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TPLC
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Device
stimulator, auditory, evoked response
Regulation Description
Evoked response auditory stimulator.
Product Code
GWJ
Regulation Number
882.1900
Device Class
2
Premarket Reviews
Manufacturer
Decision
GRASON STADLER
SUBSTANTIALLY EQUIVALENT
1
NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD. (XLTEK)
SUBSTANTIALLY EQUIVALENT
1
PATH MEDICAL GMBH
SUBSTANTIALLY EQUIVALENT
2
VIVOSONIC INC
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2020
3
3
2021
3
3
2022
8
8
2023
6
6
2024
7
7
Device Problems
MDRs with this Device Problem
Events in those MDRs
Sparking
8
8
Incorrect, Inadequate or Imprecise Result or Readings
3
3
Component or Accessory Incompatibility
2
2
Smoking
2
2
Fire
2
2
Melted
2
2
Insufficient Information
2
2
Material Integrity Problem
1
1
Device Displays Incorrect Message
1
1
False Negative Result
1
1
Structural Problem
1
1
Low impedance
1
1
Failure to Reset
1
1
Misassembly by Users
1
1
Noise, Audible
1
1
Data Problem
1
1
Unable to Obtain Readings
1
1
Failure to Power Up
1
1
No Apparent Adverse Event
1
1
Material Frayed
1
1
Therapeutic or Diagnostic Output Failure
1
1
Break
1
1
Appropriate Term/Code Not Available
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
21
21
No Known Impact Or Consequence To Patient
2
2
Not Applicable
1
1
Pain
1
1
Hypersensitivity/Allergic reaction
1
1
Hearing Impairment
1
1
Burn(s)
1
1
Headache
1
1
Rash
1
1
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