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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 4
ABBOTT LABORATORIES
  SUBSTANTIALLY EQUIVALENT 10
ADAMS MEDITECH LLC
  SUBSTANTIALLY EQUIVALENT 1
ALIVECOR, INC.
  SUBSTANTIALLY EQUIVALENT 2
BIOSENSE
  SUBSTANTIALLY EQUIVALENT 5
BIOSENSE WEBSTER, INC.
  SUBSTANTIALLY EQUIVALENT 5
BOSTON SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 7
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 6
CARDIOINSIGHT TECHNOLOGIES, INC
  SUBSTANTIALLY EQUIVALENT 1
CAREFUSION
  SUBSTANTIALLY EQUIVALENT 1
EDAN INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
EDWARDS LIFESCIENCES
  SUBSTANTIALLY EQUIVALENT 4
EDWARDS LIFESCIENCES, LLC
  SUBSTANTIALLY EQUIVALENT 4
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
GETEMED
  SUBSTANTIALLY EQUIVALENT 1
GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG
  SUBSTANTIALLY EQUIVALENT 1
IRHYTHM TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
MERGE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1
MORTARA
  SUBSTANTIALLY EQUIVALENT 1
MORTARA INSTRUMENT, INC.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS INTERNATIONAL BV
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS
  SUBSTANTIALLY EQUIVALENT 1
SPACELABS HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1
SPACELABS HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 1
ST. JUDE MEDICAL (ABBOTT LABORATORIES)
  SUBSTANTIALLY EQUIVALENT 2
ST. JUDE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 7

MDR Year MDR Reports MDR Events
2015 131 131
2016 340 340
2017 252 252
2018 261 261
2019 218 218
2020 168 168

Device Problems MDRs with this Device Problem Events in those MDRs
Communication or Transmission Problem 156 156
Application Interface Becomes Non-Functional Or Program Exits Abnormally 121 121
Device Issue 90 90
Device Operational Issue 88 88
Image Orientation Incorrect 77 77
Failure to Transmit Record 75 75
Device Operates Differently Than Expected 72 72
Device Displays Incorrect Message 69 69
Data Problem 69 69
No Display/Image 56 56
Computer Software Problem 45 45
Adverse Event Without Identified Device or Use Problem 44 44
Application Program Problem 43 43
Incorrect, Inadequate or Imprecise Resultor Readings 38 38
Signal Artifact/Noise 37 37
Failure to Power Up 36 36
Output Problem 32 32
Retraction Problem 31 31
Incorrect Measurement 30 30
Display or Visual Feedback Problem 29 29
EKG/ECG Monitor 28 28
Pacing Problem 28 28
Failure of Device to Self-Test 27 27
Blocked Connection 25 25
Use of Device Problem 24 24
Cable, Electrical 24 24
Noise, Audible 24 24
Erratic or Intermittent Display 24 24
Insufficient Information 20 20
Patient Data Problem 19 19
Smoking 18 18
Device Alarm System 18 18
Power Problem 18 18
Connection Problem 17 17
Appropriate Term/Code Not Available 16 16
Loss of Data 15 15
Improper Device Output 14 14
Failure to Cycle 14 14
Overheating of Device 14 14
Sparking 13 13
Computer Operating System Problem 12 12
No Device Output 11 11
Image Display Error/Artifact 11 11
Application Program Freezes, Becomes Nonfunctional 10 10
Failure to Analyze Signal 9 9
Malposition of Device 8 8
Monitor 8 8
Positioning Problem 8 8
Device Emits Odor 8 8
Catheter 8 8
Difficult to Remove 8 8
Radio Signal Problem 7 7
Battery Problem 7 7
Device Inoperable 7 7
Fuse 6 6
Battery 6 6
Disconnection 6 6
Loose or Intermittent Connection 6 6
Intermittent Communication Failure 6 6
Computer Hardware 6 6
Device Component Or Accessory 6 6
No Apparent Adverse Event 5 5
Failure to Align 5 5
Break 5 5
No Pacing 5 5
Electrical /Electronic Property Problem 5 5
Over-Sensing 5 5
Self-Activation or Keying 4 4
Failure to Read Input Signal 4 4
Device Stops Intermittently 4 4
Failure to Zero 4 4
Improper or Incorrect Procedure or Method 4 4
High Readings 4 4
Thermal Decomposition of Device 4 4
Issue With Displayed Error Message 4 4
Impedance Problem 4 4
Use of Incorrect Control Settings 4 4
Migration or Expulsion of Device 4 4
Nonstandard Device 4 4
Fire 4 4
Application Network Problem 4 4
Calibration Problem 3 3
Loss of Power 3 3
Detachment of Device or Device Component 3 3
Environmental Compatibility Problem 3 3
EKG/ECG Subassembly (Only Use When Part Of Another Device) 3 3
Bent 3 3
Unexpected Shutdown 3 3
Therapeutic or Diagnostic Output Failure 3 3
Material Deformation 3 3
Unintended Movement 3 3
Interface 3 3
Connector 3 3
High impedance 3 3
Decoupling 3 3
Failure to Select Signal 3 3
Inappropriate/Inadequate Shock/Stimulation 3 3
Device Remains Activated 3 3
Leak/Splash 3 3
Unintended System Motion 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 627 627
No Known Impact Or Consequence To Patient 562 562
No Patient Involvement 42 42
Death 20 20
No Information 18 19
No Code Available 13 13
No Clinical Signs, Symptoms or Conditions 11 11
Cardiac Arrest 10 10
Cardiac Tamponade 9 9
Tissue Damage 8 8
Ventricular Fibrillation 8 8
Atrial Fibrillation 6 6
Cardiac Perforation 6 6
Arrhythmia 5 5
Low Blood Pressure/ Hypotension 5 5
Skin Tears 5 5
Complete Heart Block 4 4
Non specific EKG/ECG Changes 4 4
Burn(s) 4 4
Sudden Cardiac Death 4 4
Ventricular Tachycardia 3 3
Fall 3 3
Partial thickness (Second Degree) Burn 3 3
Complaint, Ill-Defined 3 3
Electric Shock 2 2
Missing Value Reason 2 2
Myocardial Infarction 2 2
Pain 2 2
Inflammation 2 2
Sepsis 2 2
Swelling 1 1
Fever 1 1
Hematoma 1 1
Dyspnea 1 1
Sweating 1 1
Respiratory Failure 1 1
Pericardial Effusion 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Respiratory Distress 1 1
Scarring 1 1
Seizures 1 1
Tachycardia 1 1
Cardiogenic Shock 1 1
Discomfort 1 1
Antibiotics, Reaction To 1 1
Bradycardia 1 1
Bruise/Contusion 1 1
Fistula 1 1
Bone Fracture(s) 1 1
Hemorrhage/Bleeding 1 1
Patient Problem/Medical Problem 1 1
Test Result 1 1
Weight Changes 1 1
Impaired Healing 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Biosense Webster (israel), Ltd. II Aug-24-2020
2 Biosense Webster, Inc. II Sep-09-2016
3 Biosense Webster, Inc. II Oct-01-2015
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 Fujifilm Medical Systems U.S.A., Inc. II May-14-2015
11 Fujifilm Medical Systems U.S.A., Inc. II May-14-2015
12 GE Healthcare Finland Oy II Oct-10-2018
13 GE Healthcare Finland Oy II Jul-02-2018
14 GE Healthcare, LLC II Oct-31-2019
15 GE Healthcare, LLC II Jul-23-2019
16 GE Medical Systems Information Technologies, Inc. II Jan-25-2018
17 Hitachi Healthcare Americas Corp Informatics Division II Sep-06-2018
18 Invivo Corporation II Nov-14-2018
19 McKesson Israel Ltd. II Aug-31-2018
20 McKesson Israel Ltd. II Jan-05-2015
21 Merge Healthcare, Inc. II Jan-14-2018
22 Merge Healthcare, Inc. II Jul-10-2017
23 Merge Healthcare, Inc. II Jun-29-2017
24 Merge Healthcare, Inc. II May-02-2017
25 Merge Healthcare, Inc. II Apr-11-2017
26 Merge Healthcare, Inc. II Mar-14-2017
27 Merge Healthcare, Inc. II Feb-15-2017
28 Merge Healthcare, Inc. II Jan-24-2017
29 Merge Healthcare, Inc. II Nov-28-2016
30 Merge Healthcare, Inc. II Aug-04-2016
31 Merge Healthcare, Inc. II Dec-28-2015
32 Merge Healthcare, Inc. II Aug-06-2015
33 Philips Electronics North America Corporation II Dec-14-2018
34 Siemens Medical Solutions USA, Inc II Aug-28-2020
35 Siemens Medical Solutions USA, Inc II Feb-23-2019
36 Siemens Medical Solutions USA, Inc II Jul-06-2017
37 Siemens Medical Solutions USA, Inc II May-24-2017
38 Spacelabs Healthcare, Inc. II Jul-22-2019
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