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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device cable, transducer and electrode, patient, (including connector)
Regulation Description Patient transducer and electrode cable (including connector).
Product CodeDSA
Regulation Number 870.2900
Device Class 2


Premarket Reviews
ManufacturerDecision
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
CAREFUSION 2200 INC.
  SUBSTANTIALLY EQUIVALENT 1
CAREFUSION 303, INC.
  SUBSTANTIALLY EQUIVALENT 1
CIEL MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
CURBELL MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
VOLCANO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 33 33
2016 28 28
2017 5 5
2018 15 15
2019 11 11
2020 15 15

Device Problems MDRs with this Device Problem Events in those MDRs
Cable, Electrical 27 27
Device Operates Differently Than Expected 21 21
Output Problem 10 10
Material Integrity Problem 9 9
Failure to Capture 8 8
Connection Problem 7 7
Defective Component 6 6
Device Sensing Problem 6 6
Failure of Device to Self-Test 5 5
Device Displays Incorrect Message 5 5
Sparking 5 5
Communication or Transmission Problem 4 4
Device Inoperable 4 4
Loose or Intermittent Connection 4 4
Peeled/Delaminated 3 3
Wire 3 3
Intermittent Capture 3 3
Defective Device 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Therapeutic or Diagnostic Output Failure 3 3
No Pacing 2 2
Scratched Material 2 2
Device Damaged Prior to Use 2 2
Smoking 2 2
Use of Device Problem 1 1
Out-Of-Box Failure 1 1
Failure to Form Staple 1 1
Arcing 1 1
Detachment of Device or Device Component 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Device Packaging Compromised 1 1
User Interface 1 1
Tube 1 1
Gasket 1 1
Break 1 1
Charred 1 1
Intermittent Continuity 1 1
Application Interface Becomes Non-Functional Or Program Exits Abnormally 1 1
No Display/Image 1 1
Electrical /Electronic Property Problem 1 1
Failure to Interrogate 1 1
Failure to Power Up 1 1
Product Quality Problem 1 1
Incorrect, Inadequate or Imprecise Resultor Readings 1 1
Inadequacy of Device Shape and/or Size 1 1
Incorrect Measurement 1 1
Mechanical Problem 1 1
No Device Output 1 1
Over-Sensing 1 1
Pacing Problem 1 1
Pacing Intermittently 1 1
Human-Device Interface Problem 1 1
Electrical Shorting 1 1
Patient Device Interaction Problem 1 1
Data Problem 1 1
Patient Data Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 44 44
No Patient Involvement 26 26
No Consequences Or Impact To Patient 21 21
Cardiac Arrest 9 9
Cardiopulmonary Arrest 1 1
Erythema 1 1
Tissue Damage 1 1
Ventricular Fibrillation 1 1
Cardiac Tamponade 1 1
Cardiac Perforation 1 1
Complete Heart Block 1 1
Not Applicable 1 1
No Information 1 1
Arrhythmia 1 1
Bradycardia 1 1
Burn(s) 1 1

Recalls
Manufacturer Recall Class Date Posted
1 GE Healthcare, LLC III Jun-26-2019
2 GN Otometrics II Sep-23-2019
3 Philips North America, LLC II Sep-09-2019
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