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


Premarket Reviews
ManufacturerDecision
AEVICE HEALTH PTE. , LTD.
  SUBSTANTIALLY EQUIVALENT 2
ATSENS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
BARDY DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
EDAN INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ICENTIA, INC.
  SUBSTANTIALLY EQUIVALENT 1
IRHYTHM TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
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, INC.
  SUBSTANTIALLY EQUIVALENT 1
VITALOGRAPH , LTD.
  SUBSTANTIALLY EQUIVALENT 1
WEARLINQ, INC.
  SUBSTANTIALLY EQUIVALENT 1
WELLYSIS CORP.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2021 113 114
2022 46 46
2023 65 66
2024 88 88
2025 215 215
2026 94 94

Device Problems MDRs with this Device Problem Events in those MDRs
Patient-Device Incompatibility 371 371
Use of Device Problem 128 128
Adverse Event Without Identified Device or Use Problem 40 40
Patient Data Problem 35 35
Patient Device Interaction Problem 9 9
Improper or Incorrect Procedure or Method 7 7
Loss of or Failure to Bond 4 4
Output Problem 3 3
Insufficient Information 3 3
Biocompatibility 3 3
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Product Quality Problem 2 3
Overheating of Device 2 2
Failure to Charge 1 1
Device Slipped 1 1
Reset Problem 1 2
Communication or Transmission Problem 1 1
Restricted Flow rate 1 1
Unintended Electrical Shock 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
Adhesive Too Strong 1 1
Missing Test Results 1 1
Device Handling Problem 1 1
No Apparent Adverse Event 1 1
Missing Information 1 1
Protective Measures Problem 1 1
Electromagnetic Interference 1 1
Loss of Data 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Skin Inflammation/ Irritation 356 356
Hypersensitivity/Allergic reaction 129 129
Skin Infection 59 59
Contact Dermatitis 42 42
No Clinical Signs, Symptoms or Conditions 34 35
Blister 25 25
Itching Sensation 20 20
Anaphylactoid 17 17
Skin Burning Sensation 15 15
Erythema 15 15
Unspecified Heart Problem 14 14
Insufficient Information 14 15
Rash 12 12
Unspecified Tissue Injury 6 6
Scar Tissue 6 6
Burn(s) 6 6
Cellulitis 6 6
Skin Discoloration 5 5
Fluid Discharge 5 5
Skin Tears 5 5
Hemorrhage/Bleeding 5 5
Arrhythmia 4 4
Superficial (First Degree) Burn 4 4
Caustic/Chemical Burns 4 4
Bruise/Contusion 4 4
Burning Sensation 3 3
Swelling/ Edema 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Urticaria 3 3
Local Reaction 2 2
Pain 2 2
Dyspnea 2 2
Tachycardia 2 2
Pyrosis/Heartburn 1 1
Cardiac Arrest 1 1
Post Traumatic Wound Infection 1 1
Skin Disorders 1 1
Inflammation 1 1
Dizziness 1 1
Discomfort 1 1
Depression 1 1
Nausea 1 1
Anxiety 1 1
Anaphylactic Shock 1 1
Loss of consciousness 1 1
Heart Block 1 1
Full thickness (Third Degree) Burn 1 1
Atrial Flutter 1 1

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