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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device electrocardiograph
Regulation Description Electrocardiograph.
Product CodeDPS
Regulation Number 870.2340
Device Class 2


Premarket Reviews
ManufacturerDecision
ACME PORTABLE MACHINES, INC.
  SUBSTANTIALLY EQUIVALENT 1
CARDIOLOGS TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
CONTEC MEDICAL SYSTEMS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
CONTEC MEDICAL SYSTEMS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
EDAN INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 6
FUKUDA DENSHI CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
FUKUDA DENSHI USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MITAC INTERNATIONAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
MORTARA
  SUBSTANTIALLY EQUIVALENT 1
MORTARA INSTRUMENT, INC.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS INTERNATIONAL BV
  SUBSTANTIALLY EQUIVALENT 1
SCHILLER
  SUBSTANTIALLY EQUIVALENT 3
SCHILLER AG
  SUBSTANTIALLY EQUIVALENT 3
SHENZHEN BIOCARE BIO-MEDICAL EQUIPMENT CO., LTD
  SUBSTANTIALLY EQUIVALENT 4
SHENZHEN CAREWELL ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SPAULDING CLINICAL RESEARCH, LLC
  SUBSTANTIALLY EQUIVALENT 1
  1.  K150564  Spaulding Electrocardiograph 2100iQ
VALES & HILLS BIOMEDICAL TECH. LTD.
  SUBSTANTIALLY EQUIVALENT 1
VECTRACOR, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZOLL MANUFACTURING CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ZYWIE, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 31 31
2016 12 12
2017 15 15
2018 19 19
2019 27 27
2020 48 48

Device Problems MDRs with this Device Problem Events in those MDRs
Wireless Communication Problem 28 28
Unable to Obtain Readings 18 18
Device Operates Differently Than Expected 12 12
Data Problem 7 7
Device Displays Incorrect Message 6 6
Fire 6 6
Incorrect, Inadequate or Imprecise Resultor Readings 5 5
Improper or Incorrect Procedure or Method 5 5
Device Inoperable 5 5
Patient Data Problem 5 5
Connection Problem 5 5
Adverse Event Without Identified Device or Use Problem 4 4
No Display/Image 4 4
Break 3 3
Smoking 3 3
Output Problem 3 3
Use of Device Problem 3 3
Computer Operating System Problem 3 3
Failure to Read Input Signal 2 2
Sparking 2 2
Therapeutic or Diagnostic Output Failure 2 2
Switch, Push Button 2 2
Noise, Audible 2 2
No Device Output 2 2
Image Display Error/Artifact 2 2
Incorrect Measurement 2 2
Cable, Electrical 2 2
Electromagnetic Interference 2 2
Electrical /Electronic Property Problem 2 2
Screen 2 2
Device Alarm System 2 2
Signal Artifact/Noise 2 2
Application Interface Becomes Non-Functional Or Program Exits Abnormally 2 2
Failure to Discharge 2 2
Display or Visual Feedback Problem 1 1
Keyboard/Keypad 1 1
Power Cord 1 1
Caster 1 1
Cover 1 1
Monitor 1 1
Thermal Decomposition of Device 1 1
Computer Software Problem 1 1
Crack 1 1
Nonstandard Device 1 1
Labelling, Instructions for Use or Training Problem 1 1
Incorrect Interpretation of Signal 1 1
Material Rupture 1 1
Self-Activation or Keying 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Battery 1 1
Device Stops Intermittently 1 1
Inappropriate Waveform 1 1
Date/Time-Related Software Problem 1 1
Defective Device 1 1
Explosion 1 1
Unexpected Shutdown 1 1
Application Program Freezes, Becomes Nonfunctional 1 1
Insufficient Information 1 1
Device Markings/Labelling Problem 1 1
Power Problem 1 1
Programming Issue 1 1
Protective Measures Problem 1 1
Malposition of Device 1 1
Patient-Device Incompatibility 1 1
Application Network Problem 1 1
Application Program Problem 1 1
Charging Problem 1 1
Communication or Transmission Problem 1 1
Device Sensing Problem 1 1
Improper Device Output 1 1
Compatibility Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 54 54
No Patient Involvement 50 50
No Consequences Or Impact To Patient 10 10
Death 7 7
Myocardial Infarction 6 6
No Information 4 4
No Code Available 4 4
No Clinical Signs, Symptoms or Conditions 4 4
Cardiac Arrest 3 3
Injury 2 2
Electric Shock 2 2
Burn(s) 2 2
Fall 1 1
High Blood Pressure/ Hypertension 1 1
Ischemia 1 1
Skin Irritation 1 1
Irregular Pulse 1 1
Complete Heart Block 1 1
Insufficient Information 1 1
Atrial Fibrillation 1 1
Patient Problem/Medical Problem 1 1
Burn, Thermal 1 1
Tachycardia 1 1
Tingling 1 1
Stroke/CVA 1 1
Chest Pain 1 1
Left Ventricular Dysfunction 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Mortara Instrument, Inc II Jun-12-2015
2 Philips North America, LLC II Jun-10-2020
3 Philips North America, LLC II Feb-21-2019
4 WELCH ALLYN, INC/MORTARA II Apr-29-2020
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