Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device computer, diagnostic, programmable
Product CodeDQK
Regulation Number 870.1425
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 5
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 9
ALIVECOR, INC.
  SUBSTANTIALLY EQUIVALENT 3
BIOFOURMIS SINGAPORE PTE. LTD.
  SUBSTANTIALLY EQUIVALENT 1
BIOSENSE WEBSTER, INC.
  SUBSTANTIALLY EQUIVALENT 9
BIOSIG TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 6
CARDIOCALM SRL
  SUBSTANTIALLY EQUIVALENT 1
CARDIONXT, INC.
  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
EDWARDS LFESCIENCES
  SUBSTANTIALLY EQUIVALENT 1
EDWARDS LIFECIENCES, LLC
  SUBSTANTIALLY EQUIVALENT 1
EDWARDS LIFESCIENCES LLC
  SUBSTANTIALLY EQUIVALENT 1
EDWARDS LIFESCIENCES, LLC
  SUBSTANTIALLY EQUIVALENT 8
EDWARDS LIFESIENCES, LLC
  SUBSTANTIALLY EQUIVALENT 1
EPIPHANY HEALTHCARE, LLC
  SUBSTANTIALLY EQUIVALENT 1
GE HEALTHCARE INFORMATION TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
IMPLICITY, INC.
  SUBSTANTIALLY EQUIVALENT 1
IRHYTHM TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 5
ITAMAR MEDICAL, LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDICALGORITHMICS S.A.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEM NEDERLAND B.V.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
  SUBSTANTIALLY EQUIVALENT 2
PHILIPS MEDICAL SYSTEMS NEDERLAND, B.V. (PMSN)
  SUBSTANTIALLY EQUIVALENT 1
QUIPU S.R.L
  SUBSTANTIALLY EQUIVALENT 1
RHYTHM AL, LTD
  SUBSTANTIALLY EQUIVALENT 1
SCHWARZER CARDIOTEK GMBH
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN CAREWELL ELECTRONICS., LTD
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS MEDICAL SOLUTIONS USA INC.
  SUBSTANTIALLY EQUIVALENT 1
SMART SOLUTIONS TECHNOLOGIES SL
  SUBSTANTIALLY EQUIVALENT 1
SPACELABS HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 1
ST. JUDE MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ST. JUDE MEDICAL (NOW ABBOTT MEDICAL)
  SUBSTANTIALLY EQUIVALENT 1
VEKTOR MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
VOLTA MEDICAL
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2018 261 261
2019 218 218
2020 215 215
2021 351 351
2022 319 319
2023 219 219

Device Problems MDRs with this Device Problem Events in those MDRs
Communication or Transmission Problem 301 301
Display or Visual Feedback Problem 239 239
Incorrect Measurement 102 102
Signal Artifact/Noise 84 84
Image Orientation Incorrect 81 81
Incorrect, Inadequate or Imprecise Result or Readings 81 81
Output Problem 76 76
Failure of Device to Self-Test 50 50
Failure to Power Up 47 47
Application Program Problem 47 47
No Display/Image 43 43
Adverse Event Without Identified Device or Use Problem 35 35
Unexpected Shutdown 34 34
Computer Software Problem 34 34
Retraction Problem 31 31
Smoking 30 30
Pacing Problem 29 29
Appropriate Term/Code Not Available 27 27
Use of Device Problem 26 26
Erratic or Intermittent Display 24 24
Device Displays Incorrect Message 23 23
Patient Device Interaction Problem 22 22
Computer Operating System Problem 20 20
Sparking 19 19
Impedance Problem 15 15
Electromagnetic Interference 15 15
No Device Output 14 14
Application Program Version or Upgrade Problem 14 14
Patient Data Problem 14 14
Application Program Freezes, Becomes Nonfunctional 13 13
Power Problem 13 13
Poor Quality Image 13 13
Loose or Intermittent Connection 12 12
Thermal Decomposition of Device 12 12
Material Twisted/Bent 12 12
Data Problem 11 11
Noise, Audible 11 11
Electrical /Electronic Property Problem 11 11
Device Emits Odor 11 11
Failure to Analyze Signal 11 11
Fire 10 10
Insufficient Information 10 10
No Pacing 9 9
Defective Device 9 9
Failure to Transmit Record 8 8
Material Integrity Problem 8 8
Connection Problem 8 8
Improper Device Output 7 7
Intermittent Communication Failure 7 7
Operating System Version or Upgrade Problem 6 6
Device Operational Issue 6 6
Device Issue 6 6
Mechanical Problem 6 6
Overheating of Device 6 6
Loss of Threshold 5 5
Loss of Power 5 5
Electrical Shorting 5 5
Device Operates Differently Than Expected 4 4
Activation, Positioning or Separation Problem 4 4
Operating System Becomes Nonfunctional 4 4
Unintended Application Program Shut Down 4 4
Unintended Electrical Shock 4 4
Device Remains Activated 4 4
Fitting Problem 4 4
Improper or Incorrect Procedure or Method 3 3
Low Readings 3 3
Failure to Read Input Signal 3 3
Power Conditioning Problem 3 3
Failure to Deliver Energy 3 3
Application Interface Becomes Non-Functional Or Program Exits Abnormally 3 3
Break 3 3
No Visual Prompts/Feedback 3 3
Therapeutic or Diagnostic Output Failure 3 3
Inadequate User Interface 3 3
Material Deformation 3 3
Detachment of Device or Device Component 3 3
Environmental Compatibility Problem 3 3
Device Sensing Problem 3 3
Contamination /Decontamination Problem 2 2
Application Network Problem 2 2
Failure to Auto Stop 2 2
No Apparent Adverse Event 2 2
No Tactile Prompts/Feedback 2 2
Activation Failure 2 2
Temperature Problem 2 2
Use of Incorrect Control/Treatment Settings 2 2
Melted 2 2
Unintended System Motion 2 2
Fracture 2 2
High impedance 2 2
Inappropriate/Inadequate Shock/Stimulation 2 2
Self-Activation or Keying 2 2
Failure to Disconnect 2 2
Arcing 2 2
Battery Problem 2 2
High Test Results 2 2
High Readings 2 2
Tear, Rip or Hole in Device Packaging 1 1
Visual Prompts will not Clear 1 1
Defective Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 849 849
No Consequences Or Impact To Patient 522 522
No Known Impact Or Consequence To Patient 126 126
Insufficient Information 33 33
Cardiac Perforation 18 18
No Patient Involvement 16 16
Death 9 9
Cardiac Arrest 7 7
Arrhythmia 7 7
Skin Tears 7 7
No Information 5 5
Atrial Fibrillation 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Shock 4 4
Stroke/CVA 3 3
Ventricular Fibrillation 3 3
Electric Shock 3 3
Cardiac Tamponade 3 3
Heart Block 3 3
Asystole 2 2
Complaint, Ill-Defined 2 2
Reaction 2 2
Sudden Cardiac Death 2 2
Complete Heart Block 2 2
Partial thickness (Second Degree) Burn 2 2
Rash 2 2
Low Blood Pressure/ Hypotension 2 2
Failure of Implant 1 1
Itching Sensation 1 1
Nerve Damage 1 1
Anaphylactic Shock 1 1
Tachycardia 1 1
Hemorrhage/Bleeding 1 1
High Blood Pressure/ Hypertension 1 1
Atrial Flutter 1 1
Burn(s) 1 1
Test Result 1 1
Pericardial Effusion 1 1
Syncope/Fainting 1 1
Ventricular Tachycardia 1 1
Needle Stick/Puncture 1 1
Diminished Pulse Pressure 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-23-2022
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 Apr-13-2022
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 Sep-19-2023
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 Merge Healthcare, Inc. II Aug-28-2021
21 Merge Healthcare, Inc. II Jan-14-2018
22 Philips Electronics North America Corporation II Dec-14-2018
23 Siemens Medical Solutions USA, Inc II Jan-01-2023
24 Siemens Medical Solutions USA, Inc III Aug-18-2022
25 Siemens Medical Solutions USA, Inc II Jul-20-2022
26 Siemens Medical Solutions USA, Inc II Jun-06-2022
27 Siemens Medical Solutions USA, Inc II Jan-14-2022
28 Siemens Medical Solutions USA, Inc II Apr-19-2021
29 Siemens Medical Solutions USA, Inc II Mar-04-2021
30 Siemens Medical Solutions USA, Inc II Aug-28-2020
31 Siemens Medical Solutions USA, Inc II Feb-23-2019
32 Spacelabs Healthcare, Inc. II Jul-22-2019
33 Spacelabs Healthcare, Ltd. II Dec-10-2020
-
-