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TPLC
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Device
amplifier and signal conditioner, transducer signal
Product Code
DRQ
Regulation Number
870.2060
Device Class
2
Premarket Reviews
Manufacturer
Decision
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
2024
4
4
Device Problems
MDRs with this Device Problem
Events in those MDRs
Failure to Power Up
6
6
Material Integrity Problem
4
4
Defective Device
4
4
Device Operates Differently Than Expected
4
4
Communication or Transmission Problem
3
3
Power Conditioning Problem
3
3
Operating System Becomes Nonfunctional
3
3
Device Displays Incorrect Message
3
3
Signal Artifact/Noise
2
2
Material Separation
1
1
Detachment of Device or Device Component
1
1
Device-Device Incompatibility
1
1
Electrical Power Problem
1
1
Battery Problem
1
1
Device Inoperable
1
1
Component Falling
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
22
22
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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