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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device recorder, magnetic tape, medical
Product CodeDSH
Regulation Number 870.2800
Device Class 2


Premarket Reviews
ManufacturerDecision
AEVICE HEALTH PTE. LTD.
  SUBSTANTIALLY EQUIVALENT 1
ATSENS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
BARDY DIAGNOSTICS, INC
  SUBSTANTIALLY EQUIVALENT 1
BARDY DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
BIOTRICITY
  SUBSTANTIALLY EQUIVALENT 1
EDAN INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
GLOBAL INSTRUMENTATION LLC
  SUBSTANTIALLY EQUIVALENT 1
ICENTIA INC.
  SUBSTANTIALLY EQUIVALENT 1
IRHYTHM TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
LIFELENS TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEZOO CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
QARDIO INC.
  SUBSTANTIALLY EQUIVALENT 1
QUANTA COMPUTER INC.
  SUBSTANTIALLY EQUIVALENT 1
SOMNOMEDICS GMBH
  SUBSTANTIALLY EQUIVALENT 1
STRADOS LABS
  SUBSTANTIALLY EQUIVALENT 1
STRADOS LABS, INC.
  SUBSTANTIALLY EQUIVALENT 1
WEARLINQ, INC.
  SUBSTANTIALLY EQUIVALENT 1
WELLYSIS CORP.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2020 91 91
2021 113 113
2022 46 46
2023 65 65
2024 90 90

Device Problems MDRs with this Device Problem Events in those MDRs
Use of Device Problem 215 215
Patient-Device Incompatibility 90 90
Patient Data Problem 34 34
Adverse Event Without Identified Device or Use Problem 29 29
Improper or Incorrect Procedure or Method 7 7
Patient Device Interaction Problem 4 4
Loss of or Failure to Bond 4 4
Insufficient Information 3 3
Output Problem 2 2
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Device Handling Problem 2 2
Product Quality Problem 2 2
Device Slipped 1 1
Reset Problem 1 1
Restricted Flow rate 1 1
Wrong Label 1 1
Failure to Transmit Record 1 1
Defective Device 1 1
Therapeutic or Diagnostic Output Failure 1 1
Moisture Damage 1 1
Unable to Obtain Readings 1 1
No Apparent Adverse Event 1 1
Missing Information 1 1
Electromagnetic Interference 1 1
Loose or Intermittent Connection 1 1
Loss of Data 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Skin Inflammation/ Irritation 200 200
Skin Irritation 55 55
Skin Infection 45 45
No Clinical Signs, Symptoms or Conditions 35 35
Hypersensitivity/Allergic reaction 25 25
Contact Dermatitis 15 15
Blister 15 15
Insufficient Information 14 14
Unspecified Heart Problem 12 12
Itching Sensation 12 12
Erythema 9 9
Rash 8 8
Skin Burning Sensation 6 6
Unspecified Tissue Injury 6 6
Fluid Discharge 5 5
Hemorrhage/Bleeding 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Arrhythmia 4 4
Anaphylactoid 4 4
Scar Tissue 4 4
Cellulitis 4 4
Skin Discoloration 4 4
Skin Tears 3 3
Swelling/ Edema 3 3
Burn(s) 3 3
Urticaria 3 3
Burning Sensation 2 2
Pain 2 2
Tachycardia 2 2
Local Reaction 2 2
Bruise/Contusion 2 2
Discomfort 1 1
Depression 1 1
Skin Disorders 1 1
Reaction 1 1
Blood Loss 1 1
Anaphylactic Shock 1 1
Anxiety 1 1
Inflammation 1 1
Dizziness 1 1
No Code Available 1 1
Caustic/Chemical Burns 1 1
Nausea 1 1
Superficial (First Degree) Burn 1 1
Loss of consciousness 1 1
Tissue Breakdown 1 1

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