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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
ADVANCED INSTRUMENTATIONS, INC.
  SUBSTANTIALLY EQUIVALENT 2
ALIVECOR, INC.
  SUBSTANTIALLY EQUIVALENT 3
AMCG CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ANDON HEALTH CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
ANYBATTERY, INC.
  SUBSTANTIALLY EQUIVALENT 1
B-SECUR LTD.
  SUBSTANTIALLY EQUIVALENT 1
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
BIOCARE BIO-MEDICAL EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BIOMAGNETIK-PARK GMBH
  SUBSTANTIALLY EQUIVALENT 1
BIONET CO., LTD.
  SUBSTANTIALLY EQUIVALENT 5
BONUS COMMUNICACIONES SRL
  SUBSTANTIALLY EQUIVALENT 1
BRENTWOOD MEDICAL TECHNOLOGY CORP.
  SUBSTANTIALLY EQUIVALENT 1
BSP-BIIOLOGICAL SIGNAL PROCESSING, LTD.
  SUBSTANTIALLY EQUIVALENT 1
CAF MEDICAL SOLUTIONS INC.
  SUBSTANTIALLY EQUIVALENT 1
CAIRD TECHNOLOGY
  SUBSTANTIALLY EQUIVALENT 1
CARDEA ASSOCIATES INC
  SUBSTANTIALLY EQUIVALENT 1
CARDIAC SCIENCE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
CARDIACSENSE
  SUBSTANTIALLY EQUIVALENT 1
CARDIO COMM SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 2
CARDIO-PHOENIX INC.
  SUBSTANTIALLY EQUIVALENT 2
CARDIOCOMM SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
CARDIOLINE S.P.A
  SUBSTANTIALLY EQUIVALENT 2
CARDIOLOGS TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 2
COALA LIFE AB
  SUBSTANTIALLY EQUIVALENT 1
COMMWELL LTD.
  SUBSTANTIALLY EQUIVALENT 1
CONTEC MEDICAL SYSTEM CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
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
DIMETEK DIGITAL MEDICAL TECHNOLOGIES LTD
  SUBSTANTIALLY EQUIVALENT 1
DYANSYS, INC.
  SUBSTANTIALLY EQUIVALENT 2
DYNACARDIA, INC.
  SUBSTANTIALLY EQUIVALENT 1
EDAN INSTRUMENTS INC
  SUBSTANTIALLY EQUIVALENT 1
EDAN INSTRUMENTS, INC
  SUBSTANTIALLY EQUIVALENT 1
EDAN INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 16
EKGENIUS LLC
  SUBSTANTIALLY EQUIVALENT 1
ET MEDICAL DEVICES SPA
  SUBSTANTIALLY EQUIVALENT 1
FUKUDA DENSHI USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
GE MEDICAL SYST. INFORMATION TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
GE MEDICAL SYSTEMS CHINA CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC
  SUBSTANTIALLY EQUIVALENT 2
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 3
GEM-MED S.L.
  SUBSTANTIALLY EQUIVALENT 1
GENETESIS INC.
  SUBSTANTIALLY EQUIVALENT 1
GUANGDONG BIOLIGHT MEDITECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HARBINGER MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
HHSSYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 1
IMEDRIX INC. (FORMERLY PIITECH INC.)
  SUBSTANTIALLY EQUIVALENT 1
INVISIONHEART INC.
  SUBSTANTIALLY EQUIVALENT 1
MASIMO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
MDOLORIS MEDICAL SYSTEMS SAS
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL POSITIONING, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL PREDICTIVE SCIENCE CORP.
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL PREDICTIVE SCIENCE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
MEDIZIN SYSTEME BOBLINGEN GMBH
  SUBSTANTIALLY EQUIVALENT 1
MEMTEC CORP.
  SUBSTANTIALLY EQUIVALENT 1
MERIDIAN DYNAMICS BIOMEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
MESI, DEVELOPMENT OF MEDICAL DEVICES, LTD; MESI, D.O.O.
  SUBSTANTIALLY EQUIVALENT 1
MITAC INTERNATIONAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
MOBHEALTH INCORPORATION
  SUBSTANTIALLY EQUIVALENT 1
MORTARA INSTRUMENT, INC
  SUBSTANTIALLY EQUIVALENT 3
MORTARA INSTRUMENT, INC.
  SUBSTANTIALLY EQUIVALENT 7
PHILIPS HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 5
PHYSIQ INC.
  SUBSTANTIALLY EQUIVALENT 1
PHYSIQ, INC
  SUBSTANTIALLY EQUIVALENT 2
PULSE BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
REKA PTE LTD
  SUBSTANTIALLY EQUIVALENT 1
SAMSUNG STRATEGY AND INNOVATION CENTER (SSIC)
  SUBSTANTIALLY EQUIVALENT 1
SCHILLER AG
  SUBSTANTIALLY EQUIVALENT 3
SHENZHEN BIOCARE BIO-MEDICAL EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 5
SHENZHEN BIOCARE ELECTRONICS CO., LTD
  SUBSTANTIALLY EQUIVALENT 4
SHENZHEN CAREWELL ELECTRONICS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN CAREWELL ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SONOSCAPE COMPANY LIMITED
  SUBSTANTIALLY EQUIVALENT 1
SPACELABS HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 1
SPAULDING CLINICAL RESEARCH, LLC
  SUBSTANTIALLY EQUIVALENT 2
SUZUKEN CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
TAIDOC TECHNOLOGY CORPORATION
  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
VECTRACOR, INC.
  SUBSTANTIALLY EQUIVALENT 1
VICOR TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
WELCH ALLYN
  SUBSTANTIALLY EQUIVALENT 1
WELCH ALLYN, INC.
  SUBSTANTIALLY EQUIVALENT 1
WIPRO GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1
WITHINGS
  SUBSTANTIALLY EQUIVALENT 1
WITHINGS SA
  SUBSTANTIALLY EQUIVALENT 1
ZOLL MANUFACTURING CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ZYWIE, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 15 15
2015 31 31
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 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 23 23
Unable to Obtain Readings 18 18
Fire 16 16
Device Operates Differently Than Expected 13 13
Device Displays Incorrect Message 9 9
Incorrect, Inadequate or Imprecise Result or Readings 9 9
No Display/Image 8 8
Improper or Incorrect Procedure or Method 8 8
Data Problem 8 8
Insufficient Information 8 8
Therapeutic or Diagnostic Output Failure 6 6
Device Inoperable 6 6
Adverse Event Without Identified Device or Use Problem 6 6
Output Problem 6 6
Connection Problem 6 6
Battery Problem 5 5
Smoking 5 5
Sparking 5 5
Appropriate Term/Code Not Available 5 5
Use of Device Problem 4 4
Computer Operating System Problem 4 4
Break 4 4
Incorrect Measurement 4 4
Mechanical Problem 3 3
Signal Artifact/Noise 3 3
Failure to Discharge 3 3
Display Difficult to Read 3 3
Electrical /Electronic Property Problem 3 3
Application Program Problem 3 3
Detachment of Device or Device Component 3 3
Operating System Version or Upgrade Problem 2 2
Device Sensing Problem 2 2
Device Stops Intermittently 2 2
Inappropriate/Inadequate Shock/Stimulation 2 2
Failure to Read Input Signal 2 2
Defective Component 2 2
Electromagnetic Interference 2 2
Disconnection 2 2
Device Alarm System 2 2
Application Interface Becomes Non-Functional Or Program Exits Abnormally 2 2
Thermal Decomposition of Device 2 2
Loose or Intermittent Connection 2 2
Product Quality Problem 2 2
Image Display Error/Artifact 2 2
Device Emits Odor 2 2
No Device Output 2 2
Programming Issue 2 2
Excessive Heating 2 2
Noise, Audible 2 2
Program or Algorithm Execution Problem 2 2
Application Program Freezes, Becomes Nonfunctional 1 1
Patient Device Interaction Problem 1 1
Explosion 1 1
Device Fell 1 1
Unexpected Shutdown 1 1
Protective Measures Problem 1 1
Temperature Problem 1 1
Device Handling Problem 1 1
Overheating of Device 1 1
Failure to Power Up 1 1
Device Difficult to Program or Calibrate 1 1
Labelling, Instructions for Use or Training Problem 1 1
Leak/Splash 1 1
Nonstandard Device 1 1
Incorrect Interpretation of Signal 1 1
Material Rupture 1 1
Self-Activation or Keying 1 1
Failure to Capture 1 1
Computer Software Problem 1 1
Crack 1 1
Inability to Auto-Fill 1 1
Display or Visual Feedback Problem 1 1
Failure to Deliver Energy 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
Application Network Problem 1 1
Unexpected Therapeutic Results 1 1
Device Damaged Prior to Use 1 1
Improper Device Output 1 1
Compatibility Problem 1 1
Power Problem 1 1
Device Markings/Labelling Problem 1 1
Capturing Problem 1 1
Charging Problem 1 1
Communication or Transmission Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 114 114
No Patient Involvement 69 69
No Known Impact Or Consequence To Patient 61 62
Insufficient Information 21 21
No Consequences Or Impact To Patient 12 12
Death 7 7
Myocardial Infarction 6 6
No Code Available 6 6
Cardiac Arrest 5 5
Superficial (First Degree) Burn 4 4
Electric Shock 4 4
Burn(s) 4 4
No Information 4 4
Chest Pain 2 2
Burning Sensation 2 2
Injury 2 2
Eye Pain 2 2
Swelling/ Edema 1 1
Shock from Patient Lead(s) 1 1
Complete Heart Block 1 1
Patient Problem/Medical Problem 1 1
Irregular Pulse 1 1
Burn, Thermal 1 1
Discomfort 1 1
Misdiagnosis 1 1
Tingling 1 1
Stroke/CVA 1 1
Abrasion 1 1
Atrial Fibrillation 1 1
Exposure to Body Fluids 1 1
Pain 1 1
Skin Irritation 1 1
Tachycardia 1 1
Ventricular Fibrillation 1 1
Erythema 1 1
Eye Injury 1 1
Fall 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
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 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 Del Mar Reynolds Medical, Ltd. II Jan-13-2012
4 Edan Instruments, Inc. II Oct-12-2011
5 GE Healthcare, LLC II Dec-07-2020
6 GE Medical Systems, LLC II Jan-21-2010
7 Mortara Instrument, Inc II Jun-12-2015
8 Philips Healthcare Inc. II Jun-17-2011
9 Philips North America, LLC II Jun-10-2020
10 Philips North America, LLC II Feb-21-2019
11 WELCH ALLYN, INC/MORTARA II Dec-09-2020
12 WELCH ALLYN, INC/MORTARA II Apr-29-2020
13 Welch Allyn Inc Mortara II Oct-02-2021
14 Welch Allyn Inc Mortara II Apr-22-2021
15 Withings II Mar-22-2023
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