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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
Regulation Description Programmable diagnostic computer.
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 2
CARDIONXT, INC.
  SUBSTANTIALLY EQUIVALENT 1
CATHETER PRECISION, INC.
  SUBSTANTIALLY EQUIVALENT 1
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 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
VITALCONNECT, 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 564 564
2025 145 145

Device Problems MDRs with this Device Problem Events in those MDRs
Display or Visual Feedback Problem 349 349
Communication or Transmission Problem 336 336
Signal Artifact/Noise 121 121
Failure to Transmit Record 121 121
Incorrect, Inadequate or Imprecise Result or Readings 115 115
Incorrect Measurement 107 107
Output Problem 74 74
Application Program Problem 69 69
Failure of Device to Self-Test 53 53
Computer Software Problem 42 42
Pacing Problem 37 37
Failure to Power Up 36 36
Unexpected Shutdown 35 35
Computer Operating System Problem 30 30
Patient Device Interaction Problem 29 29
Image Orientation Incorrect 29 29
Adverse Event Without Identified Device or Use Problem 27 27
Poor Quality Image 26 26
No Display/Image 26 26
Inaccurate Information 25 25
No Apparent Adverse Event 24 24
Smoking 22 22
Appropriate Term/Code Not Available 21 21
Improper or Incorrect Procedure or Method 21 21
Electromagnetic Interference 19 19
Connection Problem 19 19
Electrical /Electronic Property Problem 19 19
Material Integrity Problem 18 18
Impedance Problem 18 18
Device Emits Odor 17 17
Device Displays Incorrect Message 17 17
Use of Device Problem 17 17
Power Problem 16 16
Erratic or Intermittent Display 16 16
Application Program Version or Upgrade Problem 16 16
Thermal Decomposition of Device 16 16
No Device Output 16 16
Electrical Shorting 14 14
Loose or Intermittent Connection 14 14
Patient Data Problem 14 14
Defective Device 13 13
Material Twisted/Bent 13 13
Data Problem 12 12
Sparking 12 12
Noise, Audible 10 10
Mechanical Problem 9 9
Overheating of Device 9 9
Fitting Problem 8 8
Fire 8 8
Insufficient Information 8 8

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1488 1488
No Consequences Or Impact To Patient 155 155
Unspecified Heart Problem 137 137
Insufficient Information 44 44
No Known Impact Or Consequence To Patient 31 31
Arrhythmia 21 21
Cardiac Perforation 20 20
Cardiac Arrest 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Stroke/CVA 5 5
Skin Tears 5 5
No Patient Involvement 5 5
Pericardial Effusion 5 5
Heart Block 4 4
Shock 4 4
Asystole 4 4
Atrial Fibrillation 4 4
Electric Shock 3 3
Atrial Flutter 2 2
Partial thickness (Second Degree) Burn 2 2
Tachycardia 2 2
Reaction 2 2
Bradycardia 2 2
Rash 2 2
Diminished Pulse Pressure 2 2
Skin Inflammation/ Irritation 2 2
No Information 2 2
Complaint, Ill-Defined 2 2
Air Embolism 2 2
Cardiac Tamponade 1 1
Itching Sensation 1 1
Perforation 1 1
Ventricular Fibrillation 1 1
Needle Stick/Puncture 1 1
Vascular Dissection 1 1
Chest Pain 1 1
Nerve Damage 1 1
Dizziness 1 1
Nausea 1 1
Failure of Implant 1 1
Anaphylactic Shock 1 1
Stenosis 1 1
Unspecified Tissue Injury 1 1
Hypersensitivity/Allergic reaction 1 1
Death 1 1
Syncope/Fainting 1 1
High Blood Pressure/ Hypertension 1 1
Hemorrhage/Bleeding 1 1
Low Blood Pressure/ Hypotension 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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