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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
B-SECUR LTD.
  SUBSTANTIALLY EQUIVALENT 1
BIONET CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
CAF MEDICAL SOLUTIONS INC.
  SUBSTANTIALLY EQUIVALENT 1
CARDIACSENSE
  SUBSTANTIALLY EQUIVALENT 1
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 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
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 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Wireless Communication Problem 62 62
Intermittent Communication Failure 27 27
Patient Data Problem 20 20
Fire 14 14
Unable to Obtain Readings 11 11
Insufficient Information 7 7
Therapeutic or Diagnostic Output Failure 6 6
Incorrect, Inadequate or Imprecise Result or Readings 6 6
Smoking 5 5
Sparking 5 5
No Display/Image 5 5
Computer Operating System Problem 4 4
Battery Problem 4 4
Adverse Event Without Identified Device or Use Problem 3 3
Connection Problem 3 3
Detachment of Device or Device Component 3 3
Application Program Problem 3 3
Output Problem 3 3
Appropriate Term/Code Not Available 3 3
Data Problem 3 3
Mechanical Problem 3 3
Break 3 3
Display Difficult to Read 3 3
Improper or Incorrect Procedure or Method 3 3
Product Quality Problem 2 2
Use of Device Problem 2 2
Defective Component 2 2
Loose or Intermittent Connection 2 2
Incorrect Measurement 2 2
Disconnection 2 2
Device Emits Odor 2 2
Image Display Error/Artifact 2 2
Operating System Version or Upgrade Problem 2 2
Excessive Heating 2 2
Program or Algorithm Execution Problem 2 2
Patient Device Interaction Problem 1 1
Explosion 1 1
Device Fell 1 1
Unexpected Shutdown 1 1
Capturing Problem 1 1
Compatibility Problem 1 1
Device Handling Problem 1 1
Noise, Audible 1 1
Protective Measures Problem 1 1
Temperature Problem 1 1
Leak/Splash 1 1
Electrical /Electronic Property Problem 1 1
Overheating of Device 1 1
Failure to Power Up 1 1
Device Difficult to Program or Calibrate 1 1
Device Alarm System 1 1
Signal Artifact/Noise 1 1
Inability to Auto-Fill 1 1
Thermal Decomposition of Device 1 1
Failure to Capture 1 1
Computer Software Problem 1 1
Unexpected Therapeutic Results 1 1
Material Rupture 1 1
Self-Activation or Keying 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Failure to Read Input Signal 1 1
Defective Device 1 1
Malposition of Device 1 1
Device Damaged Prior to Use 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 108 108
No Patient Involvement 50 50
No Known Impact Or Consequence To Patient 23 23
Insufficient Information 21 21
No Consequences Or Impact To Patient 6 6
Myocardial Infarction 4 4
Death 4 4
Superficial (First Degree) Burn 4 4
Electric Shock 3 3
Burn(s) 2 2
Cardiac Arrest 2 2
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
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
Complete Heart Block 1 1
Discomfort 1 1
Pain 1 1
Ventricular Fibrillation 1 1
Abrasion 1 1
Exposure to Body Fluids 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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