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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
GRASON STADLER
  SUBSTANTIALLY EQUIVALENT 1
INTELLIGENT HEARING SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
INTERACOUSTICS A/S
  SUBSTANTIALLY EQUIVALENT 1
PATH MEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 43 43
2018 24 24
2019 5 5
2020 3 3
2021 3 3
2022 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Device Slipped 53 53
Extrusion 50 50
Use of Device Problem 4 4
Device Issue 4 4
False Positive Result 4 4
Difficult to Remove 3 3
Incorrect, Inadequate or Imprecise Resultor Readings 3 3
Sparking 3 3
Physical Resistance/Sticking 2 2
Sticking 2 2
Fire 2 2
Material Frayed 1 1
Melted 1 1
Failure to Power Up 1 1
Signal Artifact/Noise 1 1
Break 1 1
Degraded 1 1
False Negative Result 1 1
Smoking 1 1
Structural Problem 1 1
Split 1 1
Device Tipped Over 1 1
Unintended Electrical Shock 1 1
Battery Problem 1 1
Low impedance 1 1
Therapeutic or Diagnostic Output Failure 1 1
Misassembly by Users 1 1
No Apparent Adverse Event 1 1
Appropriate Term/Code Not Available 1 1
Noise, Audible 1 1
Explosion 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 48 48
No Clinical Signs, Symptoms or Conditions 9 9
Hearing Loss 4 4
Not Applicable 3 3
Skin Irritation 2 2
Electric Shock 2 2
No Patient Involvement 1 1
Skin Tears 1 1
Pain 1 1
Abrasion 1 1
Erythema 1 1

Recalls
Manufacturer Recall Class Date Posted
1 GN Otometrics II Oct-23-2019
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