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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
ANDON HEALTH CO., 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
BRAEMAR MANUFACTURING, LLC
  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
SMART SOLUTIONS TECHNOLOGIES SL
  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
2018 30 30
2019 76 76
2020 91 91
2021 113 113
2022 46 46
2023 65 65
2024 24 24

Device Problems MDRs with this Device Problem Events in those MDRs
Use of Device Problem 307 307
Patient-Device Incompatibility 49 49
Patient Data Problem 27 27
Adverse Event Without Identified Device or Use Problem 25 25
Improper or Incorrect Procedure or Method 6 6
Loss of or Failure to Bond 5 5
Patient Device Interaction Problem 4 4
Output Problem 3 3
Device Handling Problem 2 2
No Apparent Adverse Event 2 2
Appropriate Term/Code Not Available 2 2
Product Quality Problem 2 2
Defective Device 2 2
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Incorrect Interpretation of Signal 1 1
Failure to Sense 1 1
Device Slipped 1 1
Loss of Data 1 1
Unable to Obtain Readings 1 1
Device Alarm System 1 1
Failure To Adhere Or Bond 1 1
Electromagnetic Interference 1 1
False Negative Result 1 1
Loose or Intermittent Connection 1 1
Misconnection 1 1
Moisture Damage 1 1
Missing Information 1 1
Insufficient Information 1 1
Reset Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Skin Inflammation/ Irritation 168 168
Skin Irritation 146 146
Skin Infection 39 39
No Clinical Signs, Symptoms or Conditions 27 27
Insufficient Information 13 13
Hypersensitivity/Allergic reaction 13 13
Blister 12 12
Contact Dermatitis 9 9
Itching Sensation 8 8
No Known Impact Or Consequence To Patient 7 7
Rash 6 6
Unspecified Heart Problem 6 6
Arrhythmia 5 5
Erythema 5 5
No Code Available 4 4
Unspecified Tissue Injury 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Swelling/ Edema 3 3
No Consequences Or Impact To Patient 3 3
Urticaria 3 3
Scar Tissue 3 3
Pain 2 2
Bruise/Contusion 2 2
Tachycardia 2 2
Fluid Discharge 2 2
Skin Tears 2 2
Blood Loss 1 1
Tissue Breakdown 1 1
Alteration In Body Temperature 1 1
Superficial (First Degree) Burn 1 1
Burning Sensation 1 1
Anaphylactoid 1 1
Anxiety 1 1
Discomfort 1 1
Reaction 1 1
Loss of consciousness 1 1
Burn(s) 1 1
Cellulitis 1 1
Purulent Discharge 1 1
Inflammation 1 1
Abrasion 1 1
Anaphylactic Shock 1 1
Ventricle, Abnormality Of 1 1
Scarring 1 1
Skin Discoloration 1 1
Skin Burning Sensation 1 1
Skin Disorders 1 1

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