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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
ACME PORTABLE MACHINES, INC.
  SUBSTANTIALLY EQUIVALENT 1
AMCG CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ANYBATTERY, INC.
  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 2
CARDIO-PHOENIX INC.
  SUBSTANTIALLY EQUIVALENT 1
CARDIOLINE S.P.A
  SUBSTANTIALLY EQUIVALENT 2
CARDIOLOGS TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 2
COALA LIFE AB
  SUBSTANTIALLY EQUIVALENT 1
CONTEC MEDICAL SYSTEMS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
CONTEC MEDICAL SYSTEMS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CONTEC MEDICAL SYSTEMS CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
CORSCIENCE GMBH & CO.
  SUBSTANTIALLY EQUIVALENT 1
CREAVO MEDICAL TECHNOLOGIES, LTD.
  SUBSTANTIALLY EQUIVALENT 1
DAILYCARE BIOMEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
EDAN INSTRUMENTS, INC
  SUBSTANTIALLY EQUIVALENT 1
EDAN INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 8
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
MDOLORIS MEDICAL SYSTEMS SAS
  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
MORTARA INSTRUMENT, INC.
  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 3
SHENZHEN BIOCARE BIO-MEDICAL EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN CAREWELL ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SUZUKEN CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
TRISMED CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TRISTAN TECHNOLOGIES, INC
  SUBSTANTIALLY EQUIVALENT 1
VALES & HILLS BIOMEDICAL TECH. 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
2016 12 12
2017 15 15
2018 19 19
2019 27 27
2020 59 59
2021 24 24
2022 59 59
2023 54 54
2024 17 17

Device Problems MDRs with this Device Problem Events in those MDRs
Wireless Communication Problem 69 69
Intermittent Communication Failure 27 27
Patient Data Problem 20 20
Unable to Obtain Readings 18 18
Fire 16 16
Incorrect, Inadequate or Imprecise Result or Readings 9 9
Insufficient Information 8 8
Device Operates Differently Than Expected 7 7
No Display/Image 7 7
Therapeutic or Diagnostic Output Failure 6 6
Data Problem 6 6
Connection Problem 5 5
Battery Problem 5 5
Sparking 5 5
Smoking 5 5
Device Inoperable 4 4
Incorrect Measurement 4 4
Break 4 4
Computer Operating System Problem 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Output Problem 4 4
Appropriate Term/Code Not Available 3 3
Application Program Problem 3 3
Detachment of Device or Device Component 3 3
Display Difficult to Read 3 3
Mechanical Problem 3 3
Improper or Incorrect Procedure or Method 3 3
Use of Device Problem 2 2
Inappropriate/Inadequate Shock/Stimulation 2 2
Device Emits Odor 2 2
No Device Output 2 2
Loose or Intermittent Connection 2 2
Image Display Error/Artifact 2 2
Thermal Decomposition of Device 2 2
Application Interface Becomes Non-Functional Or Program Exits Abnormally 2 2
Disconnection 2 2
Product Quality Problem 2 2
Device Displays Incorrect Message 2 2
Defective Component 2 2
Operating System Version or Upgrade Problem 2 2
Program or Algorithm Execution Problem 2 2
Excessive Heating 2 2
Application Program Freezes, Becomes Nonfunctional 1 1
Power Problem 1 1
Programming Issue 1 1
Protective Measures Problem 1 1
Temperature Problem 1 1
Device Handling Problem 1 1
Noise, Audible 1 1
Patient Device Interaction Problem 1 1
Explosion 1 1
Device Fell 1 1
Unexpected Shutdown 1 1
Inappropriate Waveform 1 1
Date/Time-Related Software Problem 1 1
Defective Device 1 1
Malposition of Device 1 1
Patient-Device Incompatibility 1 1
Device Markings/Labelling Problem 1 1
Improper Device Output 1 1
Compatibility Problem 1 1
Capturing Problem 1 1
Communication or Transmission Problem 1 1
Device Alarm System 1 1
Signal Artifact/Noise 1 1
Inability to Auto-Fill 1 1
Failure to Capture 1 1
Computer Software Problem 1 1
Crack 1 1
Labelling, Instructions for Use or Training Problem 1 1
Leak/Splash 1 1
Electromagnetic Interference 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
Material Rupture 1 1
Self-Activation or Keying 1 1
Failure to Read Input Signal 1 1
Device Stops Intermittently 1 1
Unexpected Therapeutic Results 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 121 121
No Patient Involvement 62 62
No Known Impact Or Consequence To Patient 40 40
Insufficient Information 21 21
No Consequences Or Impact To Patient 10 10
Death 5 5
Myocardial Infarction 5 5
Burn(s) 4 4
Cardiac Arrest 4 4
Electric Shock 4 4
Superficial (First Degree) Burn 4 4
No Information 2 2
Eye Pain 2 2
Burning Sensation 2 2
Chest Pain 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Tingling 1 1
Complete Heart Block 1 1
Discomfort 1 1
Injury 1 1
Burn, Thermal 1 1
Swelling/ Edema 1 1
No Code Available 1 1
Patient Problem/Medical Problem 1 1
Shock from Patient Lead(s) 1 1
Stroke/CVA 1 1
Abrasion 1 1
Exposure to Body Fluids 1 1
Pain 1 1
Skin Irritation 1 1
Ventricular Fibrillation 1 1
Erythema 1 1
Eye Injury 1 1
Foreign Body Sensation in Eye 1 1
Hypersensitivity/Allergic reaction 1 1
High Blood Pressure/ Hypertension 1 1
Ischemia 1 1
Left Ventricular Dysfunction 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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