 Hitachi Healthcare Americas Corp Informatics Division II Sep-06-2018
32 Invivo Corporation II Nov-14-2018
33 McKesson Israel Ltd. II Aug-31-2018
34 McKesson Israel Ltd. II Jan-05-2015
35 McKesson Provider Technologies - Medical Imaging Group II Jan-13-2011
36 McKesson Provider Technologies - Medical Imaging Group II Jul-09-2010
37 McKesson Provider Technologies - Medical Imaging Group II Jun-24-2010
38 Merge Healthcare, Inc. II Aug-28-2021
39 Merge Healthcare, Inc. II Jan-14-2018
40 Merge Healthcare, Inc. II Jul-10-2017
41 Merge Healthcare, Inc. II Jun-29-2017
42 Merge Healthcare, Inc. II May-02-2017
43 Merge Healthcare, Inc. II Apr-11-2017
44 Merge Healthcare, Inc. II Mar-14-2017
45 Merge Healthcare, Inc. II Feb-15-2017
46 Merge Healthcare, Inc. II Jan-24-2017
47 Merge Healthcare, Inc. II Nov-28-2016
48 Merge Healthcare, Inc. II Aug-04-2016
49 Merge Healthcare, Inc. II Dec-28-2015
50 Merge Healthcare, Inc. II Aug-06-2015
51 Merge Healthcare, Inc. II Oct-28-2014
52 Philips Electronics North America Corporation II Dec-14-2018
53 Philips Medical Systems, Inc. II Aug-21-2014
54 Siemens Medical Solutions USA, Inc II Jan-09-2024
55 Siemens Medical Solutions USA, Inc II Jan-01-2023
56 Siemens Medical Solutions USA, Inc III Aug-18-2022
57 Siemens Medical Solutions USA, Inc II Jul-20-2022
58 Siemens Medical Solutions USA, Inc II Jun-06-2022
59 Siemens Medical Solutions USA, Inc II Jan-14-2022
60 Siemens Medical Solutions USA, Inc II Apr-19-2021
61 Siemens Medical Solutions USA, Inc II Mar-04-2021
62 Siemens Medical Solutions USA, Inc II Aug-28-2020
63 Siemens Medical Solutions USA, Inc II Feb-23-2019
64 Siemens Medical Solutions USA, Inc II Jul-06-2017
65 Siemens Medical Solutions USA, Inc II May-24-2017
66 Siemens Medical Solutions USA, Inc II May-10-2012
67 Spacelabs Healthcare, Inc. II Jul-22-2019
68 Spacelabs Healthcare, Incorporated II Aug-25-2010
69 Spacelabs Healthcare, Llc II Mar-25-2014
70 Spacelabs Healthcare, Llc II Jan-17-2013
71 Spacelabs Healthcare, Llc II Jun-20-2012
72 Spacelabs Healthcare, Llc II Jun-22-2011
73 Spacelabs Healthcare, Ltd. II Dec-10-2020
74 St. Jude Medical II Apr-10-2009
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