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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device recorder, magnetic tape, medical
Product CodeDSH
Regulation Number 870.2800
Device Class 2


Premarket Reviews
ManufacturerDecision
ANDON HEALTH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ATSENS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
BARDY DIAGNOSTICS, INC
  SUBSTANTIALLY EQUIVALENT 4
BARDY DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOTRICITY
  SUBSTANTIALLY EQUIVALENT 1
BRAEMAR MANUFACTURING, LLC
  SUBSTANTIALLY EQUIVALENT 1
CARDIAC INSIGHT, INC.
  SUBSTANTIALLY EQUIVALENT 1
DMS-SERVICE LLC
  SUBSTANTIALLY EQUIVALENT 1
GLOBAL INSTRUMENTATION LLC
  SUBSTANTIALLY EQUIVALENT 1
IRHYTHM TECHNOLOGIES, INC.
  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
STRADOS LABS
  SUBSTANTIALLY EQUIVALENT 1
STRADOS LABS, INC.
  SUBSTANTIALLY EQUIVALENT 1
WEARLINQ, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 31 31
2018 30 30
2019 76 76
2020 91 91
2021 113 113
2022 43 43

Device Problems MDRs with this Device Problem Events in those MDRs
Use of Device Problem 335 335
Patient-Device Incompatibility 12 12
Adverse Event Without Identified Device or Use Problem 11 11
Patient Data Problem 6 6
Defective Device 2 2
Appropriate Term/Code Not Available 2 2
Output Problem 2 2
Loss of or Failure to Bond 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
Electromagnetic Interference 1 1
False Negative Result 1 1
Loose or Intermittent Connection 1 1
Misconnection 1 1
Moisture Damage 1 1
No Apparent Adverse Event 1 1
Improper or Incorrect Procedure or Method 1 1
Device Alarm System 1 1
Failure To Adhere Or Bond 1 1
Device Handling Problem 1 1
Patient Device Interaction Problem 1 1
Missing Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Skin Irritation 177 177
Skin Inflammation/ Irritation 158 158
Skin Infection 9 9
Contact Dermatitis 8 8
Blister 7 7
No Known Impact Or Consequence To Patient 7 7
Itching Sensation 6 6
Rash 5 5
No Clinical Signs, Symptoms or Conditions 5 5
Insufficient Information 5 5
No Code Available 4 4
Swelling/ Edema 3 3
Arrhythmia 3 3
Erythema 3 3
No Consequences Or Impact To Patient 3 3
Hypersensitivity/Allergic reaction 2 2
Bruise/Contusion 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Fluid Discharge 2 2
Abrasion 1 1
Ventricle, Abnormality Of 1 1
Tachycardia 1 1
Burning Sensation 1 1
Skin Disorders 1 1
Purulent Discharge 1 1
Inflammation 1 1
Scarring 1 1
Pain 1 1
Urticaria 1 1
Reaction 1 1
Loss of consciousness 1 1
Skin Tears 1 1
Blood Loss 1 1
Tissue Breakdown 1 1
Alteration In Body Temperature 1 1
Superficial (First Degree) Burn 1 1

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