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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device stimulator, auditory, evoked response
Product CodeGWJ
Regulation Number 882.1900
Device Class 2


Premarket Reviews
ManufacturerDecision
FRYE ELECTRONICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
GN OTOMETRICS
  SUBSTANTIALLY EQUIVALENT 3
GN OTOMETRICS A/S
  SUBSTANTIALLY EQUIVALENT 2
GRASON STADLER
  SUBSTANTIALLY EQUIVALENT 1
INTELLIGENT HEARING SYSTEMS
  SUBSTANTIALLY EQUIVALENT 2
INTERACOUSTICS A/S
  SUBSTANTIALLY EQUIVALENT 2
MAICO DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1
NATUS MEDICAL INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD. (XLTEK)
  SUBSTANTIALLY EQUIVALENT 1
PATH MEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 4
R & D MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 3 3
2016 1 1
2017 43 43
2018 24 24
2019 5 5
2020 3 3
2021 3 3
2022 8 8
2023 6 6
2024 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Device Slipped 53 53
Extrusion 50 50
Sparking 8 8
Incorrect, Inadequate or Imprecise Result or Readings 5 5
Use of Device Problem 4 4
Insufficient Information 4 4
Device Issue 4 4
False Positive Result 4 4
Difficult to Remove 3 3
Component or Accessory Incompatibility 2 2
Sticking 2 2
Physical Resistance/Sticking 2 2
Fire 2 2
False Negative Result 2 2
Device Operates Differently Than Expected 2 2
Melted 2 2
Material Frayed 1 1
Signal Artifact/Noise 1 1
Material Integrity Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Smoking 1 1
Misassembly by Users 1 1
Data Problem 1 1
Degraded 1 1
Battery Problem 1 1
Unable to Obtain Readings 1 1
Failure to Power Up 1 1
Explosion 1 1
No Apparent Adverse Event 1 1
Failure to Reset 1 1
Noise, Audible 1 1
Device Tipped Over 1 1
Break 1 1
Split 1 1
Unintended Electrical Shock 1 1
Structural Problem 1 1
Low impedance 1 1
Appropriate Term/Code Not Available 1 1
Device Displays Incorrect Message 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 55 55
No Consequences Or Impact To Patient 49 49
No Clinical Signs, Symptoms or Conditions 20 20
Hearing Impairment 4 4
Hearing Loss 4 4
Not Applicable 3 3
Electric Shock 2 2
Skin Irritation 2 2
Pain 2 2
Hypersensitivity/Allergic reaction 1 1
Abrasion 1 1
Burn(s) 1 1
Rash 1 1
Erythema 1 1
No Patient Involvement 1 1
Skin Tears 1 1
Headache 1 1

Recalls
Manufacturer Recall Class Date Posted
1 GN Otometrics II Oct-23-2019
2 Intelligent Hearing Systems Corp. II May-27-2010
3 Natus Medical Inc II Aug-03-2010
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