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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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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 3
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
ANUMANA, INC
  SUBSTANTIALLY EQUIVALENT 1
BIOFOURMIS SINGAPORE PTE. LTD.
  SUBSTANTIALLY EQUIVALENT 1
BIOSENSE WEBSTER, INC.
  SUBSTANTIALLY EQUIVALENT 6
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
GE HEALTHCARE INFORMATION TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
IMPLICITY, INC.
  SUBSTANTIALLY EQUIVALENT 1
IRHYTHM TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 4
ITAMAR MEDICAL, LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDICALGORITHMICS S.A.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
MERGE HEALTHCARE INCORPORATED
  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
SIEMENS MEDICAL SOLUTIONS USA INC.
  SUBSTANTIALLY EQUIVALENT 1
SMART SOLUTIONS TECHNOLOGIES SL
  SUBSTANTIALLY EQUIVALENT 1
SPACELABS HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 1
ST. JUDE MEDICAL (NOW ABBOTT MEDICAL)
  SUBSTANTIALLY EQUIVALENT 1
VEKTOR MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
VOLTA MEDICAL
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2019 218 218
2020 215 215
2021 351 351
2022 319 319
2023 368 368
2024 248 248

Device Problems MDRs with this Device Problem Events in those MDRs
Communication or Transmission Problem 318 318
Display or Visual Feedback Problem 297 297
Incorrect Measurement 106 106
Incorrect, Inadequate or Imprecise Result or Readings 102 102
Signal Artifact/Noise 100 100
Failure to Transmit Record 96 96
Output Problem 80 80
Failure of Device to Self-Test 57 57
Application Program Problem 56 56
Image Orientation Incorrect 53 53
Failure to Power Up 41 41
Pacing Problem 39 39
No Display/Image 34 34
Unexpected Shutdown 34 34
Adverse Event Without Identified Device or Use Problem 28 28
Use of Device Problem 28 28
Computer Software Problem 27 27
Appropriate Term/Code Not Available 26 26
Inaccurate Information 25 25
Patient Device Interaction Problem 24 24
Smoking 24 24
Computer Operating System Problem 23 23
Erratic or Intermittent Display 21 21
Poor Quality Image 19 19
Sparking 19 19
Electromagnetic Interference 18 18
Impedance Problem 17 17
Electrical /Electronic Property Problem 16 16
Application Program Version or Upgrade Problem 15 15
Material Integrity Problem 15 15
Patient Data Problem 14 14
Power Problem 14 14
Device Displays Incorrect Message 14 14
Device Emits Odor 14 14
No Device Output 13 13
Thermal Decomposition of Device 12 12
Loose or Intermittent Connection 12 12
Data Problem 12 12
Material Twisted/Bent 12 12
Failure to Analyze Signal 11 11
Defective Device 11 11
Fire 9 9
Electrical Shorting 9 9
Connection Problem 8 8
Insufficient Information 8 8
Noise, Audible 8 8
No Pacing 7 7
Application Program Freezes, Becomes Nonfunctional 7 7
Mechanical Problem 7 7
Fitting Problem 7 7
Overheating of Device 6 6
Operating System Version or Upgrade Problem 6 6
Unintended Electrical Shock 5 5
Loss of Threshold 5 5
Loss of Power 5 5
Device Remains Activated 4 4
No Visual Prompts/Feedback 4 4
Unintended Application Program Shut Down 4 4
Activation, Positioning or Separation Problem 4 4
Device Sensing Problem 4 4
Detachment of Device or Device Component 3 3
Environmental Compatibility Problem 3 3
Failure to Auto Stop 3 3
Inadequate User Interface 3 3
Operating System Becomes Nonfunctional 3 3
Material Deformation 3 3
Therapeutic or Diagnostic Output Failure 3 3
Power Conditioning Problem 3 3
Improper or Incorrect Procedure or Method 3 3
Tear, Rip or Hole in Device Packaging 3 3
Break 3 3
Failure to Deliver Energy 3 3
Use of Incorrect Control/Treatment Settings 2 2
Unintended System Motion 2 2
High impedance 2 2
High Readings 2 2
Low Readings 2 2
Failure to Disconnect 2 2
Arcing 2 2
Application Network Problem 2 2
Battery Problem 2 2
Contamination /Decontamination Problem 2 2
Self-Activation or Keying 2 2
Material Puncture/Hole 2 2
Unable to Obtain Readings 2 2
No Apparent Adverse Event 2 2
No Tactile Prompts/Feedback 2 2
Intermittent Communication Failure 2 2
Activation Failure 2 2
Intermittent Loss of Power 1 1
Tactile Prompts/Feedback 1 1
Fail-Safe Did Not Operate 1 1
Radiation Output Problem 1 1
Radiation Output Failure 1 1
Program or Algorithm Execution Problem 1 1
Program or Algorithm Execution Failure 1 1
Device Handling Problem 1 1
Output below Specifications 1 1
Protective Measures Problem 1 1
Temperature Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1123 1123
No Consequences Or Impact To Patient 329 329
Unspecified Heart Problem 109 109
No Known Impact Or Consequence To Patient 77 77
Insufficient Information 34 34
Cardiac Perforation 20 20
Arrhythmia 8 8
Death 7 7
Skin Tears 7 7
No Patient Involvement 7 7
Atrial Fibrillation 6 6
Cardiac Arrest 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Shock 4 4
Stroke/CVA 3 3
Pericardial Effusion 3 3
Ventricular Fibrillation 3 3
Heart Block 3 3
Asystole 2 2
Electric Shock 2 2
No Information 2 2
Complaint, Ill-Defined 2 2
Reaction 2 2
Rash 2 2
Low Blood Pressure/ Hypotension 2 2
Failure of Implant 1 1
Itching Sensation 1 1
Nerve Damage 1 1
Perforation 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
Needle Stick/Puncture 1 1
Partial thickness (Second Degree) Burn 1 1
Test Result 1 1
Syncope/Fainting 1 1
Diminished Pulse Pressure 1 1
Ventricular Tachycardia 1 1
Cardiac Tamponade 1 1
Stenosis 1 1
Unspecified Tissue Injury 1 1

Recalls
Manufacturer Recall Class Date Posted
1 APN Health LLC III Dec-14-2023
2 Abbott Laboratories Inc. (St Jude Medical) II Jun-14-2021
3 Baxter Healthcare Corporation II Sep-28-2023
4 Biosense Webster (israel), Ltd. II Aug-24-2020
5 Boston Scientific Corporation II Apr-27-2020
6 CHANGE HEALTHCARE CANADA COMPANY II Apr-08-2020
7 CardioTek BV II Jun-23-2022
8 Change Healthcare Israel Ltd. II May-24-2019
9 Edwards Lifesciences, LLC II May-08-2020
10 GE Healthcare, LLC II Apr-13-2022
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 Jul-03-2024
15 GE Medical Systems Information Technologies Inc II Sep-19-2023
16 Merge Healthcare, Inc. II Aug-28-2021
17 Siemens Medical Solutions USA, Inc II Jan-09-2024
18 Siemens Medical Solutions USA, Inc II Jan-01-2023
19 Siemens Medical Solutions USA, Inc III Aug-18-2022
20 Siemens Medical Solutions USA, Inc II Jul-20-2022
21 Siemens Medical Solutions USA, Inc II Jun-06-2022
22 Siemens Medical Solutions USA, Inc II Jan-14-2022
23 Siemens Medical Solutions USA, Inc II Apr-19-2021
24 Siemens Medical Solutions USA, Inc II Mar-04-2021
25 Siemens Medical Solutions USA, Inc II Aug-28-2020
26 Siemens Medical Solutions USA, Inc II Feb-23-2019
27 Spacelabs Healthcare, Inc. II Jul-22-2019
28 Spacelabs Healthcare, Ltd. II Dec-10-2020
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