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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
ALIVECOR, INC.
  SUBSTANTIALLY EQUIVALENT 1
AMCG CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
B-SECUR LTD.
  SUBSTANTIALLY EQUIVALENT 1
BIONET CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
CAF MEDICAL SOLUTIONS INC.
  SUBSTANTIALLY EQUIVALENT 1
CARDIACSENSE
  SUBSTANTIALLY EQUIVALENT 2
CARDIOLOGS TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
COALA LIFE AB
  SUBSTANTIALLY EQUIVALENT 1
EDAN INSTRUMENTS, INC
  SUBSTANTIALLY EQUIVALENT 1
EDAN INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 2
EKGENIUS LLC
  SUBSTANTIALLY EQUIVALENT 1
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
GENETESIS INC.
  SUBSTANTIALLY EQUIVALENT 1
IMEDRIX INC. (FORMERLY PIITECH INC.)
  SUBSTANTIALLY EQUIVALENT 1
MASIMO CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
MEDIBLU MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
MEDICALGORITHMICS S.A.
  SUBSTANTIALLY EQUIVALENT 1
MEDIZIN SYSTEME BOBLINGEN GMBH
  SUBSTANTIALLY EQUIVALENT 1
MESI, DEVELOPMENT OF MEDICAL DEVICES, LTD; MESI, D.O.O.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 2
PHYSIQ, INC
  SUBSTANTIALLY EQUIVALENT 2
SCHILLER AG
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN CAREWELL ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN LE MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TRISMED CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
WITHINGS
  SUBSTANTIALLY EQUIVALENT 1
WITHINGS SA
  SUBSTANTIALLY EQUIVALENT 1
ZOLL MANUFACTURING CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 27 27
2020 59 59
2021 24 24
2022 59 59
2023 54 54
2024 61 67

Device Problems MDRs with this Device Problem Events in those MDRs
Wireless Communication Problem 82 82
Patient Data Problem 30 30
Intermittent Communication Failure 29 29
Fire 15 15
Unable to Obtain Readings 11 11
Incorrect, Inadequate or Imprecise Result or Readings 9 15
Sparking 7 7
Detachment of Device or Device Component 7 7
Insufficient Information 7 7
Therapeutic or Diagnostic Output Failure 6 6
Smoking 6 6
Incorrect Measurement 5 11
No Display/Image 5 5
Battery Problem 5 5
Incorrect Interpretation of Signal 4 4
Data Problem 4 4
Computer Operating System Problem 4 4
Improper or Incorrect Procedure or Method 3 3
Connection Problem 3 3
Appropriate Term/Code Not Available 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Application Program Problem 3 3
Display Difficult to Read 3 3
Output Problem 3 3
Mechanical Problem 3 3
Break 3 3
Defective Component 2 2
Disconnection 2 2
Image Display Error/Artifact 2 2
High Readings 2 8
Operating System Version or Upgrade Problem 2 2
Loose or Intermittent Connection 2 2
Program or Algorithm Execution Problem 2 2
Use of Device Problem 2 2
Leak/Splash 2 2
Excessive Heating 2 2
Device Emits Odor 2 2
Product Quality Problem 2 2
Computer Software Problem 2 2
Noise, Audible 1 1
Temperature Problem 1 1
Signal Artifact/Noise 1 1
Capturing Problem 1 1
Electrical /Electronic Property Problem 1 1
Self-Activation or Keying 1 1
Unexpected Therapeutic Results 1 1
Failure to Read Input Signal 1 1
Compatibility Problem 1 1
Protective Measures Problem 1 1
Explosion 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 158 164
No Patient Involvement 50 50
Insufficient Information 25 25
No Known Impact Or Consequence To Patient 23 23
No Consequences Or Impact To Patient 6 6
Superficial (First Degree) Burn 4 4
Electric Shock 4 4
Death 4 4
Myocardial Infarction 4 4
Cardiac Arrest 2 2
Burn(s) 2 2
Burning Sensation 2 2
Eye Pain 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Foreign Body Sensation in Eye 1 1
Stroke/CVA 1 1
Hypersensitivity/Allergic reaction 1 1
Arrhythmia 1 1
Shock from Patient Lead(s) 1 1
Ischemia 1 1
Complete Heart Block 1 1
Abrasion 1 1
Myocarditis 1 1
Ventricular Fibrillation 1 1
Exposure to Body Fluids 1 1
Erythema 1 1
Discomfort 1 1
Chest Pain 1 1
Pain 1 1
Eye Injury 1 1
Swelling/ Edema 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corporation II Nov-07-2024
2 Baxter Healthcare Corporation II Jul-10-2024
3 Baxter Healthcare Corporation II Jan-10-2024
4 Baxter Healthcare Corporation II Jan-24-2023
5 GE Healthcare, LLC II Dec-07-2020
6 Philips North America, LLC II Jun-10-2020
7 Philips North America, LLC II Feb-21-2019
8 Schiller, Ag II Aug-27-2024
9 WELCH ALLYN, INC/MORTARA II Dec-09-2020
10 WELCH ALLYN, INC/MORTARA II Apr-29-2020
11 Welch Allyn Inc Mortara II Oct-02-2021
12 Welch Allyn Inc Mortara II Apr-22-2021
13 Withings II Mar-22-2023
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