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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 8
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
B-SECUR LIMITED
  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 7
CARDIOCALM SRL
  SUBSTANTIALLY EQUIVALENT 1
CARDIONXT, INC.
  SUBSTANTIALLY EQUIVALENT 1
CATHETER PRECISION, INC.
  SUBSTANTIALLY EQUIVALENT 2
CATHVISION APS
  SUBSTANTIALLY EQUIVALENT 2
CENTERLINE BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 4
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 2
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 AI LTD
  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 342 342
2024 451 451

Device Problems MDRs with this Device Problem Events in those MDRs
Communication or Transmission Problem 338 338
Display or Visual Feedback Problem 320 320
Failure to Transmit Record 122 122
Incorrect, Inadequate or Imprecise Result or Readings 117 117
Incorrect Measurement 116 116
Signal Artifact/Noise 112 112
Output Problem 85 85
Application Program Problem 63 63
Failure of Device to Self-Test 60 60
Image Orientation Incorrect 53 53
Failure to Power Up 42 42
Pacing Problem 40 40
Computer Software Problem 40 40
Unexpected Shutdown 35 35
No Display/Image 34 34
Adverse Event Without Identified Device or Use Problem 31 31
Use of Device Problem 28 28
Computer Operating System Problem 28 28
Smoking 27 27
Appropriate Term/Code Not Available 27 27
Patient Device Interaction Problem 25 25
Inaccurate Information 25 25
Poor Quality Image 23 23
Erratic or Intermittent Display 21 21
Sparking 20 20
Electromagnetic Interference 18 18
Impedance Problem 17 17
Electrical /Electronic Property Problem 17 17
Material Integrity Problem 16 16
Application Program Version or Upgrade Problem 16 16
Device Emits Odor 15 15
Power Problem 15 15
Device Displays Incorrect Message 15 15
Thermal Decomposition of Device 14 14
Patient Data Problem 14 14
Data Problem 13 13
Loose or Intermittent Connection 13 13
No Device Output 13 13
No Apparent Adverse Event 12 12
Defective Device 12 12
Material Twisted/Bent 12 12
Failure to Analyze Signal 11 11
Connection Problem 10 10
Electrical Shorting 9 9
Fire 9 9
Noise, Audible 9 9
Insufficient Information 8 8
Overheating of Device 8 8
Application Program Freezes, Becomes Nonfunctional 7 7
No Pacing 7 7

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1256 1256
No Consequences Or Impact To Patient 329 329
Unspecified Heart Problem 137 137
No Known Impact Or Consequence To Patient 77 77
Insufficient Information 39 39
Cardiac Perforation 21 21
Arrhythmia 13 13
Death 7 7
Skin Tears 7 7
No Patient Involvement 7 7
Atrial Fibrillation 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Pericardial Effusion 5 5
Cardiac Arrest 5 5
Stroke/CVA 4 4
Shock 4 4
Heart Block 3 3
Ventricular Fibrillation 3 3
Asystole 3 3
Low Blood Pressure/ Hypotension 2 2
Complaint, Ill-Defined 2 2
Electric Shock 2 2
No Information 2 2
Rash 2 2
Reaction 2 2
Atrial Flutter 1 1
Hemorrhage/Bleeding 1 1
Partial thickness (Second Degree) Burn 1 1
Unspecified Tissue Injury 1 1
Stenosis 1 1
Tachycardia 1 1
Anaphylactic Shock 1 1
Nerve Damage 1 1
Needle Stick/Puncture 1 1
Burn(s) 1 1
Cardiac Tamponade 1 1
Itching Sensation 1 1
Diminished Pulse Pressure 1 1
Perforation 1 1
Skin Inflammation/ Irritation 1 1
Test Result 1 1
Dizziness 1 1
Ventricular Tachycardia 1 1
Nausea 1 1
Failure of Implant 1 1
Syncope/Fainting 1 1
High Blood Pressure/ Hypertension 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 Oct-16-2024
6 Boston Scientific Corporation II Apr-27-2020
7 CHANGE HEALTHCARE CANADA COMPANY II Oct-17-2024
8 CHANGE HEALTHCARE CANADA COMPANY II Apr-08-2020
9 CardioTek BV II Jun-23-2022
10 Change Healthcare Israel Ltd. II May-24-2019
11 Edwards Lifesciences, LLC II May-08-2020
12 GE Healthcare, LLC II Apr-13-2022
13 GE Healthcare, LLC II Jun-22-2021
14 GE Healthcare, LLC II Oct-31-2019
15 GE Healthcare, LLC II Jul-23-2019
16 GE Medical Systems Information Technologies Inc II Jul-03-2024
17 GE Medical Systems Information Technologies Inc II Sep-19-2023
18 Merge Healthcare, Inc. II Aug-28-2021
19 Siemens Medical Solutions USA, Inc II Jul-25-2024
20 Siemens Medical Solutions USA, Inc II Jan-09-2024
21 Siemens Medical Solutions USA, Inc II Jan-01-2023
22 Siemens Medical Solutions USA, Inc III Aug-18-2022
23 Siemens Medical Solutions USA, Inc II Jul-20-2022
24 Siemens Medical Solutions USA, Inc II Jun-06-2022
25 Siemens Medical Solutions USA, Inc II Jan-14-2022
26 Siemens Medical Solutions USA, Inc II Apr-19-2021
27 Siemens Medical Solutions USA, Inc II Mar-04-2021
28 Siemens Medical Solutions USA, Inc II Aug-28-2020
29 Siemens Medical Solutions USA, Inc II Feb-23-2019
30 Spacelabs Healthcare, Inc. II Jul-22-2019
31 Spacelabs Healthcare, Ltd. II Dec-10-2020
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