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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 2
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 1
SHENZHEN CAREWELL ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
VALES & HILLS BIOMEDICAL TECH. LTD.
  SUBSTANTIALLY EQUIVALENT 1
VECTRACOR, INC.
  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 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Wireless Communication Problem 42 42
Unable to Obtain Readings 18 18
Device Operates Differently Than Expected 7 7
Fire 6 6
No Display/Image 5 5
Incorrect, Inadequate or Imprecise Resultor Readings 5 5
Data Problem 5 5
Device Inoperable 4 4
Connection Problem 4 4
Adverse Event Without Identified Device or Use Problem 3 3
Smoking 3 3
Break 3 3
Computer Operating System Problem 3 3
No Device Output 2 2
Output Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Insufficient Information 2 2
Patient Data Problem 2 2
Incorrect Measurement 2 2
Sparking 2 2
Image Display Error/Artifact 2 2
Device Displays Incorrect Message 2 2
Application Interface Becomes Non-Functional Or Program Exits Abnormally 2 2
Disconnection 1 1
Device Alarm System 1 1
Thermal Decomposition of Device 1 1
Computer Software 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
Device Stops Intermittently 1 1
Malposition of Device 1 1
Device Damaged Prior to Use 1 1
Inappropriate Waveform 1 1
Device Markings/Labelling Problem 1 1
Improper Device Output 1 1
Compatibility Problem 1 1
Power Problem 1 1
Explosion 1 1
Application Program Freezes, Becomes Nonfunctional 1 1
Patient-Device Incompatibility 1 1
Application Program Problem 1 1
Communication or Transmission Problem 1 1
Use of Device Problem 1 1
Date/Time-Related Software Problem 1 1
Defective Device 1 1
Device Emits Odor 1 1
Labelling, Instructions for Use or Training Problem 1 1
Crack 1 1
Electromagnetic Interference 1 1
Device Handling Problem 1 1
Noise, Audible 1 1
Programming Issue 1 1
Protective Measures Problem 1 1
Signal Artifact/Noise 1 1
Unexpected Shutdown 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 62 62
No Known Impact Or Consequence To Patient 40 40
No Consequences Or Impact To Patient 10 10
No Clinical Signs, Symptoms or Conditions 8 8
Death 5 5
Myocardial Infarction 5 5
Cardiac Arrest 2 2
No Information 2 2
Electric Shock 2 2
Insufficient Information 2 2
Burn(s) 2 2
High Blood Pressure/ Hypertension 1 1
Ischemia 1 1
Skin Irritation 1 1
Complete Heart Block 1 1
No Code Available 1 1
Patient Problem/Medical Problem 1 1
Stroke/CVA 1 1
Chest Pain 1 1
Left Ventricular Dysfunction 1 1
Tingling 1 1
Injury 1 1
Burn, Thermal 1 1

Recalls
Manufacturer Recall Class Date Posted
1 GE Healthcare, LLC II Dec-07-2020
2 Philips North America, LLC II Jun-10-2020
3 Philips North America, LLC II Feb-21-2019
4 WELCH ALLYN, INC/MORTARA II Dec-09-2020
5 WELCH ALLYN, INC/MORTARA II Apr-29-2020
6 Welch Allyn Inc Mortara II Apr-22-2021
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