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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 3
BIOTRICITY
  SUBSTANTIALLY EQUIVALENT 1
BIOTRICITY INC.
  SUBSTANTIALLY EQUIVALENT 1
BRAEMAR MANUFACTURING, LLC
  SUBSTANTIALLY EQUIVALENT 1
CARD GUARD SCIENTIFIC SURVIVAL, LTD.
  SUBSTANTIALLY EQUIVALENT 1
CARDIAC INSIGHT, INC.
  SUBSTANTIALLY EQUIVALENT 3
CARDIAC SCIENCE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
CARDIOCOMM SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
DMS-SERVICE LLC
  SUBSTANTIALLY EQUIVALENT 3
EDAN INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
GLOBAL INSTRUMENTATION LLC
  SUBSTANTIALLY EQUIVALENT 1
ICENTIA INC.
  SUBSTANTIALLY EQUIVALENT 1
IRHYTHM TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 5
KARMELSONIX
  SUBSTANTIALLY EQUIVALENT 1
LIFELENS TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
PEERBRIDGE HEALTH 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
VASOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 4
VIASYS HEALTHCARE GMBH
  SUBSTANTIALLY EQUIVALENT 1
VITALOGRAPH(IRELAND) LTD.
  SUBSTANTIALLY EQUIVALENT 1
WEARLINQ, INC.
  SUBSTANTIALLY EQUIVALENT 1
WELLYSIS CORP.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2014 3 3
2015 8 8
2016 6 6
2017 31 31
2018 30 30
2019 76 76
2020 91 91
2021 113 113
2022 46 46
2023 65 65
2024 23 23

Device Problems MDRs with this Device Problem Events in those MDRs
Use of Device Problem 344 344
Patient-Device Incompatibility 49 49
Patient Data Problem 27 27
Adverse Event Without Identified Device or Use Problem 26 26
Improper or Incorrect Procedure or Method 8 8
Loss of or Failure to Bond 5 5
Patient Device Interaction Problem 4 4
Output Problem 3 3
Defective Device 2 2
Device Handling Problem 2 2
Device Operates Differently Than Expected 2 2
No Apparent Adverse Event 2 2
Insufficient Information 2 2
Appropriate Term/Code Not Available 2 2
Circuit Failure 2 2
Product Quality Problem 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
Unable to Obtain Readings 1 1
Device Alarm System 1 1
Failure To Adhere Or Bond 1 1
Display Difficult to Read 1 1
Electromagnetic Interference 1 1
False Negative Result 1 1
Loose or Intermittent Connection 1 1
Misconnection 1 1
Moisture Damage 1 1
Overheating of Device 1 1
Missing Information 1 1
Device Displays Incorrect Message 1 1
Reset Problem 1 1
Temperature Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Skin Irritation 183 183
Skin Inflammation/ Irritation 168 168
Skin Infection 39 39
No Clinical Signs, Symptoms or Conditions 27 27
Hypersensitivity/Allergic reaction 13 13
Insufficient Information 12 12
Blister 12 12
No Known Impact Or Consequence To Patient 11 11
Contact Dermatitis 9 9
Itching Sensation 8 8
Rash 6 6
Erythema 6 6
Unspecified Heart Problem 6 6
Arrhythmia 5 5
No Consequences Or Impact To Patient 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Unspecified Tissue Injury 4 4
No Code Available 4 4
Swelling/ Edema 3 3
Urticaria 3 3
Fluid Discharge 3 3
Scar Tissue 3 3
Pain 3 3
Bruise/Contusion 2 2
Tissue Breakdown 2 2
Reaction 2 2
Skin Tears 2 2
Burn, Thermal 2 2
Tachycardia 2 2
Burning Sensation 1 1
Ventricle, Abnormality Of 1 1
Anxiety 1 1
Discomfort 1 1
Anaphylactoid 1 1
Wheal(s) 1 1
Blood Loss 1 1
Loss of consciousness 1 1
Alteration In Body Temperature 1 1
Superficial (First Degree) Burn 1 1
Burn(s) 1 1
Cellulitis 1 1
Death 1 1
Purulent Discharge 1 1
Bacterial Infection 1 1
Abrasion 1 1
Anaphylactic Shock 1 1
Unspecified Infection 1 1
Inflammation 1 1
Scarring 1 1
Skin Discoloration 1 1
Skin Burning Sensation 1 1
Skin Disorders 1 1

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