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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 23 23

Device Problems MDRs with this Device Problem Events in those MDRs
Use of Device Problem 284 284
Patient-Device Incompatibility 48 48
Patient Data Problem 27 27
Adverse Event Without Identified Device or Use Problem 25 25
Improper or Incorrect Procedure or Method 6 6
Patient Device Interaction Problem 4 4
Output Problem 3 3
Loss of or Failure to Bond 3 3
Product Quality Problem 2 2
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Device Handling Problem 2 2
Appropriate Term/Code Not Available 2 2
Missing Information 1 1
Defective Device 1 1
Reset Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
No Apparent Adverse Event 1 1
Insufficient Information 1 1
Device Slipped 1 1
Unable to Obtain Readings 1 1
Electromagnetic Interference 1 1
False Negative Result 1 1
Loose or Intermittent Connection 1 1
Misconnection 1 1
Moisture Damage 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Skin Inflammation/ Irritation 168 168
Skin Irritation 122 122
Skin Infection 39 39
No Clinical Signs, Symptoms or Conditions 27 27
Hypersensitivity/Allergic reaction 13 13
Blister 12 12
Insufficient Information 12 12
Contact Dermatitis 9 9
Itching Sensation 8 8
Rash 6 6
Unspecified Heart Problem 6 6
Erythema 5 5
Arrhythmia 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
Urticaria 3 3
Scar Tissue 3 3
Tachycardia 2 2
Bruise/Contusion 2 2
Skin Tears 2 2
No Consequences Or Impact To Patient 2 2
Fluid Discharge 2 2
No Known Impact Or Consequence To Patient 2 2
Anaphylactoid 1 1
Skin Burning Sensation 1 1
Skin Disorders 1 1
Blood Loss 1 1
Tissue Breakdown 1 1
Superficial (First Degree) Burn 1 1
Anxiety 1 1
Discomfort 1 1
Reaction 1 1
Loss of consciousness 1 1
Burn(s) 1 1
Cellulitis 1 1
Anaphylactic Shock 1 1
Inflammation 1 1
Burning Sensation 1 1
Ventricle, Abnormality Of 1 1
Skin Discoloration 1 1
Pain 1 1

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