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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 1
ATSENS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
BARDY DIAGNOSTICS, INC
  SUBSTANTIALLY EQUIVALENT 4
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
2019 76 76
2020 91 91
2021 113 113
2022 46 46
2023 65 65
2024 90 90
2025 28 28

Device Problems MDRs with this Device Problem Events in those MDRs
Use of Device Problem 285 285
Patient-Device Incompatibility 112 112
Patient Data Problem 36 36
Adverse Event Without Identified Device or Use Problem 32 32
Improper or Incorrect Procedure or Method 7 7
Patient Device Interaction Problem 4 4
Loss of or Failure to Bond 4 4
Output Problem 3 3
Insufficient Information 3 3
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Device Handling Problem 2 2
Product Quality Problem 2 2
Appropriate Term/Code Not Available 2 2
Biocompatibility 2 2
Device Slipped 1 1
Reset Problem 1 1
False Negative Result 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
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 214 214
Skin Irritation 122 122
Skin Infection 46 46
Hypersensitivity/Allergic reaction 36 36
No Clinical Signs, Symptoms or Conditions 35 35
Contact Dermatitis 17 17
Blister 16 16
Insufficient Information 14 14
Itching Sensation 13 13
Unspecified Heart Problem 13 13
Erythema 10 10
Rash 9 9
Skin Burning Sensation 7 7
Anaphylactoid 6 6
Unspecified Tissue Injury 6 6
Arrhythmia 5 5
Skin Discoloration 5 5
Fluid Discharge 5 5
Scar Tissue 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
No Code Available 4 4
Hemorrhage/Bleeding 4 4
Skin Tears 4 4
Cellulitis 4 4
Urticaria 3 3
Swelling/ Edema 3 3
Burn(s) 3 3
Bruise/Contusion 2 2
No Consequences Or Impact To Patient 2 2
Tachycardia 2 2
Pain 2 2
Burning Sensation 2 2
No Known Impact Or Consequence To Patient 2 2
Local Reaction 2 2
Dyspnea 1 1
Depression 1 1
Reaction 1 1
Discomfort 1 1
Anaphylactic Shock 1 1
Anxiety 1 1
Skin Disorders 1 1
Blood Loss 1 1
Ventricle, Abnormality Of 1 1
Caustic/Chemical Burns 1 1
Inflammation 1 1
Dizziness 1 1
Loss of consciousness 1 1
Tissue Breakdown 1 1
Nausea 1 1
Superficial (First Degree) Burn 1 1

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