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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device amplifier and signal conditioner, transducer signal
Regulation Description Transducer signal amplifier and conditioner.
Product CodeDRQ
Regulation Number 870.2060
Device Class 2


Premarket Reviews
ManufacturerDecision
ACIST MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 2 2
2017 3 3
2018 1 1
2020 5 5
2021 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Device Operates Differently Than Expected 3 3
Communication or Transmission Problem 2 2
Power Conditioning Problem 2 2
Failure to Power Up 2 2
Material Separation 1 1
Device Inoperable 1 1
Defective Device 1 1
Device Displays Incorrect Message 1 1
Detachment of Device or Device Component 1 1
Electrical Power Problem 1 1
Component Falling 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 6 6
No Known Impact Or Consequence To Patient 5 5
No Clinical Signs, Symptoms or Conditions 3 3
No Patient Involvement 1 1

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