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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
BIOTRICITY
  SUBSTANTIALLY EQUIVALENT 2
HEARTBEAM, INC.
  SUBSTANTIALLY EQUIVALENT 1
KESTRA MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDICALGORITHMICS S.A.
  SUBSTANTIALLY EQUIVALENT 1
SPACELABS HEALTHCARE, LTD.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2021 3 3
2022 6 6
2023 5 5
2024 3 3
2025 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Overheating of Device 6 6
Adverse Event Without Identified Device or Use Problem 4 4
Output Problem 2 2
Defective Device 2 2
Patient Device Interaction Problem 2 2
Data Problem 2 2
Device Sensing Problem 2 2
Display or Visual Feedback Problem 2 2
Fluid/Blood Leak 2 2
Disconnection 1 1
Break 1 1
Mechanical Problem 1 1
Patient-Device Incompatibility 1 1
Wireless Communication Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Problem with Software Installation 1 1
Material Too Rigid or Stiff 1 1
Component Missing 1 1
Product Quality Problem 1 1
Telemetry Discrepancy 1 1
Explosion 1 1
Excessive Heating 1 1
Improper Chemical Reaction 1 1
Improper or Incorrect Procedure or Method 1 1
Device Displays Incorrect Message 1 1
Loss of Data 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 9 9
Insufficient Information 7 7
Burn(s) 3 3
Erythema 2 2
Burning Sensation 2 2
Twitching 1 1
Impaired Healing 1 1
Electric Shock 1 1
Superficial (First Degree) Burn 1 1
Syncope/Fainting 1 1
Unspecified Heart Problem 1 1
Unspecified Eye / Vision Problem 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Skin Inflammation/ Irritation 1 1
Swelling/ Edema 1 1
Hypersensitivity/Allergic reaction 1 1
Inflammation 1 1
Itching Sensation 1 1
Muscle Weakness 1 1
Neuropathy 1 1
Pain 1 1
Scar Tissue 1 1
Tachycardia 1 1
Arrhythmia 1 1
Arthritis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Spacelabs Healthcare, Ltd. II Dec-17-2024
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