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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
PATH MEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2018 24 24
2019 5 5
2020 3 3
2021 3 3
2022 8 8
2023 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Device Slipped 20 20
Extrusion 20 20
Sparking 6 6
Incorrect, Inadequate or Imprecise Result or Readings 4 4
False Positive Result 4 4
Fire 2 2
Melted 2 2
Failure to Power Up 1 1
Unable to Obtain Readings 1 1
Battery Problem 1 1
Material Frayed 1 1
Break 1 1
Degraded 1 1
Smoking 1 1
Low impedance 1 1
Structural Problem 1 1
Device Tipped Over 1 1
Material Integrity Problem 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
Data Problem 1 1
Noise, Audible 1 1
Explosion 1 1
Unintended Electrical Shock 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 20 20
No Consequences Or Impact To Patient 18 18
No Clinical Signs, Symptoms or Conditions 15 15
Not Applicable 3 3
Hearing Loss 3 3
Pain 1 1
Rash 1 1
Headache 1 1
Hearing Impairment 1 1
Electric Shock 1 1
No Patient Involvement 1 1

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