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


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 4
ABBOTT ELECTROPHYSIOLOGY
  SUBSTANTIALLY EQUIVALENT 2
ABBOTT MEDICAL
  SUBSTANTIALLY EQUIVALENT 4
ABLACON, INC.
  SUBSTANTIALLY EQUIVALENT 1
ACUTUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 8
ADAMS MEDITECH LLC
  SUBSTANTIALLY EQUIVALENT 1
ALIVECOR, INC.
  SUBSTANTIALLY EQUIVALENT 2
APN HEALTH, LLC
  SUBSTANTIALLY EQUIVALENT 1
BIOFOURMIS SINGAPORE PTE. LTD.
  SUBSTANTIALLY EQUIVALENT 1
BIOSENSE WEBSTER, INC.
  SUBSTANTIALLY EQUIVALENT 7
BIOSIG TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 8
CARDIO TEK, BV
  SUBSTANTIALLY EQUIVALENT 1
CARDIOINSIGHT TECHNOLOGIES, INC
  SUBSTANTIALLY EQUIVALENT 1
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
IMPLICITY, INC.
  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
SIEMENS MEDICAL SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPACELABS HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 2
ST. JUDE MEDICAL
  SUBSTANTIALLY EQUIVALENT 7
ST. JUDE MEDICAL (NOW ABBOTT MEDICAL)
  SUBSTANTIALLY EQUIVALENT 1
ST. JUDE MEDICAL (NOW PART OF THE ABBOTT MEDICAL)
  SUBSTANTIALLY EQUIVALENT 1
TELEMED SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
TOPERA, INC.
  SUBSTANTIALLY EQUIVALENT 1
VEKTOR MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
VOLTA MEDICAL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 131 131
2016 340 340
2017 252 252
2018 261 261
2019 218 218
2020 215 215
2021 276 276

Device Problems MDRs with this Device Problem Events in those MDRs
Communication or Transmission Problem 212 212
Application Interface Becomes Non-Functional Or Program Exits Abnormally 121 121
Display or Visual Feedback Problem 93 93
Device Issue 90 90
Device Operational Issue 88 88
Incorrect Measurement 83 83
Image Orientation Incorrect 81 81
Failure to Transmit Record 77 77
Device Displays Incorrect Message 74 74
Data Problem 73 73
Device Operates Differently Than Expected 72 72
No Display/Image 71 71
Application Program Problem 64 64
Incorrect, Inadequate or Imprecise Resultor Readings 59 59
Adverse Event Without Identified Device or Use Problem 54 54
Computer Software Problem 51 51
Signal Artifact/Noise 49 49
Failure to Power Up 48 48
Output Problem 46 46
Failure of Device to Self-Test 35 35
Pacing Problem 33 33
Retraction Problem 31 31
Erratic or Intermittent Display 30 30
Noise, Audible 30 30
Patient Data Problem 26 26
Smoking 26 26
Use of Device Problem 25 25
Blocked Connection 25 25
Insufficient Information 23 23
Unexpected Shutdown 21 21
Power Problem 20 20
Connection Problem 19 19
Appropriate Term/Code Not Available 18 18
Device Alarm System 18 18
Sparking 17 17
Application Program Version or Upgrade Problem 16 16
Computer Operating System Problem 16 16
Loss of Data 15 15
Improper Device Output 14 14
Failure to Cycle 14 14
Overheating of Device 14 14
No Device Output 13 13
Failure to Analyze Signal 11 11
Image Display Error/Artifact 11 11
Application Program Freezes, Becomes Nonfunctional 11 11
Device Emits Odor 10 10
Loss of Power 8 8
Patient Device Interaction Problem 8 8
Malposition of Device 8 8
Loose or Intermittent Connection 8 8
Positioning Problem 8 8
Difficult to Remove 8 8
Battery Problem 8 8
Device Inoperable 7 7
Intermittent Communication Failure 7 7
No Pacing 7 7
Electrical /Electronic Property Problem 7 7
Thermal Decomposition of Device 7 7
Radio Signal Problem 7 7
Disconnection 6 6
Break 6 6
Improper or Incorrect Procedure or Method 6 6
Over-Sensing 5 5
Fire 5 5
Material Twisted/Bent 5 5
Self-Activation or Keying 5 5
No Apparent Adverse Event 5 5
Failure to Align 5 5
Loss of Threshold 5 5
Failure to Zero 4 4
Material Deformation 4 4
Use of Incorrect Control Settings 4 4
Application Network Problem 4 4
Nonstandard Device 4 4
Impedance Problem 4 4
Therapeutic or Diagnostic Output Failure 4 4
Device Remains Activated 4 4
High Readings 4 4
Migration or Expulsion of Device 4 4
Failure to Read Input Signal 4 4
Device Stops Intermittently 4 4
Issue With Displayed Error Message 4 4
Material Integrity Problem 4 4
Device Sensing Problem 3 3
Inappropriate/Inadequate Shock/Stimulation 3 3
Power Conditioning Problem 3 3
Decoupling 3 3
Bent 3 3
Operating System Becomes Nonfunctional 3 3
Unintended Application Program Shut Down 3 3
High impedance 3 3
Failure to Select Signal 3 3
Mechanical Problem 3 3
Defective Device 3 3
Calibration Problem 3 3
Detachment of Device or Device Component 3 3
Inadequate User Interface 3 3
Environmental Compatibility Problem 3 3
Failure to Deliver Energy 3 3
Unintended Movement 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 690 690
No Known Impact Or Consequence To Patient 565 565
No Clinical Signs, Symptoms or Conditions 275 275
No Patient Involvement 42 42
Insufficient Information 21 21
Death 20 20
No Information 18 19
Cardiac Perforation 14 14
No Code Available 13 13
Cardiac Arrest 11 11
Cardiac Tamponade 9 9
Ventricular Fibrillation 8 8
Tissue Damage 8 8
Arrhythmia 6 6
Atrial Fibrillation 6 6
Skin Tears 6 6
Low Blood Pressure/ Hypotension 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Burn(s) 4 4
Complete Heart Block 4 4
Sudden Cardiac Death 4 4
Non specific EKG/ECG Changes 4 4
Complaint, Ill-Defined 3 3
Ventricular Tachycardia 3 3
Fall 3 3
Electric Shock 3 3
Partial thickness (Second Degree) Burn 3 3
Rash 2 2
Pain 2 2
Missing Value Reason 2 2
Myocardial Infarction 2 2
Inflammation 2 2
Heart Block 2 2
Reaction 2 2
Sepsis 2 2
Pericardial Effusion 1 1
Impaired Healing 1 1
Antibiotics, Reaction To 1 1
Respiratory Distress 1 1
Seizures 1 1
Tachycardia 1 1
Test Result 1 1
Asystole 1 1
Bradycardia 1 1
Bone Fracture(s) 1 1
Swelling 1 1
Weight Changes 1 1
Patient Problem/Medical Problem 1 1
Bruise/Contusion 1 1
Hemorrhage/Bleeding 1 1
Hematoma 1 1
Respiratory Failure 1 1
Dyspnea 1 1
Scarring 1 1
Fistula 1 1
Itching Sensation 1 1
Cardiogenic Shock 1 1
Discomfort 1 1
Fever 1 1
Sweating 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 Biosense Webster, Inc. II Oct-01-2015
5 Boston Scientific Corporation II Apr-27-2020
6 CHANGE HEALTHCARE CANADA COMPANY II Apr-08-2020
7 CardioTek BV II Jun-30-2017
8 Change Healthcare Israel Ltd. II May-24-2019
9 Edwards Lifesciences, LLC II May-08-2020
10 Edwards Lifesciences, LLC II Jan-16-2018
11 Fujifilm Medical Systems U.S.A., Inc. II May-14-2015
12 Fujifilm Medical Systems U.S.A., Inc. II May-14-2015
13 GE Healthcare Finland Oy II Oct-10-2018
14 GE Healthcare Finland Oy II Jul-02-2018
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 Jan-25-2018
19 Hitachi Healthcare Americas Corp Informatics Division II Sep-06-2018
20 Invivo Corporation II Nov-14-2018
21 McKesson Israel Ltd. II Aug-31-2018
22 McKesson Israel Ltd. II Jan-05-2015
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 Merge Healthcare, Inc. II Nov-28-2016
33 Merge Healthcare, Inc. II Aug-04-2016
34 Merge Healthcare, Inc. II Dec-28-2015
35 Merge Healthcare, Inc. II Aug-06-2015
36 Philips Electronics North America Corporation II Dec-14-2018
37 Siemens Medical Solutions USA, Inc II Apr-19-2021
38 Siemens Medical Solutions USA, Inc II Mar-04-2021
39 Siemens Medical Solutions USA, Inc II Aug-28-2020
40 Siemens Medical Solutions USA, Inc II Feb-23-2019
41 Siemens Medical Solutions USA, Inc II Jul-06-2017
42 Siemens Medical Solutions USA, Inc II May-24-2017
43 Spacelabs Healthcare, Inc. II Jul-22-2019
44 Spacelabs Healthcare, Ltd. II Dec-10-2020
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