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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 6
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 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
  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
2019 76 76
2020 91 91
2021 113 114
2022 46 46
2023 65 66
2024 88 88
2025 182 182

Device Problems MDRs with this Device Problem Events in those MDRs
Use of Device Problem 284 284
Patient-Device Incompatibility 255 255
Patient Data Problem 37 37
Adverse Event Without Identified Device or Use Problem 36 36
Improper or Incorrect Procedure or Method 7 7
Patient Device Interaction Problem 6 6
Output Problem 4 4
Loss of or Failure to Bond 4 4
Insufficient Information 3 3
Biocompatibility 3 3
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Device Handling Problem 2 2
Product Quality Problem 2 3
Appropriate Term/Code Not Available 2 2
Overheating of Device 2 2
Failure to Charge 1 1
Device Slipped 1 1
Reset Problem 1 2
False Negative Result 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
Missing Test Results 1 1
Misconnection 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 293 293
Skin Irritation 122 122
Hypersensitivity/Allergic reaction 104 104
Skin Infection 55 55
No Clinical Signs, Symptoms or Conditions 36 37
Contact Dermatitis 31 31
Blister 22 22
Itching Sensation 19 19
Skin Burning Sensation 14 14
Anaphylactoid 14 14
Erythema 14 14
Insufficient Information 14 15
Unspecified Heart Problem 13 13
Rash 12 12
Unspecified Tissue Injury 6 6
Scar Tissue 6 6
Arrhythmia 5 5
Skin Discoloration 5 5
Burn(s) 5 5
Fluid Discharge 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Superficial (First Degree) Burn 4 4
No Code Available 4 4
Bruise/Contusion 4 4
Hemorrhage/Bleeding 4 4
Skin Tears 4 4
Cellulitis 4 4
Urticaria 3 3
Swelling/ Edema 3 3
No Consequences Or Impact To Patient 2 2
Tachycardia 2 2
Dyspnea 2 2
Pain 2 2
Burning Sensation 2 2
No Known Impact Or Consequence To Patient 2 2
Local Reaction 2 2
Reaction 1 1
Depression 1 1
Discomfort 1 1
Anxiety 1 1
Anaphylactic Shock 1 1
Skin Disorders 1 1
Blood Loss 1 1
Caustic/Chemical Burns 1 1
Ventricle, Abnormality Of 1 1
Loss of consciousness 1 1
Inflammation 1 1
Heart Block 1 1
Tissue Breakdown 1 1
Full thickness (Third Degree) Burn 1 1

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