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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 47 47

Device Problems MDRs with this Device Problem Events in those MDRs
Use of Device Problem 344 344
Patient-Device Incompatibility 62 62
Patient Data Problem 30 30
Adverse Event Without Identified Device or Use Problem 28 28
Improper or Incorrect Procedure or Method 8 8
Loss of or Failure to Bond 6 6
Insufficient Information 4 4
Patient Device Interaction Problem 4 4
Output Problem 3 3
Circuit Failure 2 2
Defective Device 2 2
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Device Handling Problem 2 2
Product Quality Problem 2 2
No Apparent Adverse Event 2 2
Device Operates Differently Than Expected 2 2
Appropriate Term/Code Not Available 2 2
Device Slipped 1 1
Reset Problem 1 1
False Negative Result 1 1
Device Alarm System 1 1
Display Difficult to Read 1 1
Wrong Label 1 1
Failure to Transmit Record 1 1
Failure to Sense 1 1
Therapeutic or Diagnostic Output Failure 1 1
Moisture Damage 1 1
Failure To Adhere Or Bond 1 1
Unable to Obtain Readings 1 1
Misconnection 1 1
Missing Information 1 1
Electromagnetic Interference 1 1
Incorrect Interpretation of Signal 1 1
Overheating of Device 1 1
Loose or Intermittent Connection 1 1
Device Displays Incorrect Message 1 1
Loss of Data 1 1
Temperature Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Skin Irritation 183 183
Skin Inflammation/ Irritation 177 177
Skin Infection 45 45
No Clinical Signs, Symptoms or Conditions 29 29
Hypersensitivity/Allergic reaction 15 15
Insufficient Information 14 14
Blister 13 13
No Known Impact Or Consequence To Patient 11 11
Contact Dermatitis 10 10
Unspecified Heart Problem 8 8
Itching Sensation 8 8
Rash 6 6
Erythema 6 6
Arrhythmia 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
No Code Available 4 4
No Consequences Or Impact To Patient 4 4
Unspecified Tissue Injury 4 4
Fluid Discharge 4 4
Pain 4 4
Urticaria 3 3
Swelling/ Edema 3 3
Scar Tissue 3 3
Burn(s) 3 3
Skin Burning Sensation 2 2
Bruise/Contusion 2 2
Tissue Breakdown 2 2
Skin Tears 2 2
Tachycardia 2 2
Reaction 2 2
Skin Discoloration 2 2
Cellulitis 2 2
Burn, Thermal 2 2
Burning Sensation 1 1
Discomfort 1 1
Depression 1 1
Alteration In Body Temperature 1 1
Skin Disorders 1 1
Blood Loss 1 1
Anaphylactic Shock 1 1
Anxiety 1 1
Anaphylactoid 1 1
Ventricle, Abnormality Of 1 1
Scarring 1 1
Purulent Discharge 1 1
Caustic/Chemical Burns 1 1
Abrasion 1 1
Bacterial Infection 1 1
Inflammation 1 1
Wheal(s) 1 1

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