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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
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
BIOTRICITY
  SUBSTANTIALLY EQUIVALENT 1
BRAEMAR CORP.
  SUBSTANTIALLY EQUIVALENT 1
CARDIAC INSIGHT, INC.
  SUBSTANTIALLY EQUIVALENT 1
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

Device Problems MDRs with this Device Problem Events in those MDRs
Use of Device Problem 214 214
Patient Data Problem 3 3
Appropriate Term/Code Not Available 2 2
Patient-Device Incompatibility 2 2
Loss of or Failure to Bond 2 2
False Negative Result 1 1
Incorrect Interpretation of Signal 1 1
Failure to Sense 1 1
Output Problem 1 1
No Apparent Adverse Event 1 1
Defective Device 1 1
Device Handling Problem 1 1
Device Alarm System 1 1
Failure To Adhere Or Bond 1 1
Display Difficult to Read 1 1
Loose or Intermittent Connection 1 1
Misconnection 1 1
Improper or Incorrect Procedure or Method 1 1
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Skin Irritation 182 182
Skin Inflammation/ Irritation 31 31
No Known Impact Or Consequence To Patient 7 7
No Code Available 4 4
No Consequences Or Impact To Patient 3 3
No Clinical Signs, Symptoms or Conditions 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Ventricle, Abnormality Of 1 1
Reaction 1 1
Blood Loss 1 1
Tissue Breakdown 1 1
Alteration In Body Temperature 1 1
Abrasion 1 1
Arrhythmia 1 1
Bacterial Infection 1 1
Death 1 1
Purulent Discharge 1 1
Pain 1 1
Scarring 1 1

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