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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device electrocardiograph, ambulatory (without analysis)
Product CodeMWJ
Regulation Number 870.2800
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOTRICITY
  SUBSTANTIALLY EQUIVALENT 2
MEDICALGORITHMICS S.A.
  SUBSTANTIALLY EQUIVALENT 1
SENSYDIA, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPACELABS HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 2 2
2018 1 1
2019 4 4
2020 12 12
2021 3 3
2022 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Device Displays Incorrect Message 5 5
Overheating of Device 4 4
Temperature Problem 4 4
Data Problem 3 3
Insufficient Information 2 2
Computer Operating System Problem 2 2
Fluid Leak 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Output Problem 1 1
Power Problem 1 1
Melted 1 1
Device Operates Differently Than Expected 1 1
Improper Chemical Reaction 1 1
Inappropriate or Unexpected Reset 1 1
Material Too Rigid or Stiff 1 1
Smoking 1 1
Use of Device Problem 1 1
Visual Prompts will not Clear 1 1
Date/Time-Related Software Problem 1 1
Break 1 1
No Display/Image 1 1
Display or Visual Feedback Problem 1 1
Fire 1 1
Therapeutic or Diagnostic Output Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 12 12
No Information 4 4
No Clinical Signs, Symptoms or Conditions 4 4
Insufficient Information 3 3
Skin Inflammation/ Irritation 1 1
Hypersensitivity/Allergic reaction 1 1
Skin Irritation 1 1
Burning Sensation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Braemar Manufacturing, LLC II Mar-10-2020
2 Philips North America, LLC II Feb-21-2020
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