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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)
Regulation Description Medical magnetic tape recorder.
Product CodeMWJ
Regulation Number 870.2800
Device Class 2


Premarket Reviews
ManufacturerDecision
MORTARA INSTRUMENT, INC
  SUBSTANTIALLY EQUIVALENT 1
NORAV MEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 1
SENSYDIA, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPACELABS HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 1 1
2017 2 2
2018 1 1
2019 4 4
2020 12 12
2021 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Device Displays Incorrect Message 5 5
Temperature Problem 4 4
Data Problem 3 3
Insufficient Information 2 2
Fluid Leak 2 2
Computer Operating System Problem 2 2
Device Operates Differently Than Expected 2 2
Overheating of Device 2 2
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
Inappropriate or Unexpected Reset 1 1
Output Problem 1 1
Power Problem 1 1
Melted 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
Insufficient Information 3 3
No Clinical Signs, Symptoms or Conditions 2 2
Burn(s) 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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