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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
Product CodeDRQ
Regulation Number 870.2060
Device Class 2


Premarket Reviews
ManufacturerDecision
ACIST MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2015 1 1
2016 2 2
2017 3 3
2018 1 1
2020 5 5
2021 4 4
2022 6 6
2023 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Power Up 6 6
Defective Device 4 4
Device Operates Differently Than Expected 4 4
Power Conditioning Problem 3 3
Operating System Becomes Nonfunctional 3 3
Device Displays Incorrect Message 3 3
Communication or Transmission Problem 2 2
Material Integrity Problem 2 2
Electrical Power Problem 1 1
Detachment of Device or Device Component 1 1
Battery Problem 1 1
Material Separation 1 1
Device Inoperable 1 1
Signal Artifact/Noise 1 1
Component Falling 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 18 18
No Consequences Or Impact To Patient 7 7
No Known Impact Or Consequence To Patient 5 5
No Patient Involvement 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation II Jun-18-2015
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