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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 ELECTROPHYSIOLOGY
  SUBSTANTIALLY EQUIVALENT 1
ABBOTT MEDICAL
  SUBSTANTIALLY EQUIVALENT 4
ABLACON, INC.
  SUBSTANTIALLY EQUIVALENT 1
ACUTUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 8
ALIVECOR, INC.
  SUBSTANTIALLY EQUIVALENT 2
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 7
CARDIONXT, INC.
  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
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 1
GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG
  SUBSTANTIALLY EQUIVALENT 1
IMPLICITY, INC.
  SUBSTANTIALLY EQUIVALENT 1
IRHYTHM TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 3
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEM NEDERLAND B.V.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
  SUBSTANTIALLY EQUIVALENT 1
QUIPU S.R.L
  SUBSTANTIALLY EQUIVALENT 1
SCHWARZER CARDIOTEK GMBH
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN CAREWELL ELECTRONICS., LTD
  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 1

MDR Year MDR Reports MDR Events
2017 252 252
2018 261 261
2019 218 218
2020 215 215
2021 350 350

Device Problems MDRs with this Device Problem Events in those MDRs
Communication or Transmission Problem 208 208
Display or Visual Feedback Problem 109 109
Image Orientation Incorrect 81 81
Incorrect Measurement 81 81
Incorrect, Inadequate or Imprecise Resultor Readings 63 63
No Display/Image 52 52
Output Problem 48 48
Failure to Power Up 45 45
Adverse Event Without Identified Device or Use Problem 42 42
Signal Artifact/Noise 40 40
Device Issue 38 38
Failure to Transmit Record 37 37
Failure of Device to Self-Test 37 37
Application Program Problem 34 34
Application Interface Becomes Non-Functional Or Program Exits Abnormally 34 34
Data Problem 33 33
Device Displays Incorrect Message 32 32
Computer Software Problem 32 32
Retraction Problem 31 31
Smoking 25 25
Pacing Problem 22 22
Unexpected Shutdown 22 22
Device Operates Differently Than Expected 21 21
Use of Device Problem 21 21
Appropriate Term/Code Not Available 20 20
Erratic or Intermittent Display 18 18
Power Problem 17 17
Sparking 17 17
Application Program Version or Upgrade Problem 16 16
Insufficient Information 16 16
Noise, Audible 15 15
Patient Data Problem 14 14
Improper Device Output 13 13
No Device Output 13 13
Computer Operating System Problem 12 12
Application Program Freezes, Becomes Nonfunctional 12 12
Device Operational Issue 11 11
Failure to Analyze Signal 11 11
Connection Problem 9 9
Battery Problem 9 9
Patient Device Interaction Problem 9 9
Impedance Problem 8 8
Thermal Decomposition of Device 8 8
Electrical /Electronic Property Problem 7 7
Overheating of Device 7 7
Difficult to Remove 7 7
No Pacing 7 7
Intermittent Communication Failure 7 7
Material Twisted/Bent 6 6
Fire 6 6
Poor Quality Image 6 6
Device Emits Odor 6 6
Loose or Intermittent Connection 5 5
Loss of Threshold 5 5
Loss of Power 5 5
Material Integrity Problem 5 5
Blocked Connection 5 5
Failure to Read Input Signal 4 4
Application Network Problem 4 4
No Apparent Adverse Event 4 4
Unintended Application Program Shut Down 4 4
Device Remains Activated 4 4
Electromagnetic Interference 4 4
Bent 3 3
Break 3 3
Device Alarm System 3 3
Image Display Error/Artifact 3 3
Mechanical Problem 3 3
Failure to Deliver Energy 3 3
Self-Activation or Keying 3 3
Power Conditioning Problem 3 3
Improper or Incorrect Procedure or Method 3 3
Therapeutic or Diagnostic Output Failure 3 3
Environmental Compatibility Problem 3 3
Detachment of Device or Device Component 3 3
Device Sensing Problem 3 3
Electrical Shorting 3 3
Material Deformation 3 3
Inadequate User Interface 3 3
Defective Device 3 3
High Readings 3 3
Loss of Data 2 2
No Fail-Safe Mechanism 2 2
Operating System Becomes Nonfunctional 2 2
Temperature Problem 2 2
No Visual Prompts/Feedback 2 2
Failure to Zero 2 2
High Test Results 2 2
Fitting Problem 2 2
Device Inoperable 2 2
Inappropriate/Inadequate Shock/Stimulation 2 2
Product Quality Problem 2 2
Over-Sensing 2 2
Fracture 2 2
Use of Incorrect Control Settings 2 2
Failure to Cycle 2 2
Decoupling 1 1
Disconnection 1 1
Contamination 1 1
Intermittent Continuity 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 608 608
No Clinical Signs, Symptoms or Conditions 347 347
No Known Impact Or Consequence To Patient 256 256
No Patient Involvement 25 25
Insufficient Information 22 22
Cardiac Perforation 15 15
Death 13 13
Tissue Damage 7 7
Ventricular Fibrillation 6 6
Cardiac Arrest 6 6
Skin Tears 5 5
No Information 5 5
Cardiac Tamponade 5 5
Arrhythmia 4 4
Atrial Fibrillation 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Sudden Cardiac Death 3 3
Partial thickness (Second Degree) Burn 3 3
Electric Shock 3 3
Complete Heart Block 3 3
Burn(s) 3 3
Low Blood Pressure/ Hypotension 2 2
Inflammation 2 2
Complaint, Ill-Defined 2 2
Ventricular Tachycardia 2 2
Rash 2 2
Reaction 2 2
Heart Block 2 2
Test Result 1 1
Asystole 1 1
Patient Problem/Medical Problem 1 1
Scarring 1 1
Sepsis 1 1
Impaired Healing 1 1
Cardiogenic Shock 1 1
Itching Sensation 1 1
Pain 1 1
Antibiotics, Reaction To 1 1
Bradycardia 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 Boston Scientific Corporation II Apr-27-2020
4 CHANGE HEALTHCARE CANADA COMPANY II Apr-08-2020
5 CardioTek BV II Jun-30-2017
6 Change Healthcare Israel Ltd. II May-24-2019
7 Edwards Lifesciences, LLC II May-08-2020
8 Edwards Lifesciences, LLC II Jan-16-2018
9 GE Healthcare Finland Oy II Oct-10-2018
10 GE Healthcare Finland Oy II Jul-02-2018
11 GE Healthcare, LLC II Jun-22-2021
12 GE Healthcare, LLC II Oct-31-2019
13 GE Healthcare, LLC II Jul-23-2019
14 GE Medical Systems Information Technologies, Inc. II Jan-25-2018
15 Hitachi Healthcare Americas Corp Informatics Division II Sep-06-2018
16 Invivo Corporation II Nov-14-2018
17 McKesson Israel Ltd. II Aug-31-2018
18 Merge Healthcare, Inc. II Aug-28-2021
19 Merge Healthcare, Inc. II Jan-14-2018
20 Merge Healthcare, Inc. II Jul-10-2017
21 Merge Healthcare, Inc. II Jun-29-2017
22 Merge Healthcare, Inc. II May-02-2017
23 Merge Healthcare, Inc. II Apr-11-2017
24 Merge Healthcare, Inc. II Mar-14-2017
25 Merge Healthcare, Inc. II Feb-15-2017
26 Merge Healthcare, Inc. II Jan-24-2017
27 Philips Electronics North America Corporation II Dec-14-2018
28 Siemens Medical Solutions USA, Inc II Jan-14-2022
29 Siemens Medical Solutions USA, Inc II Apr-19-2021
30 Siemens Medical Solutions USA, Inc II Mar-04-2021
31 Siemens Medical Solutions USA, Inc II Aug-28-2020
32 Siemens Medical Solutions USA, Inc II Feb-23-2019
33 Siemens Medical Solutions USA, Inc II Jul-06-2017
34 Siemens Medical Solutions USA, Inc II May-24-2017
35 Spacelabs Healthcare, Inc. II Jul-22-2019
36 Spacelabs Healthcare, Ltd. II Dec-10-2020
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