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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
Regulation Description Medical magnetic tape recorder.
Product CodeDSH
Regulation Number 870.2800
Device Class 2


Premarket Reviews
ManufacturerDecision
ANDON HEALTH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BARDY DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOTRICITY
  SUBSTANTIALLY EQUIVALENT 1
BRAEMAR CORP.
  SUBSTANTIALLY EQUIVALENT 1
CARDIAC INSIGHT, INC.
  SUBSTANTIALLY EQUIVALENT 1
  1.  K162503  Stealth System, Stealth Sensor, Stealth Smart Cabl ...
DMS-SERVICE LLC
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2016 6 6
2017 31 31
2018 30 30
2019 76 76
2020 91 91
2021 15 15

Device Problems MDRs with this Device Problem Events in those MDRs
Use of Device Problem 224 224
Patient Data Problem 4 4
Adverse Event Without Identified Device or Use Problem 3 3
Patient-Device Incompatibility 2 2
Appropriate Term/Code Not Available 2 2
Loss of or Failure to Bond 2 2
Display Difficult to Read 1 1
Electromagnetic Interference 1 1
False Negative Result 1 1
Loose or Intermittent Connection 1 1
Misconnection 1 1
Product Quality Problem 1 1
Incorrect, Inadequate or Imprecise Resultor Readings 1 1
Incorrect Interpretation of Signal 1 1
Failure to Sense 1 1
Output Problem 1 1
No Apparent Adverse Event 1 1
Improper or Incorrect Procedure or Method 1 1
Defective Device 1 1
Device Alarm System 1 1
Failure To Adhere Or Bond 1 1
Device Handling Problem 1 1
Missing Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Skin Irritation 182 182
Skin Inflammation/ Irritation 41 41
No Known Impact Or Consequence To Patient 7 7
No Clinical Signs, Symptoms or Conditions 4 4
No Code Available 4 4
No Consequences Or Impact To Patient 3 3
Insufficient Information 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Abrasion 1 1
Erythema 1 1
Hypersensitivity/Allergic reaction 1 1
Rash 1 1
Blister 1 1
Swelling/ Edema 1 1
Arrhythmia 1 1
Bacterial Infection 1 1
Death 1 1
Purulent Discharge 1 1
Pain 1 1
Scarring 1 1
Ventricle, Abnormality Of 1 1
Reaction 1 1
Blood Loss 1 1
Tissue Breakdown 1 1
Alteration In Body Temperature 1 1

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