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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
Regulation Description Programmable diagnostic computer.
Product CodeDQK
Regulation Number 870.1425
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 3
ABBOTT ELECTROPHYSIOLOGY
  SUBSTANTIALLY EQUIVALENT 2
ABBOTT MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
ABLACON, INC.
  SUBSTANTIALLY EQUIVALENT 1
ACUTUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 8
ALIVECOR, INC.
  SUBSTANTIALLY EQUIVALENT 2
APN HEALTH, LLC
  SUBSTANTIALLY EQUIVALENT 1
BIOFOURMIS SINGAPORE PTE. LTD.
  SUBSTANTIALLY EQUIVALENT 1
BIOSENSE WEBSTER, INC.
  SUBSTANTIALLY EQUIVALENT 6
BIOSIG TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 6
CARDIO TEK, BV
  SUBSTANTIALLY EQUIVALENT 1
  1.  K161245  EP-TRACER System
CARDIOINSIGHT TECHNOLOGIES, INC
  SUBSTANTIALLY EQUIVALENT 1
CARDIONXT, INC.
  SUBSTANTIALLY EQUIVALENT 1
CAREFUSION GERMANY 234 GMBH
  SUBSTANTIALLY EQUIVALENT 1
CATHETER PRECISION, INC.
  SUBSTANTIALLY EQUIVALENT 2
CENTERLINE BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
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 LIFESCIENCES, LLC
  SUBSTANTIALLY EQUIVALENT 5
EDWARDS LIFESIENCES, LLC
  SUBSTANTIALLY EQUIVALENT 1
EPIPHANY HEALTHCARE, LLC
  SUBSTANTIALLY EQUIVALENT 1
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG
  SUBSTANTIALLY EQUIVALENT 1
IRHYTHM TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 3
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
MERGE HEALTHCARE INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
MORTARA INSTRUMENT, INC.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEM NEDERLAND B.V.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
  SUBSTANTIALLY EQUIVALENT 1
SCHWARZER CARDIOTEK GMBH
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN CAREWELL ELECTRONICS., LTD
  SUBSTANTIALLY EQUIVALENT 1
SPACELABS HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 2
ST. JUDE MEDICAL
  SUBSTANTIALLY EQUIVALENT 6
ST. JUDE MEDICAL (NOW ABBOTT MEDICAL)
  SUBSTANTIALLY EQUIVALENT 1
ST. JUDE MEDICAL (NOW PART OF THE ABBOTT MEDICAL)
  SUBSTANTIALLY EQUIVALENT 1
VOLTA MEDICAL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 340 340
2017 252 252
2018 261 261
2019 218 218
2020 215 215
2021 240 240

Device Problems MDRs with this Device Problem Events in those MDRs
Communication or Transmission Problem 197 197
Application Interface Becomes Non-Functional Or Program Exits Abnormally 113 113
Device Issue 90 90
Device Operational Issue 88 88
Image Orientation Incorrect 81 81
Display or Visual Feedback Problem 79 79
Failure to Transmit Record 77 77
Incorrect Measurement 75 75
Data Problem 70 70
Application Program Problem 62 62
Incorrect, Inadequate or Imprecise Resultor Readings 59 59
No Display/Image 57 57
Device Operates Differently Than Expected 53 53
Adverse Event Without Identified Device or Use Problem 51 51
Computer Software Problem 50 50
Failure to Power Up 46 46
Output Problem 44 44
Device Displays Incorrect Message 44 44
Signal Artifact/Noise 38 38
Failure of Device to Self-Test 34 34
Retraction Problem 31 31
Blocked Connection 25 25
Patient Data Problem 25 25
Erratic or Intermittent Display 24 24
Pacing Problem 23 23
Smoking 23 23
Use of Device Problem 23 23
Noise, Audible 21 21
Unexpected Shutdown 20 20
Insufficient Information 19 19
Power Problem 19 19
Appropriate Term/Code Not Available 18 18
Sparking 17 17
Application Program Version or Upgrade Problem 16 16
Connection Problem 15 15
Improper Device Output 14 14
Failure to Cycle 14 14
No Device Output 13 13
Overheating of Device 12 12
Loss of Data 11 11
Failure to Analyze Signal 11 11
Application Program Freezes, Becomes Nonfunctional 11 11
Device Alarm System 10 10
Computer Operating System Problem 10 10
Device Emits Odor 9 9
Difficult to Remove 8 8
Patient Device Interaction Problem 8 8
Loose or Intermittent Connection 8 8
Battery Problem 8 8
Positioning Problem 7 7
Thermal Decomposition of Device 7 7
Intermittent Communication Failure 7 7
No Pacing 6 6
Electrical /Electronic Property Problem 6 6
Disconnection 6 6
Image Display Error/Artifact 6 6
Loss of Power 6 6
Fire 5 5
Failure to Align 5 5
Self-Activation or Keying 5 5
Malposition of Device 5 5
Loss of Threshold 5 5
Improper or Incorrect Procedure or Method 5 5
Device Inoperable 4 4
Failure to Zero 4 4
High Readings 4 4
Issue With Displayed Error Message 4 4
Material Deformation 4 4
Failure to Read Input Signal 4 4
Material Integrity Problem 4 4
Application Network Problem 4 4
Therapeutic or Diagnostic Output Failure 4 4
Migration or Expulsion of Device 4 4
Nonstandard Device 4 4
Use of Incorrect Control Settings 4 4
Break 4 4
Bent 3 3
Failure to Deliver Energy 3 3
No Apparent Adverse Event 3 3
Material Twisted/Bent 3 3
Operating System Becomes Nonfunctional 3 3
Calibration Problem 3 3
Detachment of Device or Device Component 3 3
Inadequate User Interface 3 3
Environmental Compatibility Problem 3 3
Unintended Application Program Shut Down 3 3
Device Remains Activated 3 3
Unintended Movement 3 3
Device Sensing Problem 3 3
Electrical Shorting 3 3
Impedance Problem 3 3
Leak/Splash 2 2
Electronic Property Issue 2 2
Fitting Problem 2 2
Invalid Sensing 2 2
High Test Results 2 2
Power Conditioning Problem 2 2
Product Quality Problem 2 2
Poor Quality Image 2 2
Unintended System Motion 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 632 632
No Known Impact Or Consequence To Patient 518 518
No Clinical Signs, Symptoms or Conditions 243 243
No Patient Involvement 41 41
Insufficient Information 18 18
Death 15 15
Cardiac Perforation 14 14
No Information 13 13
Cardiac Arrest 9 9
Ventricular Fibrillation 8 8
No Code Available 8 8
Tissue Damage 7 7
Cardiac Tamponade 7 7
Skin Tears 6 6
Arrhythmia 6 6
Atrial Fibrillation 4 4
Sudden Cardiac Death 4 4
Burn(s) 4 4
Non specific EKG/ECG Changes 4 4
Low Blood Pressure/ Hypotension 4 4
Fall 3 3
Complete Heart Block 3 3
Partial thickness (Second Degree) Burn 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Electric Shock 3 3
Reaction 2 2
Missing Value Reason 2 2
Heart Block 2 2
Complaint, Ill-Defined 2 2
Myocardial Infarction 2 2
Ventricular Tachycardia 2 2
Inflammation 2 2
Rash 2 2
Sepsis 1 1
Hematoma 1 1
Respiratory Failure 1 1
Pericardial Effusion 1 1
Pain 1 1
Respiratory Distress 1 1
Scarring 1 1
Impaired Healing 1 1
Cardiogenic Shock 1 1
Discomfort 1 1
Bradycardia 1 1
Bruise/Contusion 1 1
Antibiotics, Reaction To 1 1
Bone Fracture(s) 1 1
Itching Sensation 1 1
Patient Problem/Medical Problem 1 1
Test Result 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 Biosense Webster, Inc. II Sep-09-2016
4 Boston Scientific Corporation II Apr-27-2020
5 CHANGE HEALTHCARE CANADA COMPANY II Apr-08-2020
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 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 Merge Healthcare, Inc. II Jul-10-2017
22 Merge Healthcare, Inc. II Jun-29-2017
23 Merge Healthcare, Inc. II May-02-2017
24 Merge Healthcare, Inc. II Apr-11-2017
25 Merge Healthcare, Inc. II Mar-14-2017
26 Merge Healthcare, Inc. II Feb-15-2017
27 Merge Healthcare, Inc. II Jan-24-2017
28 Merge Healthcare, Inc. II Nov-28-2016
29 Merge Healthcare, Inc. II Aug-04-2016
30 Philips Electronics North America Corporation II Dec-14-2018
31 Siemens Medical Solutions USA, Inc II Apr-19-2021
32 Siemens Medical Solutions USA, Inc II Mar-04-2021
33 Siemens Medical Solutions USA, Inc II Aug-28-2020
34 Siemens Medical Solutions USA, Inc II Feb-23-2019
35 Siemens Medical Solutions USA, Inc II Jul-06-2017
36 Siemens Medical Solutions USA, Inc II May-24-2017
37 Spacelabs Healthcare, Inc. II Jul-22-2019
38 Spacelabs Healthcare, Ltd. II Dec-10-2020
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