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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
B-SECUR LTD.
  SUBSTANTIALLY EQUIVALENT 1
BIOCARE BIO-MEDICAL EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BIONET CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
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 2
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
MEDICAL PREDICTIVE SCIENCE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
MEDIZIN SYSTEME BOBLINGEN GMBH
  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
VECTRACOR, INC.
  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 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
Wireless Communication Problem 52 52
Intermittent Communication Failure 26 26
Unable to Obtain Readings 16 16
Fire 15 15
Patient Data Problem 13 13
No Display/Image 7 7
Incorrect, Inadequate or Imprecise Result or Readings 6 6
Smoking 5 5
Sparking 5 5
Insufficient Information 5 5
Therapeutic or Diagnostic Output Failure 4 4
Computer Operating System Problem 4 4
Connection Problem 4 4
Data Problem 4 4
Detachment of Device or Device Component 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Output Problem 3 3
Mechanical Problem 3 3
Break 3 3
Display Difficult to Read 3 3
Disconnection 2 2
Thermal Decomposition of Device 2 2
Device Emits Odor 2 2
Image Display Error/Artifact 2 2
Improper or Incorrect Procedure or Method 2 2
Defective Component 2 2
Incorrect Measurement 2 2
Application Program Problem 2 2
Battery Problem 2 2
Program or Algorithm Execution Problem 2 2
Patient Device Interaction Problem 1 1
Explosion 1 1
Unexpected Shutdown 1 1
Application Program Freezes, Becomes Nonfunctional 1 1
Capturing Problem 1 1
Appropriate Term/Code Not Available 1 1
Device Handling Problem 1 1
Noise, Audible 1 1
Power Problem 1 1
Protective Measures Problem 1 1
Temperature Problem 1 1
Device Operates Differently Than Expected 1 1
Compatibility Problem 1 1
Inappropriate Waveform 1 1
Defective Device 1 1
Device Displays Incorrect Message 1 1
Device Damaged Prior to Use 1 1
Malposition of Device 1 1
Device Stops Intermittently 1 1
Unexpected Therapeutic Results 1 1
Use of Device Problem 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
Labelling, Instructions for Use or Training Problem 1 1
Electrical /Electronic Property Problem 1 1
No Device Output 1 1
Failure to Power Up 1 1
Product Quality Problem 1 1
Failure to Capture 1 1
Computer Software Problem 1 1
Crack 1 1
Device Alarm System 1 1
Signal Artifact/Noise 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 81 81
No Patient Involvement 56 56
No Known Impact Or Consequence To Patient 31 31
Insufficient Information 11 11
No Consequences Or Impact To Patient 9 9
Death 4 4
Myocardial Infarction 4 4
Electric Shock 3 3
Burn(s) 3 3
Cardiac Arrest 2 2
Ventricular Fibrillation 1 1
Shock from Patient Lead(s) 1 1
Hypersensitivity/Allergic reaction 1 1
Complete Heart Block 1 1
Stroke/CVA 1 1
Ischemia 1 1
Burning Sensation 1 1

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