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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
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
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 138 138

Device Problems MDRs with this Device Problem Events in those MDRs
Communication or Transmission Problem 296 296
Display or Visual Feedback Problem 276 276
Incorrect Measurement 101 101
Failure to Transmit Record 94 94
Signal Artifact/Noise 91 91
Incorrect, Inadequate or Imprecise Result or Readings 84 84
Output Problem 79 79
Failure of Device to Self-Test 55 55
Image Orientation Incorrect 53 53
Application Program Problem 49 49
Failure to Power Up 39 39
Pacing Problem 37 37
No Display/Image 34 34
Unexpected Shutdown 33 33
Adverse Event Without Identified Device or Use Problem 28 28
Use of Device Problem 27 27
Computer Software Problem 26 26
Appropriate Term/Code Not Available 25 25
Smoking 24 24
Patient Device Interaction Problem 23 23
Computer Operating System Problem 21 21
Erratic or Intermittent Display 21 21
Poor Quality Image 18 18
Sparking 18 18
Impedance Problem 17 17
Electromagnetic Interference 17 17
Application Program Version or Upgrade Problem 15 15
Inaccurate Information 15 15
Patient Data Problem 14 14
Power Problem 13 13
Device Displays Incorrect Message 13 13
Material Integrity Problem 13 13
Electrical /Electronic Property Problem 13 13
Device Emits Odor 13 13
No Device Output 13 13
Loose or Intermittent Connection 12 12
Thermal Decomposition of Device 12 12
Material Twisted/Bent 12 12
Data Problem 11 11
Defective Device 11 11
Failure to Analyze Signal 11 11
Fire 9 9
Connection Problem 7 7
No Pacing 7 7
Insufficient Information 7 7
Noise, Audible 7 7
Electrical Shorting 7 7
Application Program Freezes, Becomes Nonfunctional 7 7
Operating System Version or Upgrade Problem 6 6
Fitting Problem 6 6
Mechanical Problem 6 6
Overheating of Device 5 5
Loss of Threshold 5 5
Loss of Power 5 5
Device Remains Activated 4 4
Activation, Positioning or Separation Problem 4 4
Unintended Application Program Shut Down 4 4
No Visual Prompts/Feedback 4 4
Unintended Electrical Shock 4 4
Environmental Compatibility Problem 3 3
Device Sensing Problem 3 3
Material Deformation 3 3
Inadequate User Interface 3 3
Failure to Auto Stop 3 3
Operating System Becomes Nonfunctional 3 3
Therapeutic or Diagnostic Output Failure 3 3
Improper or Incorrect Procedure or Method 3 3
Power Conditioning Problem 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
Battery Problem 2 2
Contamination /Decontamination Problem 2 2
Self-Activation or Keying 2 2
No Apparent Adverse Event 2 2
Activation Failure 2 2
Detachment of Device or Device Component 2 2
Application Network Problem 2 2
No Tactile Prompts/Feedback 2 2
Intermittent Communication Failure 2 2
Fail-Safe Did Not Operate 1 1
Radiation Output Problem 1 1
Radiation Output Failure 1 1
Tactile Prompts/Feedback 1 1
Intermittent Loss of Power 1 1
Program or Algorithm Execution Problem 1 1
Program or Algorithm Execution Failure 1 1
Device Markings/Labelling Problem 1 1
Device-Device Incompatibility 1 1
Electrical Overstress 1 1
Device Contamination with Chemical or Other Material 1 1
Device Contaminated During Manufacture or Shipping 1 1
Device Handling Problem 1 1
Protective Measures Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1030 1030
No Consequences Or Impact To Patient 329 329
Unspecified Heart Problem 98 98
No Known Impact Or Consequence To Patient 77 77
Insufficient Information 34 34
Cardiac Perforation 19 19
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
Ventricular Fibrillation 3 3
Heart Block 3 3
Asystole 2 2
No Information 2 2
Pericardial Effusion 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
Test Result 1 1
Syncope/Fainting 1 1
Ventricular Tachycardia 1 1
Cardiac Tamponade 1 1
Electric Shock 1 1
Diminished Pulse Pressure 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 Sep-19-2023
15 Merge Healthcare, Inc. II Aug-28-2021
16 Siemens Medical Solutions USA, Inc II Jan-09-2024
17 Siemens Medical Solutions USA, Inc II Jan-01-2023
18 Siemens Medical Solutions USA, Inc III Aug-18-2022
19 Siemens Medical Solutions USA, Inc II Jul-20-2022
20 Siemens Medical Solutions USA, Inc II Jun-06-2022
21 Siemens Medical Solutions USA, Inc II Jan-14-2022
22 Siemens Medical Solutions USA, Inc II Apr-19-2021
23 Siemens Medical Solutions USA, Inc II Mar-04-2021
24 Siemens Medical Solutions USA, Inc II Aug-28-2020
25 Siemens Medical Solutions USA, Inc II Feb-23-2019
26 Spacelabs Healthcare, Inc. II Jul-22-2019
27 Spacelabs Healthcare, Ltd. II Dec-10-2020
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