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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 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
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 47 47

Device Problems MDRs with this Device Problem Events in those MDRs
Use of Device Problem 284 284
Patient-Device Incompatibility 61 61
Patient Data Problem 30 30
Adverse Event Without Identified Device or Use Problem 27 27
Improper or Incorrect Procedure or Method 6 6
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
Device Slipped 1 1
Reset Problem 1 1
False Negative Result 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 177 177
Skin Irritation 122 122
Skin Infection 45 45
No Clinical Signs, Symptoms or Conditions 29 29
Hypersensitivity/Allergic reaction 15 15
Insufficient Information 14 14
Blister 13 13
Contact Dermatitis 10 10
Unspecified Heart Problem 8 8
Itching Sensation 8 8
Rash 6 6
Arrhythmia 5 5
Erythema 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
No Code Available 4 4
Unspecified Tissue Injury 4 4
Swelling/ Edema 3 3
Fluid Discharge 3 3
Scar Tissue 3 3
Burn(s) 3 3
Urticaria 3 3
No Known Impact Or Consequence To Patient 2 2
Skin Discoloration 2 2
Cellulitis 2 2
Pain 2 2
Tachycardia 2 2
Skin Tears 2 2
No Consequences Or Impact To Patient 2 2
Bruise/Contusion 2 2
Skin Burning Sensation 2 2
Burning Sensation 1 1
Discomfort 1 1
Depression 1 1
Skin Disorders 1 1
Blood Loss 1 1
Reaction 1 1
Anaphylactoid 1 1
Anaphylactic Shock 1 1
Anxiety 1 1
Ventricle, Abnormality Of 1 1
Inflammation 1 1
Superficial (First Degree) Burn 1 1
Caustic/Chemical Burns 1 1
Loss of consciousness 1 1
Tissue Breakdown 1 1

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