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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
NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD. (XLTEK)
  SUBSTANTIALLY EQUIVALENT 1
PATH MEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2019 5 5
2020 3 3
2021 3 3
2022 8 8
2023 6 6
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Sparking 7 7
Incorrect, Inadequate or Imprecise Result or Readings 4 4
Fire 2 2
Melted 2 2
Failure to Power Up 1 1
Unable to Obtain Readings 1 1
Material Frayed 1 1
Break 1 1
Degraded 1 1
False Negative Result 1 1
False Positive Result 1 1
Battery Problem 1 1
Component or Accessory Incompatibility 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
Smoking 1 1
Low impedance 1 1
Structural Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 17 17
No Known Impact Or Consequence To Patient 4 4
Not Applicable 2 2
Headache 1 1
Hearing Impairment 1 1
Pain 1 1
Rash 1 1
No Consequences Or Impact To Patient 1 1
Electric Shock 1 1

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