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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device electrocardiograph
Product CodeDPS
Regulation Number 870.2340
Device Class 2


Premarket Reviews
ManufacturerDecision
ACCURKARDIA, INC.
  SUBSTANTIALLY EQUIVALENT 1
AMCG CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
B-SECUR LTD.
  SUBSTANTIALLY EQUIVALENT 1
BIOCARE BIO-MEDICAL EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BIONET CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
CAF MEDICAL SOLUTIONS INC.
  SUBSTANTIALLY EQUIVALENT 1
CARDIACSENSE
  SUBSTANTIALLY EQUIVALENT 1
CARDIO-PHOENIX INC.
  SUBSTANTIALLY EQUIVALENT 1
CARDIOLOGS TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
COALA LIFE AB
  SUBSTANTIALLY EQUIVALENT 1
CONTEC MEDICAL SYSTEMS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CORSCIENCE GMBH & CO.
  SUBSTANTIALLY EQUIVALENT 1
DAILYCARE BIOMEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
EDAN INSTRUMENTS, INC
  SUBSTANTIALLY EQUIVALENT 1
EDAN INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 3
EKGENIUS LLC
  SUBSTANTIALLY EQUIVALENT 1
FUKUDA DENSHI USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 3
GENETESIS INC.
  SUBSTANTIALLY EQUIVALENT 1
IMEDRIX INC. (FORMERLY PIITECH INC.)
  SUBSTANTIALLY EQUIVALENT 1
MASIMO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL PREDICTIVE SCIENCE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
MEDIZIN SYSTEME BOBLINGEN GMBH
  SUBSTANTIALLY EQUIVALENT 1
MESI, DEVELOPMENT OF MEDICAL DEVICES, LTD; MESI, D.O.O.
  SUBSTANTIALLY EQUIVALENT 1
MITAC INTERNATIONAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 2
PHYSIQ INC.
  SUBSTANTIALLY EQUIVALENT 1
PHYSIQ, INC
  SUBSTANTIALLY EQUIVALENT 2
SAMSUNG STRATEGY AND INNOVATION CENTER (SSIC)
  SUBSTANTIALLY EQUIVALENT 1
SCHILLER AG
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN CAREWELL ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SUZUKEN CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
TRISMED CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
VECTRACOR, INC.
  SUBSTANTIALLY EQUIVALENT 1
WITHINGS
  SUBSTANTIALLY EQUIVALENT 1
WITHINGS SA
  SUBSTANTIALLY EQUIVALENT 1
ZOLL MANUFACTURING CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 19 19
2019 27 27
2020 59 59
2021 24 24
2022 59 59
2023 54 54
2024 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Wireless Communication Problem 65 65
Intermittent Communication Failure 27 27
Patient Data Problem 20 20
Unable to Obtain Readings 16 16
Fire 16 16
Insufficient Information 8 8
Incorrect, Inadequate or Imprecise Result or Readings 8 8
No Display/Image 7 7
Therapeutic or Diagnostic Output Failure 6 6
Smoking 5 5
Sparking 5 5
Battery Problem 5 5
Data Problem 4 4
Connection Problem 4 4
Computer Operating System Problem 4 4
Application Program Problem 3 3
Detachment of Device or Device Component 3 3
Mechanical Problem 3 3
Break 3 3
Output Problem 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Appropriate Term/Code Not Available 3 3
Incorrect Measurement 3 3
Display Difficult to Read 3 3
Improper or Incorrect Procedure or Method 3 3
Defective Component 2 2
Product Quality Problem 2 2
Use of Device Problem 2 2
Thermal Decomposition of Device 2 2
Disconnection 2 2
Loose or Intermittent Connection 2 2
Operating System Version or Upgrade Problem 2 2
Program or Algorithm Execution Problem 2 2
Device Emits Odor 2 2
Image Display Error/Artifact 2 2
Excessive Heating 2 2
Leak/Splash 1 1
Unexpected Shutdown 1 1
Protective Measures Problem 1 1
Inability to Auto-Fill 1 1
Device Handling Problem 1 1
Failure to Power Up 1 1
Patient Device Interaction Problem 1 1
Material Rupture 1 1
Computer Software Problem 1 1
Device Alarm System 1 1
Device Damaged Prior to Use 1 1
Malposition of Device 1 1
Crack 1 1
Temperature Problem 1 1
Defective Device 1 1
Overheating of Device 1 1
Labelling, Instructions for Use or Training Problem 1 1
Noise, Audible 1 1
No Device Output 1 1
Signal Artifact/Noise 1 1
Capturing Problem 1 1
Self-Activation or Keying 1 1
Inappropriate Waveform 1 1
Application Program Freezes, Becomes Nonfunctional 1 1
Explosion 1 1
Device Difficult to Program or Calibrate 1 1
Electrical /Electronic Property Problem 1 1
Device Displays Incorrect Message 1 1
Compatibility Problem 1 1
Failure to Read Input Signal 1 1
Device Fell 1 1
Device Stops Intermittently 1 1
Power Problem 1 1
Failure to Capture 1 1
Unexpected Therapeutic Results 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Device Operates Differently Than Expected 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 113 113
No Patient Involvement 56 56
No Known Impact Or Consequence To Patient 31 31
Insufficient Information 21 21
No Consequences Or Impact To Patient 9 9
Myocardial Infarction 4 4
Death 4 4
Superficial (First Degree) Burn 4 4
Burn(s) 3 3
Cardiac Arrest 3 3
Electric Shock 3 3
Eye Pain 2 2
Burning Sensation 2 2
Swelling/ Edema 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Shock from Patient Lead(s) 1 1
Complete Heart Block 1 1
Discomfort 1 1
Pain 1 1
Ventricular Fibrillation 1 1
Abrasion 1 1
Exposure to Body Fluids 1 1
Stroke/CVA 1 1
Chest Pain 1 1
Erythema 1 1
Eye Injury 1 1
Foreign Body Sensation in Eye 1 1
Hypersensitivity/Allergic reaction 1 1
Ischemia 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corporation II Jan-10-2024
2 Baxter Healthcare Corporation II Jan-24-2023
3 GE Healthcare, LLC II Dec-07-2020
4 Philips North America, LLC II Jun-10-2020
5 Philips North America, LLC II Feb-21-2019
6 WELCH ALLYN, INC/MORTARA II Dec-09-2020
7 WELCH ALLYN, INC/MORTARA II Apr-29-2020
8 Welch Allyn Inc Mortara II Oct-02-2021
9 Welch Allyn Inc Mortara II Apr-22-2021
10 Withings II Mar-22-2023
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