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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 6
ALIVECOR, INC.
  SUBSTANTIALLY EQUIVALENT 2
ANUMANA, INC
  SUBSTANTIALLY EQUIVALENT 1
B-SECUR LIMITED
  SUBSTANTIALLY EQUIVALENT 1
BIOSENSE WEBSTER, INC.
  SUBSTANTIALLY EQUIVALENT 5
BOSTON SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 5
CARDIOCALM SRL
  SUBSTANTIALLY EQUIVALENT 1
CARDIONXT, INC.
  SUBSTANTIALLY EQUIVALENT 1
CATHETER PRECISION, INC.
  SUBSTANTIALLY EQUIVALENT 1
CATHVISION APS
  SUBSTANTIALLY EQUIVALENT 2
CENTERLINE BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
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 6
EDWARDS LIFESIENCES, LLC
  SUBSTANTIALLY EQUIVALENT 1
GE HEALTHCARE INFORMATION TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 3
IMPLICITY, INC.
  SUBSTANTIALLY EQUIVALENT 1
IRHYTHM TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 3
ITAMAR MEDICAL, LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDICALGORITHMICS S.A.
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 4
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
SIEMENS MEDICAL SOLUTIONS USA INC.
  SUBSTANTIALLY EQUIVALENT 1
SMART SOLUTIONS TECHNOLOGIES SL
  SUBSTANTIALLY EQUIVALENT 1
SPACELABS HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 1
VEKTOR MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
VOLTA MEDICAL
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2020 215 215
2021 351 351
2022 319 319
2023 342 342
2024 565 565

Device Problems MDRs with this Device Problem Events in those MDRs
Display or Visual Feedback Problem 336 336
Communication or Transmission Problem 316 316
Failure to Transmit Record 121 121
Signal Artifact/Noise 112 112
Incorrect, Inadequate or Imprecise Result or Readings 104 104
Incorrect Measurement 100 100
Output Problem 70 70
Application Program Problem 65 65
Failure of Device to Self-Test 50 50
Computer Software Problem 40 40
Failure to Power Up 36 36
Unexpected Shutdown 35 35
Pacing Problem 32 32
Image Orientation Incorrect 29 29
Computer Operating System Problem 28 28
Patient Device Interaction Problem 28 28
No Display/Image 25 25
Inaccurate Information 25 25
Adverse Event Without Identified Device or Use Problem 24 24
No Apparent Adverse Event 24 24
Poor Quality Image 24 24
Smoking 22 22
Improper or Incorrect Procedure or Method 21 21
Appropriate Term/Code Not Available 20 20
Electromagnetic Interference 18 18
Electrical /Electronic Property Problem 18 18
Material Integrity Problem 18 18
Impedance Problem 17 17
Application Program Version or Upgrade Problem 16 16
Use of Device Problem 16 16
Device Emits Odor 16 16
Erratic or Intermittent Display 16 16
No Device Output 16 16
Connection Problem 15 15
Power Problem 15 15
Thermal Decomposition of Device 14 14
Patient Data Problem 14 14
Device Displays Incorrect Message 14 14
Material Twisted/Bent 13 13
Defective Device 13 13
Loose or Intermittent Connection 13 13
Data Problem 12 12
Sparking 12 12
Electrical Shorting 10 10
Noise, Audible 9 9
Fire 8 8
Insufficient Information 8 8
Fitting Problem 7 7
Contamination 7 7
No Pacing 7 7

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1359 1359
No Consequences Or Impact To Patient 155 155
Unspecified Heart Problem 137 137
Insufficient Information 41 41
No Known Impact Or Consequence To Patient 31 31
Cardiac Perforation 20 20
Arrhythmia 14 14
Cardiac Arrest 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Skin Tears 5 5
No Patient Involvement 5 5
Pericardial Effusion 5 5
Heart Block 4 4
Stroke/CVA 4 4
Shock 4 4
Asystole 4 4
Atrial Fibrillation 4 4
Atrial Flutter 2 2
Partial thickness (Second Degree) Burn 2 2
Tachycardia 2 2
Reaction 2 2
Rash 2 2
Skin Inflammation/ Irritation 2 2
No Information 2 2
Electric Shock 2 2
Complaint, Ill-Defined 2 2
Itching Sensation 1 1
Perforation 1 1
Cardiac Tamponade 1 1
Diminished Pulse Pressure 1 1
Vascular Dissection 1 1
Needle Stick/Puncture 1 1
Ventricular Fibrillation 1 1
Dizziness 1 1
Nerve Damage 1 1
Chest Pain 1 1
Nausea 1 1
Failure of Implant 1 1
Hypersensitivity/Allergic reaction 1 1
Anaphylactic Shock 1 1
Unspecified Tissue Injury 1 1
Stenosis 1 1
Death 1 1
Air Embolism 1 1
Syncope/Fainting 1 1
Hemorrhage/Bleeding 1 1
Low Blood Pressure/ Hypotension 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 Edwards Lifesciences, LLC II May-08-2020
11 GE Healthcare, LLC II Apr-13-2022
12 GE Healthcare, LLC II Jun-22-2021
13 GE Medical Systems Information Technologies Inc II Jul-03-2024
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 Jul-25-2024
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 Spacelabs Healthcare, Ltd. II Dec-10-2020
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